A Phase I Trial of A-CAR032 in Participants With mCRPC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorShanghai AbelZeta Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Participant must be 18 years or older at the time of signing the ICF. Type of Participant and Disease Characteristics
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
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- dnTGFβRII-armoured STEAP2-targeted autologous CAR T-Cell Injection
Treatment groups
27 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov