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

Sponsor
Shanghai AbelZeta Ltd.
Study ID
NCT07344311
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jan 15, 2026
Start date
Jan 13, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2042

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: A-CAR032
    Part 1 will follow an i3+3 design which is employed to explore the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE). Three dose levels of A-CAR032are initially planned with a minimum of 3 and maximum of 9 participants per dose level. The safety review committee (SRC) may suggest exploration of intermediate dose levels or additional higher or lower dose levels based on the available data, but will not exceed 3 times the current dose or 3 times the highest dose that has been determined safe by the SRC.Part 2 at the RDE of A-CAR032 will be initiated, if data support, to further evaluate the safety, CK, efficacy and potential biological activity of study intervention. Approximately 12 evaluable participants will be enrolled in Part 2.

Primary Outcome Measure

Dose Escalation (Part 1)：Safety [ Time Frame: From ICF signature until 15 years post A-CAR032 infusion ]

Central Contacts

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