First test of A-CAR032 CAR T-cell therapy in advanced prostate cancer

Trial details

Who runs it

Shanghai AbelZeta Ltd.

Trial code

NCT07344311

Record updated

16 October 2026

Original description

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.Read full original descriptionShow less

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)

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.

Inclusion: 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.

Exclusion: 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; Prior treatment with:; Any CAR-T therapy. OR; Any therapy that is targeting STEAP2; Active or prior documented autoimmune or inflammatory disorders; Patients with alcohol or drug abuse; Received the following:; Major surgery within 4 weeks prior to apheresis or existence of unhealed wound, or planned major surgery within 4 weeks of the study treatment administration; Steroids (except inhaled steroids) or other immunomodulators (including interleukins, interferons, and thymosins) of systemic therapeutic dose, and systemic corticosteroids at doses exceeding 10 mg/day of prednisone or equivalent within 5 half-lives or 7 days (whichever is shorter) prior to apheresis; Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy targeted therapy, biologic therapy, tumour embolisation, or monoclonal antibodies, investigational product) within 5 half-lives or ≤ 21 days (whichever is shorter) prior to apheresis; Radiotherapy within 4 weeks of apheresis (However, if the radiation portal covered ≤ 5% of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy); or within 6 months or 5 half-lives (whichever is longer) if local radioactive particle implantation was performed; Known life-threatening allergies, hypersensitivity, or intolerance to the CAR-T product or its excipients, including dimethyl sulfoxide (DMSO); History of splenectomy or organ transplantation; 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; HCV infection is defined as HCV antibody positive and HCV RNA positive; CMV infection is defined as CMV DNA detectable; Syphilis infection is defined as syphilis antigen and antibody positive; HIV infection is defined as HIV 1/2 antibody positive; Other persistent or active infections requiring systemic treatment (prophylactic use of anti-infective drugs is allowed); Patients with central nervous system (CNS) diseases:; Obvious risk or tendency of bleeding or active bleeding (eg, clinically significant hemoptysis, tumour bleeding, history of von Willebrand disease or hemophilia etc.); Contraindication to lymphodepleting agents, including fludarabine and/or cyclophosphamide; Participants with known brain metastases; Plans to father a child during the study period; Participants may not receive full-dose long acting oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose from the time of informed consent to 28 days post infusion of A-CAR032. Use of short acting direct oral anticoagulants for therapeutic and prophylactic purposes are permitted.

ClinicalTrials.gov NCT07344311