RecruitingPhase 1NCT07344311

A Phase I Trial of A-CAR032 in Participants With mCRPC

First Time-in-Human (FTiH), Phase I Trial to Evaluate the Safety, Cellular Kinetics, and Efficacy of A-CAR032, in Adult Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)


Sponsor

Shanghai AbelZeta Ltd.

Enrollment

27 participants

Start Date

Jan 13, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This FTiH, single-arm, open-label, investigator-initiated Phase I trial will evaluate the safety, antitumour activity, CK/pharmacodynamics (PD), biomarkers, immunogenicity, and feasibility of A-CAR032 in adult participants with mCRPC, who have previously progressed after ARPI treatment of prostate cancer (whether before or in the metastatic castration-resistant setting) and, in the judgment of the investigator, are ineligible for standard treatment.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase trial testing a new type of immune cell therapy called A-CAR032 — engineered immune cells designed to attack prostate cancer cells — for men with advanced prostate cancer that no longer responds to hormone therapy. **You may be eligible if...** - You are 18 or older with confirmed metastatic castration-resistant prostate cancer (prostate cancer that spread and stopped responding to hormone treatment) - Your cancer has progressed within the past 6 months - You have previously tried at least one hormone-blocking drug (like enzalutamide or abiraterone) - Your PSA (prostate cancer marker) is 1 ng/mL or higher - Your organs are functioning well enough for treatment **You may NOT be eligible if...** - You have cancer in your brain - You have had a previous CAR-T cell therapy - You have active autoimmune disease or inflammatory conditions - You have an active infection including HIV, hepatitis B or C, or CMV - You have had major surgery in the past 4 weeks - You are currently on high-dose steroids or blood thinners Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALdnTGFβRII-armoured STEAP2-targeted autologous CAR T-Cell Injection

dnTGFβRII-armoured STEAP2-targeted autologous CAR T-Cell Injection.single infusion intravenously.


Locations(5)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China

Tongji Hospital, Tongji Medical College of HUST

Wuhan, Hubei, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07344311


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