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Multi-CAR-T Cells Targeting B Cell Lymphomas

RECRUITINGPhase 1/2Sponsored by Shenzhen Geno-Immune Medical Institute
Actively Recruiting
PhasePhase 1/2
SponsorShenzhen Geno-Immune Medical Institute
Started2026-06-01
Est. completion2029-12-31
Eligibility
Age6 Months – 75 Years
Healthy vol.Accepted

Summary

This study aims to evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting B cell surface molecules including CD19 and alternative CARTs as booster and consolidation treatment for patients with highly resistant B cell lymphomas, including primary mediastinal B cell lymphoma (PMBCL) and BCL involving central nervous system (CNS-BCL). Clinical response and development of a simplified and standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

Eligibility

Age: 6 Months – 75 YearsHealthy volunteers accepted
Inclusion Criteria:

1. Age older than 6 months.
2. Primary B cell lymphoma surface expression of CD19 and/or CD22/CD70/PSMA/ CD13/CD79b/GD2 molecules.
3. The KPS score over 80 points, and survival time is more than 1 month.
4. Greater than Hgb 80 g/L.
5. No contraindications to blood cell collection.

Exclusion Criteria:

1. Accompanied with other active diseases, and difficult to assess response after treatment.
2. Bacterial, fungal, or viral infection, unable to control.
3. Living with HIV.
4. Active HBV and HCV infection.
5. Pregnant and nursing mothers.6. under systemic steroid treatment within a week of the treatment.

7\. Prior failed CAR-T treatment.

Conditions2

B Cell Lymphoma (BCL)Cancer

Interventions1

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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