PSMA-specific CAR-T Cell Therapy
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-75
SponsorShenzhen Geno-Immune Medical Institute
About this trial
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of PSMA-specific CAR-T cell therapy in patients with PSMA positive tumor. Another goal of the study is to learn more about the function of the PSMA CAR-T cells and their persistency in the patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with tumors have received standard first-line therapy and have been judged to be non-respectable, metastatic, progressive or recurrent.
The expression status of PSMA antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by PMSA antibody staining results based on immunohistochemistry or flow cytometry analyses.
Body weight greater than or equal to 10 kg.
Age: ≥1 year and ≤ 75 years of age at the time of enrollment.
Disqualifiers
Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, or greater than grade 2 hematologic toxicity.
Untreatable central nervous system (CNS) metastasis: Patients with previous CNS tumor involvement that has been treated and is stable for at least 6 weeks following completion of therapy are eligible.
Previous treatment with other genetically engineered PSMA-specific CAR T cells or antibody therapy.
Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
Trial design
Design model
Single group
Treatments tested in this trial
4SCAR-PSMA T cells
Biological/VaccineInfusion of 4SCAR-PSMA T cells at 10\^6 cells/kg body weight via IV
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: 4SCAR-PSMA Cell Therapy for PSMA positive tumorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients with adverse events.
Determine the toxicity profile the 4SCAR-PSMA cells with Common Toxicity Criteria for Adverse Effects version 4.0
Time frame
3 yearSecondary outcomes
1
Anti-tumor effects
Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time frame
1 year2
The expansion and persistence of 4SCAR-PSMA T cells
Scale of CAR copies and tumor burden (for efficacy)
Time frame
1 year3
Survival time of the patients
The survival time of the patients treated with the 4SCAR-PSMA T cells, including progression free survival (PFS) and overall survival (OS) will be evaluated.
Time frame
3 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: