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CD19-redirected Autologous Cells (CAR-CD19 T cells)

Autologous T Cells with a Chimeric Antigen Receptor in Patients with CD19-positive Malignant B Cell Leukemia and Lymphoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-RPC-16009896
Enrollment
Unknown
Registered
2016-11-17
Start date
2016-10-20
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CD19+ Malignant Leukemia and Lymphoma

Interventions

Case series:N/A

Sponsors

Renji Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Subjects with documented CD19-positive malignant B cell leukemia and lymphoma. 1. Patients aged between 18 ~ 65 with malignant B cell leukemia and lymphoma; 2. CD19-positive B cell leukemia or lymphoma; 3. Expected survival > 12 weeks; 4. ECOG scores 0-1, or KPS scores > 80; 5. Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis. 6. WBC = 2.5×10^9/L; LY = 0.7×109/L; LY% = 15%; 7. Creatinine = 2.0 mg/dL (176.8 µmol/L); 8. ALT/AST = 2.5 ULN; 9. Bilirubin = 2.0 mg/dL (34.2 µmol/L); 10. Prothrombin Time (PT): International Normalized Ratio (INR) < 1.7, or PT is at most 4 s longer than normal value. All tests results should comply with the above criteria. No continuing supportive care is received.

Exclusion criteria

Exclusion criteria: 1. CD19-negative B cell leukemia or lymphoma; 2. Feasibility assessment during screening demonstrates 300 mg/d; Clopidogrel, dose > 75 mg/d); 17. Any radiotherapy conducted within 4 weeks prior to blood sampling.

Design outcomes

Primary

MeasureTime frame
Cytokinetics;Safety & tolerance;

Countries

China

Contacts

Public ContactFangyuan Chen

Renji Hospital, Shanghai Jiaotong University School of Medicine

chenfangyuan62@163.com+86 021 68383143

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026