← Back to all trials
Not Yet Recruiting
NCT05995015
4SCAR19U T Cells Targeting B Cell Malignancies
Conditions: B Cell Malignancies
Sex: All
Ages: 6 Months – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: Shenzhen Geno-Immune Medical Institute
Location: Shenzhen Geno-Immune Medical Institute Shenzhen Guangdong
Summary
The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling patients from multiple clinical centers.
Eligibility Criteria
Inclusion Criteria:
1. Age older than 6 months.
2. Primary B cell surface expression of CD19.
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 or 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 (NCT05995015). StuddyBuddy aggregates publicly available trial information.