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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
dnTGFβRII-armoured STEAP2-targeted autologous CAR T-Cell Injection
Biological/VaccinednTGFβRII-armoured STEAP2-targeted autologous CAR T-Cell Injection.single infusion intravenously.
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: A-CAR032Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Escalation (Part 1)：Safety
Incidence of AEs/SAEs
Time frame
From ICF signature until 15 years post A-CAR032 infusion2
Dose Escalation (Part 1)：Safety
Occurrence of DLTs/DLT-like events
Time frame
Throughout the 28 days post A-CAR032 infusion3
Dose Escalation (Part 1)：Safety
Changes from baseline in laboratory parameters, vital signs, and ECGs
Time frame
From ICF signature until 12 months post A-CAR032 infusion4
Dose Expansion (Part 2)：Safety
Incidence of AEs/SAEs
Time frame
From ICF signature until 15 years post A-CAR032 infusionSecondary outcomes
1
Dose Escalation (Part 1) and Dose Expansion (Part 2)：Efficacy
PSA-related response
Time frame
From ICF signature until 12 months post A-CAR032 infusion2
Dose Escalation (Part 1) and Dose Expansion (Part 2)：Efficacy
Radiological response
Time frame
From ICF signature until 12 months post A-CAR032 infusion3
Dose Escalation (Part 1) and Dose Expansion (Part 2)：Efficacy
rPFS
Time frame
From ICF signature until 12 months post A-CAR032 infusion4
Dose Escalation (Part 1) and Dose Expansion (Part 2)：Efficacy
OS
Time frame
From ICF signature until 15 years post A-CAR032 infusionSponsors and contacts
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Source ClinicalTrials.gov