PSMA/CD70 Bi-specific CAR-T Cell Therapy
ConditionCancer Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-75
SponsorShenzhen Geno-Immune Medical Institute
About this trial
The purpose of this study is to assess the feasibility, safety and efficacy of anti-PSMA/CD70 bi-specific CAR-T cell therapy in patients with CD70 and PSMA positive malignancies. Another goal of the study is to learn more about the function of the PSMA/CD70 bi-specific CAR-T cells and their persistency in patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with tumor cells have received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent.
The expression status of CD70 or PSMA antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by CD70 and 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 4 weeks following completion of therapy are eligible.
Previous treatment with other genetically engineered CD70 or PSMA-specific CAR T cells.
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
bi-4SCAR PSMA/CD70 T cells
Biological/VaccineInfusion of bi-4SCAR PSMA/CD70 T cells at 10\^6 cells/kg body weight via IV
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: bi-4SCAR-PSMA/CD70 T Cell Therapy for CD70 and/or PSMA positive cancerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients with adverse events.
Determine the toxicity profile the bi-4SCAR PSMA/CD70 cells with Common Toxicity Criteria for Adverse Effects version 4.0
Time frame
6 monthsSecondary outcomes
1
Tumor remission response evaluation
Objective complete response (CR) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time frame
1 year2
Tumor remission response evaluation
Objective partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time frame
1 year3
The expansion of bi-4SCAR PSMA/CD70 T cells
Scale of CAR copies (for efficacy)
Time frame
1 year4
The persistence of bi-4SCAR PSMA/CD70 T cells
Scale of tumor burden (for efficacy)
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov