NCT07344311

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Shanghai AbelZeta Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consists of two parts: Part 1-Dose Escalation and Part 2-Dose Expansion. Participants in the study will proceed through screening, apheresis, bridging therapy (if appropriate), lymphodepletion, CAR-T cell infusion, and subsequent follow-up (including Stage 1, 2 and 3).

Conditions

• Prostate Cancer
• Metastatic Castration-Resistant Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	dnTGFβRII-armoured STEAP2-targeted autologous CAR T-Cell Injection	dnTGFβRII-armoured STEAP2-targeted autologous CAR T-Cell Injection.single infusion intravenously.

Timeline

• Start date: 2026-01-31
• Primary completion: 2027-01-31
• Completion: 2042-01-31
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

5 sites across 1 country: China