Moffitt Researchers Investigating CAR T Therapy Feasibility in Metastatic Castration-resistant Prostate Cancer

Chimeric antigen receptor T-cell therapy, or CAR T, has made a big impact on the treatment of certain blood cancers, allowing patients with relapsed/refractory disease to live longer, healthier lives. However, in clinical studies, cellular therapy has not been as successful for patients with solid tumors, due in part to the lack of tumor targets not expressed in vital tissues.

Most CAR-T trials in solid tumors used alpha beta T cells. Moffitt researchers aim to improve the efficacy and safety of CAR-T therapy with infusion of freshly produced gamma delta enriched CAR-T cells. Pre-clinical studies also showed synergy of Moffitt’s CAR-T product that targets prostate cancer stem cell antigen (PSCA) with the standard of care bone modifying treatment, zoledronic acid.

Jingsong Zhang, MD, PhD, a medical oncologist in the Department of Genitourinary Oncology at Moffitt, is leading an Investigator Initiated Trial (IIT), a phase I clinical trial of an infusion of autologous gamma delta T cells genetically engineered with a chimeric receptor to target the prostate stem cell antigen in patients with metastatic castration-resistant prostate cancer.   The primary objective is to assess the safety and tolerability of autologous PSCA-enriched CAR T cell product in patients with mCRPC and to identify the recommended phase 2 dose (RP2D).  This trial is currently open for accrual and is only available at Moffitt.

Inclusion criteria:

• For patients who are on zoledronic acid a booster dose of zoledronic acid is required if the last dose of zoledronic acid is >4 weeks before lymphodepletion chemo. If a patient is receiving denosumab, the next dose of denosumab needs to be changed to zoledronic acid and he needs to receive at least 1 dose of zoledronic acid before lymphodepletion chemotherapy. If a patient is not on zoledronic acid or denosumab, he needs to receive at least 2 doses of every 4 weeks of zoledronic acid before lymphodepletion chemotherapy. Zoledronic acid is recommended not to be resumed before week 8. After week 8, the resumption of zoledronic acid and the subsequent zoledronic acid treatment will be at the discretion of the treating physician.
• No anticancer therapy (chemotherapy, biological therapy, radiation, or immunotherapy) in the 3 weeks before the T cell infusion (and all hematologic effects have resolved). No prior treatment with Radium 223 or Puvicto within 3 months of T cell infusion. No prior immunotherapy with checkpoint blockade (e.g., PD-1 inhibitor, PDL1 inhibitor, or CTL4- antagonist or similar agent) in the 6 months before the T cell infusion (and all clinically significant related side effects must be resolved).
• ECOG performance status greater than or equal to 2 (or Karnofsky Performance Status greater than or equal to 70%).

More Trial Details

If a patient has a known dental issue like osteonecrosis of the jaw that excludes the use of zoledronic acid, this will disqualify them from participating in this trial.

If you have a patient with metastatic castration-resistant prostate cancer who may be eligible to participate in the trial, please call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.