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.
The study consists of two parts: Part 1-Dose Escalation and Part 2-Dose Expansion. Participants in the study will proceed through screening, apheresis, bridging therapy (if appropriate), lymphodepletion, CAR-T cell infusion, and subsequent follow-up (including Stage 1, 2 and 3).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
dnTGFβRII-armoured STEAP2-targeted autologous CAR T-Cell Injection.single infusion intravenously.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing GoBroad Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGTongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, China
Dose Escalation (Part 1):Safety
Incidence of AEs/SAEs
Time frame: From ICF signature until 15 years post A-CAR032 infusion
Dose Escalation (Part 1):Safety
Occurrence of DLTs/DLT-like events
Time frame: Throughout the 28 days post A-CAR032 infusion
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 infusion
Dose Expansion (Part 2):Safety
Incidence of AEs/SAEs
Time frame: From ICF signature until 15 years post A-CAR032 infusion
Dose Expansion (Part 2):Safety
Incidence of DLT-like events
Time frame: Throughout the 28 days post A-CAR032 infusion
Dose Expansion (Part 2):Safety
Changes from baseline in laboratory parameters, vital signs, and ECGs
Time frame: From ICF signature until 12 months post A-CAR032 infusion
Dose Escalation (Part 1) and Dose Expansion (Part 2):Efficacy
PSA-related response
Time frame: From ICF signature until 12 months post A-CAR032 infusion
Dose Escalation (Part 1) and Dose Expansion (Part 2):Efficacy
Radiological response
Time frame: From ICF signature until 12 months post A-CAR032 infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGThe First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGDose Escalation (Part 1) and Dose Expansion (Part 2):Efficacy
rPFS
Time frame: From ICF signature until 12 months post A-CAR032 infusion
Dose Escalation (Part 1) and Dose Expansion (Part 2):Efficacy
OS
Time frame: From ICF signature until 15 years post A-CAR032 infusion
Dose Escalation (Part 1) and Dose Expansion (Part 2):Efficacy
Time from A-CAR032 infusion to first SSRE
Time frame: From A-CAR032 infusion until 12 months post A-CAR032 infusion
Dose Escalation (Part 1) and Dose Expansion (Part 2):Pharmacokinetics
CK profile of A-CAR032
Time frame: From ICF signature until 15 years post A-CAR032 infusion