Actively Recruiting
First Time-in-Human Phase I Trial to Evaluate Safety and Efficacy of A-CAR032 in Adults With Metastatic Castration-Resistant Prostate Cancer
Led by Shanghai AbelZeta Ltd. · Updated on 2026-06-01
27
Participants Needed
5
Research Sites
782 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating A-CAR032, a new CAR-T cell therapy, in adults with metastatic castration-resistant prostate cancer (mCRPC) who have previously progressed after androgen receptor pathway inhibitor (ARPI) treatment and are not eligible for standard treatment. This Phase I trial is the first time this treatment is being tested in humans and aims to assess its safety, antitumor activity, pharmacodynamics, biomarkers, immunogenicity, and feasibility. The study has two parts: Part 1 involves dose escalation to find the maximum tolerated or recommended dose, using three planned dose levels with 3 to 9 participants each. Part 2 involves dose expansion at the recommended dose to further evaluate safety and biological activity with about 12 participants. The treatment includes screening, apheresis (collection of cells), possible bridging therapy, lymphodepletion, and a single intravenous infusion of the CAR-T cells, followed by detailed follow-up in several stages. Participants will undergo multiple assessments including safety monitoring from consent until up to 15 years after infusion, evaluations of efficacy and pharmacokinetics up to 12 months or longer, and collection of tumor material for biomarker analysis. Safety reviews occur throughout the first 28 days post-infusion and over extended periods. The trial includes long-term follow-up to monitor outcomes and potential effects of the therapy, lasting up to 15 years after treatment.
CONDITIONS
Brief Title
A Phase I Trial of A-CAR032 in Participants With mCRPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years or older at the time of signing the informed consent form.
- Histologically confirmed metastatic adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
- Castration-resistant prostate cancer with progression despite surgical or medical castration.
- Measurable PSA of 1 ng/mL or higher.
- Evidence of disease progression within 6 months prior to screening.
- Prior treatment with an androgen receptor pathway inhibitor (ARPI).
- Minimum life expectancy of more than 12 weeks before apheresis.
- Adequate organ and marrow function.
- Consent to provide tumor material for biomarker analysis.
- Use contraceptive methods according to local regulations.
- Voluntary participation with signed informed consent form.
You will not qualify if you...
- Known life-threatening allergies or intolerance to the CAR-T product or its components.
- Contraindications to lymphodepleting agents like fludarabine or cyclophosphamide.
- History of another primary cancer except certain treated cancers with no active disease.
- Known brain metastases.
- History of splenectomy or organ transplantation.
- Prior treatment with any CAR-T therapy or STEAP2-targeting therapy.
- Active or prior autoimmune or inflammatory disorders.
- Certain cardiac arrhythmias unless controlled.
- Active infections including hepatitis B, hepatitis C, CMV, syphilis, HIV, or other requiring treatment.
- Central nervous system diseases.
- Active or risk of bleeding disorders.
- Plans to father a child during the study.
- Alcohol or drug abuse.
- Use of full-dose anticoagulants for therapeutic reasons from consent to 28 days post infusion.
- Recent major surgery, unhealed wounds, or planned major surgery near treatment time.
- Recent use of systemic steroids or immunomodulators above specified doses before apheresis.
- Recent anticancer therapy within specified washout periods.
- Recent radiotherapy within specified time limits unless meeting certain criteria.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo apheresis to collect cells needed for CAR T-cell manufacturing.
1 visit (in-person)
Duration - Variable duration before lymphodepletion
Participants may receive bridging therapy to control disease while CAR T-cells are being prepared, if appropriate.
Visit schedule varies depending on therapy
Duration - Several days
Participants receive lymphodepleting chemotherapy prior to CAR T-cell infusion to prepare the body for treatment.
Multiple visits over lymphodepletion period
Duration - Single day infusion
Participants receive a single intravenous infusion of the A-CAR032 CAR T-cell therapy.
1 infusion visit (in-person)
Duration - Up to 15 years post-infusion
Participants are monitored for safety, efficacy, and biological activity after the CAR T-cell infusion, including long-term follow-up up to 15 years.
Visits scheduled frequently initially, then less frequently during long-term monitoring
Trial Site Locations
Total: 5 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102200
Not Yet Recruiting
3
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, China, 430100
Actively Recruiting
4
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221006
Actively Recruiting
5
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310013
Actively Recruiting
Research Team
A
Andy Zou
N
Nicole Shen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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