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

NCT07344311 | Recruiting Phase 1 DMC

• 1 other identifier: 1332-046
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Prostate Cancer; Metastatic Castration-Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (6)

• Dose Escalation (Part 1)：Safety

  Incidence of AEs/SAEs

  From ICF signature until 15 years post A-CAR032 infusion

• Dose Escalation (Part 1)：Safety

  Occurrence of DLTs/DLT-like events

  Throughout the 28 days post A-CAR032 infusion

• Dose Escalation (Part 1)：Safety

  Changes from baseline in laboratory parameters, vital signs, and ECGs

  From ICF signature until 12 months post A-CAR032 infusion

• Dose Expansion (Part 2)：Safety

  Incidence of AEs/SAEs

  From ICF signature until 15 years post A-CAR032 infusion

• Dose Expansion (Part 2)：Safety

  Incidence of DLT-like events

  Throughout the 28 days post A-CAR032 infusion

• Dose Expansion (Part 2)：Safety

  Changes from baseline in laboratory parameters, vital signs, and ECGs

  From ICF signature until 12 months post A-CAR032 infusion

Secondary Outcomes (6)

• Dose Escalation (Part 1) and Dose Expansion (Part 2)：Efficacy

  From ICF signature until 12 months post A-CAR032 infusion

• Dose Escalation (Part 1) and Dose Expansion (Part 2)：Efficacy

  From ICF signature until 12 months post A-CAR032 infusion

• Dose Escalation (Part 1) and Dose Expansion (Part 2)：Efficacy

  From ICF signature until 12 months post A-CAR032 infusion

• Dose Escalation (Part 1) and Dose Expansion (Part 2)：Efficacy

  From ICF signature until 15 years post A-CAR032 infusion

• Dose Escalation (Part 1) and Dose Expansion (Part 2)：Efficacy

  From A-CAR032 infusion until 12 months post A-CAR032 infusion

Study Arms (1)

A-CAR032

EXPERIMENTAL

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.

Biological: dnTGFβRII-armoured STEAP2-targeted autologous CAR T-Cell Injection

Interventions

dnTGFβRII-armoured STEAP2-targeted autologous CAR T-Cell Injection BIOLOGICAL

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

A-CAR032

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 18 years or older at the time of signing the ICF. Type of Participant and Disease Characteristics
• Participants with:
• A histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate without known neuroendocrine differentiation or small cell features.
• Castration-resistant prostate cancer as defined by disease progression despite castration by orchiectomy or ongoing luteinising hormone-releasing hormone analogue. Participants receiving medical castration therapy with gonadotropin-releasing hormone analogues should continue this treatment during the study.
• Measurable PSA≥1 ng/mL AND
• Evidence of progression within 6 months prior to screening
• Participant has previously received an ARPI (ie, abiraterone, enzalutamide, apalutamide, darolutamide, rezvilutamide) whether before or in the metastatic castration-resistant setting, and in the judgment of the investigator, be ineligible for standard treatment.
• Minimum life expectancy of \> 12 weeks prior to apheresis in the opinion of the investigator.
• Adequate organ and marrow function
• Consent and provision of tumour material to assess STEAP2 expression and other correlative biomarkers retrospectively with pre- and post-treatment biopsies.
• Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• The participant voluntarily participates in the study, and the individual or their legal guardian signs the ICF.

You may not qualify if:

• Known life-threatening allergies, hypersensitivity, or intolerance to the CAR-T product or its excipients, including dimethyl sulfoxide (DMSO).
• Contraindication to lymphodepleting agents, including fludarabine and/or cyclophosphamide.
• History of another primary malignancy except for:
• Malignancy treated with curative intent and with no known active disease within 3 years before the apheresis and of low potential risk for recurrence.
• Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease.
• Adequately treated carcinoma in situ without evidence of disease.
• Participants with known brain metastases.
• History of splenectomy or organ transplantation.
• Prior treatment with:
• Any CAR-T therapy. OR
• Any therapy that is targeting STEAP2.
• Active or prior documented autoimmune or inflammatory disorders
• Cardiac arrhythmias which are symptomatic or require treatment unless controlled by pacemaker (judged by investigator); symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia.
• Active infection, including:
• HBV infection is defined as hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive and HBV DNA detectable.

Sponsors & Collaborators

• Shanghai AbelZeta Ltd.: lead

Study Sites (5)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

NOT YET RECRUITING

Tongji Hospital, Tongji Medical College of HUST

Wuhan, Hubei, 430100, China

NOT YET RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

NOT YET RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310013, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Weijia Pang

CONTACT

+86-21-54069990; weijia.pang@abelzeta.com

Nicole Shen

CONTACT

+86-21-54069993; yinghua.shen@abelzeta.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2042
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)