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Recruiting NCT05437315

GD2/PSMA Bi-specific CAR-T Cell Therapy

Conditions: Solid Tumor

Sex: All
Ages: 1 Year – 75 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 60
Sponsor: Shenzhen Geno-Immune Medical Institute

Location: Shenzhen Geno-immune Medical Institute Shenzhen Guangdong

Summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of anti-GD2/PSMA bi-specific CAR-T cell therapy in patients with GD2 and PSMA positive tumor. Another goal of the study is to learn more about the function of the anti-GD2/PSMA bi-specific CAR-T cells and their persistency in patients.

Eligibility Criteria

Inclusion Criteria: 1. Patients with tumors have received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent. 2. The expression status of GD2 or PSMA antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and PMSA antibody staining results based on immunohistochemistry or flow cytometry analyses. 3. Body weight greater than or equal to 10 kg. 4. Age: ≥1 year and ≤ 75 years of age at the time of enrollment. 5. Life expectancy: at least 8 weeks. 6. Prior Therapy: There is no limit to the number of prior treatment regimens. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must be resolved to grade 2 or less. 7. Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection. 8. At least 7 days must have elapsed since the completion of therapy with a biologic agent, selected targeted agent or a metronomic non-myelosuppressive regimen. 9. At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody. 10. At least 1 week since any radiation therapy at the time of study entry. 11. Karnofsky/jansky score of 60% or greater. 12. Cardiac function: Left ventricular ejection fraction greater than or equal to 40/55 percent. 13. Pulse Ox greater than or equal to 90% on room air. 14. Liver function: defined as alanine transaminase (ALT) \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05437315). StuddyBuddy aggregates publicly available trial information.