BridgeMD
New treatment option for Prostate Cancer
Official title A Phase I Trial of A-CAR032 in Participants With mCRPC
ClinicalTrials.gov ID: NCT07344311
What this study is testing
What is dnTGFβRII-armoured STEAP2-targeted autologous CAR T-Cell Injection?
dnTGFβRII-armoured STEAP2-targeted autologous CAR T-Cell Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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...
- Measurable PSA≥1 ng/mL AND
You likely can't join 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.
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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...
- 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.).
- Plans to father a child during the study period.
- Patients with alcohol or drug abuse.
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Wuhan, Hubei, China
- Xuzhou, Jiangsu, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Wuhan, Hubei, China; Xuzhou, Jiangsu, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.