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Recruiting
NCT03125577
Combination CAR-T Cell Therapy Targeting Hematological Malignancies
Conditions: B-cell Malignancies
Sex: All
Ages: 6 Months – 75 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 100
Sponsor: Shenzhen Geno-Immune Medical Institute
Location: Shenzhen Geno-immune Medical Institute Shenzhen Guangdong
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 Criteria
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.
Source: ClinicalTrials.gov (NCT03125577). StuddyBuddy aggregates publicly available trial information.