Actively Recruiting
A Phase I Trial of A-CAR032 in Participants With mCRPC
Led by Shanghai AbelZeta Ltd. · Updated on 2026-01-15
27
Participants Needed
5
Research Sites
834 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 disease progression despite castration by orchiectomy or ongoing luteinising hormone-releasing hormone analogues.
- Measurable PSA of 1 ng/mL or higher.
- Evidence of disease progression within 6 months prior to screening.
- Previous treatment with an androgen receptor pathway inhibitor (ARPI) such as abiraterone, enzalutamide, apalutamide, darolutamide, or rezvilutamide.
- Considered ineligible for standard treatment by the investigator.
- Minimum life expectancy greater than 12 weeks before apheresis.
- Adequate organ and marrow function.
- Consent to provide tumor material for biomarker assessment.
- Use of contraception consistent with local regulations.
- Voluntary participation with signed informed consent.
You will not qualify if you...
- Known life-threatening allergies or intolerance to CAR-T product or its components.
- Contraindications to lymphodepleting agents like fludarabine or cyclophosphamide.
- History of other primary malignancies except certain treated cancers with no active disease for 3 years.
- Known brain metastases.
- History of splenectomy or organ transplantation.
- Previous treatment with any CAR-T therapy or STEAP2-targeting therapy.
- Active or past autoimmune or inflammatory disorders.
- Symptomatic or uncontrolled cardiac arrhythmias.
- Active infections including hepatitis B, hepatitis C, CMV, syphilis, or HIV.
- Central nervous system diseases.
- Active bleeding or bleeding disorders.
- Plans to father a child during the study.
- Alcohol or drug abuse.
- Use of full-dose oral or parenteral anticoagulants or thrombolytics for therapeutic purposes from consent to 28 days post-infusion.
- Recent major surgery or unhealed wounds within 4 weeks prior to apheresis.
- Recent use of systemic steroids or immunomodulators within 5 half-lives or 7 days before apheresis.
- Receipt of last anticancer therapy within 5 half-lives or 21 days before apheresis.
- Radiotherapy within 4 weeks prior to apheresis, except limited bone marrow exposure or certain local treatments within longer time frames.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Not Yet Recruiting
2
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, China, 430100
Not Yet Recruiting
3
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221006
Not Yet Recruiting
4
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310013
Actively Recruiting
5
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
Research Team
W
Weijia Pang
CONTACT
N
Nicole Shen
CONTACT
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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