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Recruiting
NCT04429438
Multi-CAR-T Cells Targeting B Cell Lymphomas
Conditions: B Cell Lymphoma (BCL)
Sex: All
Ages: 6 Months – 75 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 11
Sponsor: Shenzhen Geno-Immune Medical Institute
Location: Shenzhen Geno-Immune Medical Institute Shenzhen Guangdong
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 Criteria
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.
Source: ClinicalTrials.gov (NCT04429438). StuddyBuddy aggregates publicly available trial information.