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2. Race-related Differences in Sipuleucel-T Response Among Men with Metastatic Castrate-Resistant Prostate Cancer

Author

Heath, Elisabeth I., primary, Thakur, Archana, additional, Chen, Wei, additional, Hwang, Clara, additional, Paller, Channing J., additional, Cackowski, Frank C, additional, Boerner, Julie L., additional, Heilbrun, Lance, additional, Smith, Melanie P., additional, Schalk, Dana L., additional, Schienschang, Amy, additional, Whitaker, Sarah A., additional, Polend, Amanda, additional, Smith, Daryn, additional, Vaishampayan, Ulka N., additional, Dickow, Brenda, additional, and Lum, Lawrence G., additional

Published
2024
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4. Targeting GD2-positive Refractory/Resistant Neuroblastoma and Osteosarcoma with Anti- CD3 x Anti-GD2 Bispecific Antibody Armed T cells

Author

Yankelevich, Maxim, primary, Thakur, Archana, additional, Modak, Shakeel, additional, Chu, Roland, additional, Taub, Jeffrey, additional, Martin, Alissa, additional, Schalk, Dana L., additional, Schienshang, Amy, additional, Whitaker, Sara, additional, Rea, Katie, additional, Lee, Daniel W., additional, Liu, Qin, additional, Shields, Anthony, additional, Cheung, Nai-Kong, additional, and Lum, Lawrence G., additional

Published
2023
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7. Supplementary Figure S2 from Phase II Trial of Pembrolizumab and Anti-CD3 x Anti-HER2 Bispecific Antibody-Armed Activated T Cells in Metastatic Castration-Resistant Prostate Cancer

Author

Vaishampayan, Ulka N., primary, Thakur, Archana, primary, Chen, Wei, primary, Deol, Abhinav, primary, Patel, Meera, primary, Dobson, Kimberlee, primary, Dickow, Brenda, primary, Schalk, Dana, primary, Schienschang, Amy, primary, Whitaker, Sarah, primary, Polend, Amanda, primary, Fontana, Joseph A., primary, Heath, Elisabeth I., primary, and Lum, Lawrence G., primary

Published
2023
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8. Supplementary Table S2 from Phase II Trial of Pembrolizumab and Anti-CD3 x Anti-HER2 Bispecific Antibody-Armed Activated T Cells in Metastatic Castration-Resistant Prostate Cancer

Author

Vaishampayan, Ulka N., primary, Thakur, Archana, primary, Chen, Wei, primary, Deol, Abhinav, primary, Patel, Meera, primary, Dobson, Kimberlee, primary, Dickow, Brenda, primary, Schalk, Dana, primary, Schienschang, Amy, primary, Whitaker, Sarah, primary, Polend, Amanda, primary, Fontana, Joseph A., primary, Heath, Elisabeth I., primary, and Lum, Lawrence G., primary

Published
2023
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9. Data from Phase II Trial of Pembrolizumab and Anti-CD3 x Anti-HER2 Bispecific Antibody-Armed Activated T Cells in Metastatic Castration-Resistant Prostate Cancer

Author

Vaishampayan, Ulka N., primary, Thakur, Archana, primary, Chen, Wei, primary, Deol, Abhinav, primary, Patel, Meera, primary, Dobson, Kimberlee, primary, Dickow, Brenda, primary, Schalk, Dana, primary, Schienschang, Amy, primary, Whitaker, Sarah, primary, Polend, Amanda, primary, Fontana, Joseph A., primary, Heath, Elisabeth I., primary, and Lum, Lawrence G., primary

Published
2023
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13. Phase II Trial of Pembrolizumab and Anti-CD3 x Anti-HER2 Bispecific Antibody-Armed Activated T Cells in Metastatic Castration-Resistant Prostate Cancer

Author

Vaishampayan, Ulka N., primary, Thakur, Archana, additional, Chen, Wei, additional, Deol, Abhinav, additional, Patel, Meera, additional, Dobson, Kimberlee, additional, Dickow, Brenda, additional, Schalk, Dana, additional, Schienschang, Amy, additional, Whitaker, Sarah, additional, Polend, Amanda, additional, Fontana, Joseph A., additional, Heath, Elisabeth I., additional, and Lum, Lawrence G., additional

Published
2022
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15. Convalescent Plasma for Preventing Critical Illness in COVID-19: a Phase 2 Trial and Immune Profile

Author

Sturek, Jeffrey M., primary, Thomas, Tania A., additional, Gorham, James D., additional, Sheppard, Chelsea A., additional, Raymond, Allison H., additional, Petros De Guex, Kristen, additional, Harrington, William B., additional, Barros, Andrew J., additional, Madden, Gregory R., additional, Alkabab, Yosra M., additional, Lu, David Y., additional, Liu, Qin, additional, Poulter, Melinda D., additional, Mathers, Amy J., additional, Thakur, Archana, additional, Schalk, Dana L., additional, Kubicka, Ewa M., additional, Lum, Lawrence G., additional, and Heysell, Scott K., additional

Published
2022
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16. A phase I study targeting newly diagnosed glioblastoma with anti-CD3 × anti-EGFR bispecific antibody armed T cells (EGFR BATs) in combination with radiation and temozolomide

Author

Fadul, Camilo, primary, Kim, Jungeun, additional, Thakur, Archana, additional, Kassay-McAllister, Jessica, additional, Schalk, Dana, additional, kubicka, Ewa, additional, Purow, Benjamin, additional, Lopes, Beatriz, additional, Schiff, David, additional, Donahue, Joseph, additional, Dillon, Patrick, additional, Le, Tri, additional, Liu, Qin, additional, and Lum, Lawrence, additional

Published
2022
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18. Phase II clinical trial using anti-CD3 × anti-HER2 bispecific antibody armed activated T cells (HER2 BATs) consolidation therapy for HER2 negative (0–2+) metastatic breast cancer

Author

Lum, Lawrence G., primary, Al-Kadhimi, Zaid, additional, Deol, Abhinav, additional, Kondadasula, Vidya, additional, Schalk, Dana, additional, Tomashewski, Elyse, additional, Steele, Patricia, additional, Fields, Kristie, additional, Giroux, Melissa, additional, Liu, Qin, additional, Flaherty, Lawrence, additional, Simon, Michael, additional, and Thakur, Archana, additional

Published
2021
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24. Clinical and immune responses to anti-CD3 x anti-EGFR bispecific antibody armed activated T cells (EGFR BATs) in pancreatic cancer patients

Author

Lum, Lawrence G., primary, Thakur, Archana, additional, Choi, Minsig, additional, Deol, Abhinav, additional, Kondadasula, Vidya, additional, Schalk, Dana, additional, Fields, Kristie, additional, Dufrense, Melissa, additional, Philip, Philip, additional, Dyson, Gregory, additional, Aon, Hussein D., additional, and Shields, Anthony F., additional

Published
2020
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25. Abstract 5036: Induction of highly efficacious anti-tumor activity and modulation of tumor microenvironment: Cell-free off the shelf therapeutic modality

Author

Thakur, Archana, primary, Yarlagadda, SriVidya, additional, Ji, Kyungmin, additional, Schalk, Dana L., additional, Ung, Johnson, additional, Bliemeister, Edwin T., additional, Aboukameel, Amro, additional, Casarez, Eli, additional, Sloane, Bonnie F., additional, and Lum, Lawrence G., additional

Published
2019
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27. Clinical and immune responses using anti-CD3 x anti-EGFR bispecific antibody armed T cells (BATs) for locally advanced or metastatic pancreatic cancer.

Author

Lum, Lawrence G., primary, Le, Tri Minh, additional, Choi, Minsig, additional, Thakur, Archana, additional, Reilley, Matthew, additional, Kunk, Paul Raymond, additional, Deol, Abhinav, additional, Ballen, Karen K., additional, Kindwall-Keller, Tamila L., additional, Schalk, Dana, additional, Kubicka, Ewa, additional, Huang, Manley, additional, Philip, Philip Agop, additional, Aoun, Hussein, additional, Dyson, Gregory, additional, Liu, Qin, additional, and Shields, Anthony Frank, additional

Published
2019
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30. Preferential expression of functional IL-17R in glioma stem cells: potential role in self-renewal

Author

Parajuli, Prahlad, primary, Anand, Rohit, additional, Mandalaparty, Chandramouli, additional, Suryadevara, Raviteja, additional, Sriranga, Preethi U., additional, Michelhaugh, Sharon K., additional, Cazacu, Simona, additional, Finniss, Susan, additional, Thakur, Archana, additional, Lum, Lawrence G., additional, Schalk, Dana, additional, Brodie, Chaya, additional, and Mittal, Sandeep, additional

Published
2016
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31. Vaccination with bispecific antibody armed T cells (BATC) in metastatic breast cancer patients and transfer of anti-breast cancer immunity in primed T cells after stem cell transplant: a proof of principle study

Author

Thakur, Archana, primary, Lum, Lawrence G, additional, Kondadasule, Vidya, additional, Rathore, Ritesh, additional, Al-Kadhimi, Zaid, additional, Tomaszewski, Elyse, additional, Schalk, Dana, additional, Uberti, Joseph, additional, and Ratanatharathorn, Voravit, additional

Published
2015
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32. Transfer of anti-breast cancer immunity induced by infusions of bispecific antibody armed T cells and boosted with ex vivo primed T cells after stem cell transplant in metastatic breast cancer patients.

Author

Thakur, Archana, primary, Lum, Lawrence G., additional, Rathore, Ritesh, additional, Al-Kadhimi, Zaid, additional, Tomaszewski, Elyse, additional, Schalk, Dana, additional, Liu, Qin, additional, Uberti, Joseph P., additional, and Ratanatharathorn, Voravit, additional

Published
2015
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33. Five advanced pancreatic cancer patients in a Phase I study of anti-CD3 x anti-EGFR bispecific antibody armed activated T cells (BATS)

Author

Lum, Lawrence G, primary, Choi, Minsig, additional, Thakur, Archana, additional, Deol, Abhinav, additional, Fields, Kristie, additional, Tomaszewski, Elyse, additional, Schalk, Dana, additional, Kondadasule, Vidya, additional, Dyson, Greg, additional, Mahaseth, Hemchandra, additional, Philip, Philip, additional, and Shields, Anthony, additional

Published
2015
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34. Maspin expression in prostate tumor elicits host anti-tumor immunity

Author

Dzinic, Sijana H., primary, Chen, Kang, additional, Thakur, Archana, additional, Kaplun, Alexander, additional, Daniel Bonfil, R., additional, Li, Xiaohua, additional, Liu, Jason, additional, Margarida Bernardo, M., additional, Saliganan, Allen, additional, Back, Jessica B., additional, Yano, Hiroshi, additional, Schalk, Dana L., additional, Tomaszewski, Elyse N., additional, Beydoun, Ahmed S., additional, Dyson, Gregory, additional, Mujagic, Adelina, additional, Krass, David, additional, Dean, Ivory, additional, Mi, Qing-Sheng, additional, Heath, Elisabeth, additional, Sakr, Wael, additional, Lum, Lawrence G., additional, and Sheng, Shijie, additional

Published
2014
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35. Phase II trial evaluating HER2 targeted activated T cells in advanced HER2 low expressing breast cancer patients.

Author

Jagtap, Deepa Bai, primary, Thakur, Archana, additional, Deol, Abhinav, additional, Al-Kadhimi, Zaid, additional, Simon, Michael S., additional, Flaherty, Lawrence E., additional, Shields, Anthony Frank, additional, Schalk, Dana, additional, Paul, Elyse, additional, Kondadasula, Vidya, additional, Liu, Qin, additional, and Lum, Lawrence G., additional

Published
2014
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36. Induction Of Anti-Myeloma Cellular and Humoral Immunity By Pre-Targeting Clonogenic Myeloma Cells Prior To Stem Cell Transplant With T Cells Armed With Anti-CD3 x Anti-CD20 Bispecific Antibody Leads To Transfer Of Cellular and Humoral Anti-Myeloma Immunity

Author

Lum, Lawrence G, primary, Thakur, Archana, additional, Al-Kadhimi, Zaid, additional, Deol, Abhinav, additional, Ayash, Lois, additional, Tomaszewski, Elyse N., additional, Yano, Hiroshi, additional, Schalk, Dana L, additional, Kondadasula, Sri Vidya, additional, Steele, Patricia A., additional, Zonder, Jeffrey A., additional, Uberti, Joseph P., additional, Ratanatharathorn, Voravit, additional, and Abidi, Muneer H., additional

Published
2013
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39. Transfer of Cellular and Humoral Anti-Tumor Immunity with Immune T Cells After Stem Cell Transplant (SCT) for Metastatic Breast Cancer Following “Vaccination” with Anti-CD3 x Anti-Her2/Neu Bispecific Antibody (Her2Bi) Armed Activated T Cells

Author

Thakur, Archana, primary, Al-Kadhimi, Zaid, additional, Pray, Cassara, additional, Tomaszewski, Elyse N., additional, Rathore, Ritesh, additional, Steele, Patricia A., additional, Abidi, Muneer H., additional, Ayash, Lois, additional, Schalk, Dana L, additional, Myers, Karen, additional, Mitchell, Alice, additional, Deol, Abhinav, additional, Uberti, Joseph P., additional, Ratanatharathorn, Voravit, additional, and Lum, Lawrence G, additional

Published
2011
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42. Microenvironment generated during EGFR targeted killing of pancreatic tumor cells by ATC inhibits myeloid-derived suppressor cells through COX2 and PGE2 dependent pathway.

Author

Thakur, Archana, Schalk, Dana, Tomaszewski, Elyse, Kondadasula, Sri Vidya, Yano, Hiroshi, Sarkar, Fazlul H., and Lum, Lawrence G.

Subjects
*EPIDERMAL growth factor receptors, *PANCREATIC tumors, *SUPPRESSOR cells, *PROSTAGLANDINS E, *PANCREATIC cancer, *BISPECIFIC antibodies, *CYTOKINES
Abstract

Background: Myeloid-derived suppressor cells (MDSCs) are one of the major components of the immune-suppressive network, play key roles in tumor progression and limit therapeutic responses. Recently, we reported that tumor spheres formed by breast cancer cell lines were visibly smaller in a Th1 enriched microenvironment with significantly reduced differentiation of MDSC populations in 3D culture. In this study, we investigated the mechanism(s) of bispecific antibody armed ATC mediated inhibition of MDSC in the presence or absence of Th1 microenvironment. Methods: We used 3D co-culture model of peripheral blood mononuclear cells (PBMC) with pancreatic cancer cells MiaPaCa-2 [MiaE] and gemcitabine resistant MiaPaCa-GR [MiaM] cells to generate MDSC in the presence or absence of Th1 cytokines and EGFRBi armed ATC (aATC). Results: We show significantly decreased differentiation of MDSC (MiaE, p<0.005; MiaM, p<0.05) in the presence of aATC with or without Th1 cytokines. MDSC recovered from control cultures (without aATC) showed potent ability to suppress T cell functions compared to those recovered from aATC containing co-cultures. Reduced accumulation of MDSC was accompanied by significantly lower levels of COX2 (p<0.0048), PGE2 (p<0.03), and their downstream effector molecule Arginase-1 (p<0.01), and significantly higher levels of TNF-a, IL-12 and chemokines CCL3, CCL4, CCL5, CXCL9 and CXCL10 under aATC induced Th1 cytokine enriched microenvironment Conclusions: These data suggest aATC can suppress MDSC differentiation and attenuation of their suppressive activity through down regulation of COX2, PGE2 and ARG1 pathway that is potentiated in presence of Th1 cytokines, suggesting that Th1 enriching immunotherapy may be beneficial in pancreatic cancer treatment. [ABSTRACT FROM AUTHOR]

Published
2012
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43. B cells from patients with multiple sclerosis induce cell death via apoptosis in neurons in vitro.

Author

Nedelkoska, Liljana, Bealmear, Beverly, Lisak, Robert P., Benjamins, Joyce A., Schalk, Dana, Muirhead, Gillian, Touil, Hanane, Li, Rui, and Bar-Or, Amit

Subjects
*MULTIPLE sclerosis, *APOPTOSIS, *B cells, *CELL-mediated cytotoxicity, *OLIGODENDROGLIA, *PATIENTS
Abstract

B cells mediate multiple sclerosis (MS) pathogenesis by mechanisms unrelated to immunoglobulin (Ig). We reported that supernatants (Sup) from cultured B cells from blood of relapsing remitting MS (RRMS) patients, but not normal controls (NC), were cytotoxic to rat oligodendrocytes (OL). We now show that RRMS blood B cells, not stimulated in vitro , secrete factor/s toxic to rat and human neurons. Cytotoxicity is independent of Ig and multiple cytokines, not complement-mediated, and involves apoptosis. The factor/s have an apparent mw of > 300 kDa. B cells could contribute to damage within the central nervous system by secreting molecules toxic to OL and neurons. [ABSTRACT FROM AUTHOR]

Published
2017
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44. Targeting refractory/recurrent neuroblastoma and osteosarcoma with anti-CD3×anti-GD2 bispecific antibody armed T cells.

Author

Yankelevich M, Thakur A, Modak S, Chu R, Taub J, Martin A, Schalk D, Schienshang A, Whitaker S, Rea K, Lee DW, Liu Q, Shields AF, Cheung NV, and Lum LG

Subjects
Child, Humans, T-Lymphocytes pathology, Antibodies, Monoclonal pharmacology, Antibodies, Monoclonal therapeutic use, Neuroblastoma pathology, Antineoplastic Agents therapeutic use, Osteosarcoma drug therapy
Abstract

Background: The survival benefit observed in children with neuroblastoma (NB) and minimal residual disease who received treatment with anti-GD2 monoclonal antibodies prompted our investigation into the safety and potential clinical benefits of anti-CD3×anti-GD2 bispecific antibody (GD2Bi) armed T cells (GD2BATs). Preclinical studies demonstrated the high cytotoxicity of GD2BATs against GD2+cell lines, leading to the initiation of a phase I/II study in recurrent/refractory patients., Methods: The 3+3 dose escalation phase I study (NCT02173093) encompassed nine evaluable patients with NB (n=5), osteosarcoma (n=3), and desmoplastic small round cell tumors (n=1). Patients received twice-weekly infusions of GD2BATs at 40, 80, or 160×10 6 GD2BATs/kg/infusion complemented by daily interleukin-2 (300,000 IU/m 2 ) and twice-weekly granulocyte macrophage colony-stimulating factor (250 µg/m 2 ). The phase II segment focused on patients with NB at the dose 3 level of 160×10 6 GD2BATs/kg/infusion., Results: Of the 12 patients enrolled, 9 completed therapy in phase I with no dose-limiting toxicities. Mild and manageable cytokine release syndrome occurred in all patients, presenting as grade 2-3 fevers/chills, headaches, and occasional hypotension up to 72 hours after GD2BAT infusions. GD2-antibody-associated pain was minimal. Median overall survival (OS) for phase I and the limited phase II was 18.0 and 31.2 months, respectively, with a combined OS of 21.1 months. A phase I NB patient had a complete bone marrow response with overall stable disease. In phase II, 10 of 12 patients were evaluable: 1 achieved partial response, and 3 showed clinical benefit with prolonged stable disease. Over 50% of evaluable patients exhibited augmented immune responses to GD2+targets post-GD2BATs, as indicated by interferon-gamma (IFN-γ) EliSpots, Th1 cytokines, and/or chemokines., Conclusions: This study demonstrated the safety of GD2BATs up to 160×10 6  cells/kg/infusion. Coupled with evidence of post-treatment endogenous immune responses, our findings support further investigation of GD2BATs in larger phase II clinical trials., Competing Interests: Competing interests: LGL is co-founder of Transtarget and is a SAB member for Rapa Therapeutics. LGL is founder of BATs, LLC. LGL and AT were named as inventors in multiple patents filed by UV. Both MSK and N-KVC have financial interest in Y-mAbs, Abpro-Labs and Eureka Therapeutics. N-KVC reports receiving commercial research grants from Y-mabs Therapeutics and Abpro-Labs. N-KVC was named as inventor on multiple patents filed by MSK, including those licensed to Ymabs Therapeutics, Biotec Pharmacon, and Abpro-labs. N-KVC is a SAB member for Abpro-Labs and Eureka Therapeutics. AT is co-founder of Novo-Immune. DWL holds a CAR-T related patent and his university receives clinical trial funding from KITE Pharma/Gilead., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2024
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45. Targeting GD2-positive Refractory/Resistant Neuroblastoma and Osteosarcoma with Anti- CD3 x Anti-GD2 Bispecific Antibody Armed T cells.

Author

Yankelevich M, Thakur A, Modak S, Chu R, Taub J, Martin A, Schalk DL, Schienshang A, Whitaker S, Rea K, Lee DW, Liu Q, Shields A, Cheung NK, and Lum LG

Abstract

Background: Since treatment of neuroblastoma (NB) with anti-GD2 monoclonal antibodies provides a survival benefit in children with minimal residual disease and our preclinical study shows that anti-CD3 x anti-GD2 bispecific antibody (GD2Bi) armed T cells (GD2BATs) were highly cytotoxic to GD2+ cell lines, we conducted a phase I/II study in recurrent/refractory patients to establish safety and explore the clinical benefit of GD2BATs., Methods: The 3+3 dose escalation study (NCT02173093) phase I involved 9 evaluable patients with NB (n=5), osteosarcoma (OST) (n=3), and desmoplastic small round cell tumors (DSRCT) (n=1) with twice weekly infusions of GD2BATs at 40, 80, or 160 x 10 6 GD2BATs/kg/infusion with daily interleukin 2 (300,000 IU/m 2 ) and twice weekly granulocyte-macrophage colony stimulating factor (250 μg/m 2 ). Phase II portion of the trial was conducted in patients with NB at the dose 3 level of 160 x 10 6 GD2BATs/kg/infusion but failed to enroll the planned number of patients., Results: Nine of 12 patients in the phase I completed therapy. There were no dose limiting toxicities (DLTs). All patients developed mild and manageable cytokine release syndrome (CRS) with grade 2-3 fevers/chills, headaches, and occasional hypotension up to 72 hours after GD2BAT infusions. GD2-antibody associated pain was not significant in this study. The median OS for patients in the Phase I and limited Phase II was 18.0 and 31.2 months, respectively, whereas the combined OS was 21.1 months. There was a complete bone marrow response with overall stable disease in one of the phase I patients with NB. Ten of 12 phase II patients were evaluable for response: 1 had partial response. Three additional patients were deemed to have clinical benefit with prolonged stable disease. More than 50% of evaluable patients showed augmented immune responses to GD2+ targets after GD2BATs as measured by interferon-gamma (IFN-γ) EliSpots, Th1 cytokines, and/or chemokines., Conclusions: Our study demonstrated safety of up to 160 x 10 6 cells/kg/infusion of GD2BATs. Combined with evidence for the development of post treatment endogenous immune responses, this data supports further investigation of GD2 BATs in larger Phase II clinical trials., Competing Interests: Conflict of Interest: LGL is co-founder of Transtarget, Inc. and is a SAB member for Rapa Therapeutics, Inc. LGL is founder of BATs, LLC. LGL and AT were named as inventors in multiple patents filed by UV. Both MSK and NKC have financial interest in Y-mAbs, Abpro-Labs and Eureka Therapeutics. NKC reports receiving commercial research grants from Y-mabs Therapeutics and Abpro-Labs Inc. NKC was named as inventor on multiple patents filed by MSK, including those licensed to Ymabs Therapeutics, Biotec Pharmacon, and Abpro-labs. NKC is a SAB member for Abpro-Labs and Eureka Therapeutics. AT is co-founder of Novo-Immune. DWL holds a CAR-T related patent and his university receives clinical trial funding from KITE Pharma/Gilead.

Published
2023
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46. Phase II Trial of Pembrolizumab and Anti-CD3 x Anti-HER2 Bispecific Antibody-Armed Activated T Cells in Metastatic Castration-Resistant Prostate Cancer.

Author

Vaishampayan UN, Thakur A, Chen W, Deol A, Patel M, Dobson K, Dickow B, Schalk D, Schienschang A, Whitaker S, Polend A, Fontana JA, Heath EI, and Lum LG

Subjects
Male, Humans, Middle Aged, Aged, Aged, 80 and over, Docetaxel therapeutic use, Leukocytes, Mononuclear, T-Lymphocytes, Antineoplastic Combined Chemotherapy Protocols adverse effects, Prostatic Neoplasms, Castration-Resistant drug therapy
Abstract

Purpose: A phase II study was conducted to evaluate the safety and efficacy of the combination of HER2 bispecific antibody (HER2Bi)-armed activated T cells (HER2 BAT) and programmed death 1 inhibitor, pembrolizumab., Patients and Methods: Patients with metastatic castration-resistant prostate cancer (mCRPC) with 0 to 1 performance status and normal liver, kidney, and marrow function, pre- or post-docetaxel chemotherapy were eligible. Primary endpoint was 6-month progression-free survival (PFS). Peripheral blood mononuclear cells were obtained by a single apheresis, shipped to University of Virginia, activated with OKT3 and expanded for 14 days in IL2, harvested, and armed with HER2Bi and cryopreserved. HER2 BATs were infused twice weekly for 4 weeks and pembrolizumab was administered every 21 days for a maximum duration of 6 months starting 1 to 3 weeks prior to HER2 BATs infusion., Results: Fourteen patients were enrolled with a median age of 69 (range 57-82 years) and median PSA of 143.4 (range 8.2-4210 ng/dL). Two patients had peritoneal metastases, 1 had lymph node (LN) only metastases and 11 had bone metastases of which 7 had bone and LN metastases. All were pretreated with androgen receptor axis targeted agents and 7 (50%) had prior docetaxel chemotherapy. The toxicities were grade1-2 infusion reactions with fever, chills, headaches, nausea and/or myalgias. Primary endpoint of 6 month PFS was achieved in 5 of 14 patients (38.5%; 95% confidence interval, 19.5%-76.5%). Median PFS was 5 months and median survival was 31.6 months., Conclusions: The safety and promising efficacy makes this combination worthy of future investigation in mCRPC., (©2022 American Association for Cancer Research.)

Published
2023
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