AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

a study on Metastatic Castration-Resistant Prostate Cancer Prostate Cancer

Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

This is a multi-center, open-label Phase 1/2 trial evaluating the safety and efficacy of AB-3028 in subjects with metastatic castration resistant prostate cancer (mCRPC).

Official Title

An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-3028 in Patients With Castration Resistant Prostate Cancer (CRPC)

Details

This study is intended for subjects diagnosed with metastatic castration-resistant prostate cancer (mCRPC) and whose disease progressed after treatment with an androgen receptor pathway inhibitor (ARPI). The purpose of this study is to test the safety and efficacy of AB-3028 cells in subjects with metastatic castration-resistant prostate cancer. This treatment has not been approved by the Food and Drug Administration.

The goal of the Phase I portion of this study is to evaluate safety profile of AB-3028 and to determine the maximum tolerated dose or recommended phase 2 dose of AB-3028. The Phase 2 portion of the study will investigate the efficacy of AB-3028. 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 subject and will have a DNA cassette put in them that makes them able to recognize a priming antigen as well as Prostate-Specific Membrane Antigen (PSMA), two proteins found on prostate cancer 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-3028 cells are given as a single intravenous infusion.

After completion of study treatment, subjects 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.

Keywords

Metastatic Castration Resistant Prostate Cancer (mCRPC), prostate cancer, metastatic, Programmable circuit T cell, CRPC, AB-3028, autologous Cell Therapy, Cell Therapy, CAR T, castration resistant, Prostatic Neoplasms, Neoplasm Metastasis

Eligibility

You can join if…

Open to males ages 18 years and up

  1. At least 18 years of age at time of signing informed consent form.

  2. Histologically confirmed adenocarcinoma of the prostate, meeting all of the following criteria:

    • Documented progressive metastatic castration-resistant prostate cancer (mCRPC) based on PCWG3 criteria.

  3. Prior prostate cancer treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy.

    • PSMA+ by PSMA PET.

    • Measurable disease by RECIST 1.1 criteria, or evaluable disease via measurable PSA (≥ 1 ng/mL) per PCWG3 criteria.
  4. Adequate organ functions.

You CAN'T join if...

  1. Any prior systemic therapy for CRPC within 14 days prior to scheduled protocol required leukapheresis.
  2. Central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.
  3. Unwillingness to participate in an extended safety monitoring period.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • USC Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arsenal Biosciences, Inc.
ID
NCT07285694
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 190 study participants
Last Updated
Contact us about this trial