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Combination CAR-T Cell Therapy Targeting Hematological Malignancies

RECRUITINGPhase 1/2Sponsored by Shenzhen Geno-Immune Medical Institute
Actively Recruiting
PhasePhase 1/2
SponsorShenzhen Geno-Immune Medical Institute
Started2025-08-01
Est. completion2028-12-31
Eligibility
Age6 Months – 75 Years
Healthy vol.Accepted

Summary

The study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) and CD20 (4SCAR20), CD22 (4SCAR22), CD30 (4SCAR30), CD38 (4SCAR38), CD70 (4SCAR70) or CD123 (4SCAR123) for patients with B cell malignancies. Clinical response and development of a 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. malignant B cell surface expression of CD19/CD20/CD22/CD30/CD38/CD70/CD123 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, the treatment is difficult to assess patient response.
2. bacteria, fungus, or virus 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 MalignanciesCancer

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