This is a multi-center, open-label phase 1/2 trial evaluating the safety and efficacy of AB-2100 cell product. The study may enroll approximately 60 patients in phase 1 and approximately 70 patients in phase 2.
This study is intended for the patients who have been diagnosed with clear-cell renal cell carcinoma that either came back or did not improve after treatment with a checkpoint inhibitor and a VEGF inhibitor. The purpose of this study is to test the safety and efficacy of AB-2100 cells in patients with renal cell carcinoma. This treatment has not been approved by the Food and Drug Administration. The goal of this study is to determine the maximum tolerated dose of the AB-2100 cells. T cells are part of the immune system that protect the body from infection and may help fight cancer. The T cells given in this study will come from the patient and will have a genetic circuit/logic gate put in them that makes them able to recognize prostate-specific membrane antigen (PSMA) and carbonic anhydrase 9 (CA9), 2 proteins found on tumor cells. These logic-gated T cells may help the body's immune system identify and kill cancer cells while sparing normal healthy tissues from toxicity. The AB-2100 cells are given as a single intravenous infusion. Patients may be assigned to receive conditioning chemotherapy prior to the infusion After completion of study treatment, patients are followed with serial measurements of safety, tolerability and response. This is a research study to obtain new information that may help people in the future.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
autologous T cell therapy
Mayo Clinic Hospital
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Iowa and Holden Comprehensive Cancer Center
Phase 1 (Dose escalation): incidence of adverse events
Defined as dose-limiting toxicities based on a 3+3 dose escalation study design
Time frame: From AB-2100 infusion up to 21 days post infusion
Phase 2 (Cohort expansion): Objective response rate (ORR)
ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to RECIST v1.1
Time frame: From AB-2100 infusion up to 24 months post-infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Iowa City, Iowa, United States
Dana Farber Cancer Institue
Boston, Massachusetts, United States
Perlmutter Cancer Center - NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute - Univ of Utah Health
Salt Lake City, Utah, United States