CAR T Cell Clinical Trials

City of Hope’s comprehensive chimeric antigen receptor (CAR) T cell therapy program is addressing some of the hardest-to-treat cancers by accelerating innovative clinical research approaches.

 

neurosurgerymail@coh.org or 626-218-9393

 

Ongoing Trials

Ongoing CAR T clinical research initiated at City of Hope includes trials in:

Solid Tumors

• Brain tumors (glioblastoma, ependymoma or medulloblastoma) — IRB #19497
  Brain tumor-specific immune cells (IL13Ralpha2-CAR T Cells) for the treatment of leptomeningeal glioblastoma, ependymoma or medulloblastoma 
  PI: Lisa Feldman, M.D.
• Pediatric brain tumors — IRB #19130
  Phase I study of cellular immunotherapy using memory-enriched T cells lentivirally transduced to express an IL13Ra2-TARGETING, hinge-optimized, 41BB-costimulatory chimeric receptor and a truncated CD19 for children with recurrent/refractory malignant brain tumors
  PI: Leo Wang, M.D.
• Brain cancer (glioblastoma) — IRB #19309 
  CAR T cells with a chlorotoxin tumor-targeting domain for the treatment of MPP2+ recurrent or progressive glioblastoma 
  PI: Behnam Badie, M.D.
• Brain cancer (glioblastoma) — IRB #18251 
  IL13Ralpha2-targeted CAR T cells with or without nivolumab and ipilimumab in treating patients with recurrent or refractory glioblastoma 
  PI: Behnam Badie, M.D.
• Brain cancer (glioma) — IRB#16064
  Memory-enriched T cells in treating patients with recurrent or refractory grade III-IV glioma 
  PI: Behnam Badie, M.D.
• HER2-positive breast cancer that has metastasized to the brain — IRB #17237
  HER2-CAR T cells in treating participants with brain or leptomeningeal metastases 
  PI: Jana Portnow, M.D.
• Prostate cancer — IRB #17483 
  PSCA-CAR T cells in treating patients with PSCA+ metastatic castration-resistant prostate cancer 
  PI: Tanya Dorff, M.D.
• IRB #13384
  Phase I study of cellular immunotherapy using central memory-enriched T cells lentivirally transduced to express an IL13Rα2-specific, hinge-optimized, 41BB-costimulatory CAR and a truncated CD19 for patients with recurrent/refractory malignant glioma

Blood Cancers

• Leukemia
  • ALL — IRB #13447
    Cellular immunotherapy in treating patients with high-risk acute lymphoblastic leukemia 
    PI: Samer K. Khaled, M.D.
  • AML and blastic plasmacytoid dendritic cell neoplasm [BPDCN]) — IRB #13272
    Genetically modified T cell immunotherapy in treating patients with relapsed/refractory acute myeloid leukemia and persistent/recurrent blastic plasmacytoid dendritic cell neoplasm 
    PI: Elizabeth Lihua Budde, M.D., Ph.D.
• Lymphoma and leukemia
  • B cell cancers — IRB #13351 
    Cellular immunotherapy following chemotherapy in treating patients with recurrent Non-Hodgkin lymphomas, chronic lymphocytic leukemia or B cell prolymphocytic leukemia
    PI: Tanya Siddiqi, M.D.

Partner Trials

Solid Tumors

• HPV+ Tumors — IRB #19062 
  A Phase 1 study evaluating the safety and efficacy of HPV16 E7 T cell receptor engineered T cells (KITE-439) in HLA-A*02:01+ subjects with relapsed/refractory HPV16+ cancers 
  PI: Erminia Massarelli, M.D.
• Prostate cancer — IRB #19603 
  P-PSMA-101 CAR T cells in the treatment of subjects with metastatic castration-resistant prostate cancer (mCRPC) 
  PI: Tanya Dorff, M.D.
• Sarcoma — IRB #19194 
  A Phase 2 single arm, open-label clinical trial of ADP-A2M4 SPEAR™ T cells in subjects with advanced synovial sarcoma or myxoid/round cell liposarcoma 
  PI: Warren A. Chow, M.D.
• Sarcoma — NCT01343043
  A pilot study of genetically engineered NY-ESO-1 Specific NY-ESO-1c²⁵⁹T in HLA-A2+ patients with synovial sarcoma (NY-ESO-1)
  City of Hope
  PI: Warren A. Chow, M.D.
• Solid tumor — IRB #19292 
  Master protocol to assess the safety and antitumor activity of genetically engineered T cells in NY-ESO-1 and/or LAGE-1a positive solid tumors 
  PI: Warren A. Chow, M.D.
• Solid tumors (anus, breast, colon, melanoma/skin, ovary, prostate, rectum and urinary bladder) — IRB #19223 
  PACT-0101 NeoTCR-P1 with or without anti-PD-1 in locally advanced or metastatic solid tumors 
  PI: Mihaela Cristea, M.D.

Blood Cancers

• Diffuse large B cell lymphoma — NCT02631044 
  Study evaluating the safety and pharmacokinetics of JCAR017 in B cell Non-Hodgkin lymphoma
  PI: Tanya Siddiqi,M.D.
• DLBCL — IRB #19307 
  A Single-arm, open-label, multi-centre, Phase I/II study evaluating the safety and clinical activity of AUTO3, a CAR T cell treatment targeting CD19 and CD22 with anti-PD1 antibody in patients with relapsed or refractory diffuse large B cell lymphoma 
  PI: Elizabeth Lihua Budde, M.D., Ph.D.
• Large B Cell Lymphoma — IRB #19091 
  A Phase 2 open-label, multicenter study evaluating the safety and efficacy of axicabtagene ciloleucel in combination with either rituximab or lenalidomide in subjects with refractory large B cell lymphoma (ZUMA-14) 
  PI: Elizabeth Lihua Budde, M.D., Ph.D.
• Lymphoma — IRB #18344 
  Efficacy and safety of axicabtagene ciloleucel as first-line therapy in participants with high-risk large B cell lymphoma (ZUMA-12) 
  PI: Alex Herrera, M.D.
• Lymphoma — IRB #18101 
  A multicenter, open-label, expanded access study of axicabtagene ciloleucel for the treatment of subjects with relapsed/refractory large B cell lymphoma 
  PI: Elizabeth Lihua Budde, M.D., Ph.D.
• Multiple myeloma — NCT03168438 
  NY-ESO-1c²⁵⁹T alone and in combination with pembrolizumab for multiple myeloma 
  PI: Maung Myo Htut, M.D.
• Myeloma — IRB #20059 
  A dose-escalation study to evaluate the safety and clinical activity of PBCAR269A in study participants with relapsed/refractory multiple myeloma 
  PI: Maung Myo Htut, M.D.
• NHL/ALL — IRB #18388 
  Phase 1/2a, open-label, dose-escalation/expansion, parallel assignment study to evaluate the safety and clinical activity of PBCAR0191 in subjects with relapsed/refractory Non-Hodgkin lymphoma and B cell acute lymphoblastic leukemia 
  PI: Anthony Stein, M.D.
• NHL/CLL/SLL — IRB #20075
  A Phase 1/2a, open-label, dose-escalation/expansion, parallel assignment study to evaluate the safety and clinical activity of PBCAR20A in study participants with relapsed/refractory Non-Hodgkin lymphoma or chronic lymphocytic leukemia or small lymphocytic lymphoma
  PI: Geoffrey Shouse, D.O., Ph.D.
• Peds ALL — IRB #19376 
  A Phase II trial of tisagenlecleucel in first-line high-risk pediatric and young adult patients with B cell acute lymphoblastic leukemia who are minimal residual disease positive at the end of consolidation therapy 
  PI: Anna Pawlowska, M.D.
• Peds ALL and DLBCL — IRB #19396 
  Managed access program to provide access to CTL019, for ALL or DLBCL patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release 
  PI: Elizabeth Lihua Budde, M.D., Ph.D.
• BPDCN/AML/MDS — IRB #19092 
  A Phase 1/2, open-label, multicenter trial to assess the safety and efficacy of MB-102 in patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm, acute myeloid leukemia, and high-risk myelodysplastic syndrome 
  PI: Elizabeth Lihua Budde, M.D., Ph.D.

Preclinical Research