Status:
UNKNOWN
CAR-T-19 Cells for Patients With CD19+ Relapse/Refractory B-ALL
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
CD19+ Relapse/Refractory B-ALL
Eligibility:
All Genders
Up to 25 years
Phase:
PHASE1
Brief Summary
This is a single-arm, open-label phase I study to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19 cells for patients with CD19+ relapse/refractory B-ALL under the age of 25.
Detailed Description
B-cell acute lymphoblastic leukemia (B-ALL) accounting for 85% of all ALL cases, is a common hematological malignancy in children and adults. CD19 is a widely expressed antigen in both normal B cells ...
Eligibility Criteria
Inclusion
- Patients with relapse/refractory B-ALL.
- Tumor cells from bone marrow or peripheral blood are measured CD19+ with 3 months before enrollment.
- Karnofsky Score ≥ 70 or Lansky Score ≥ 50.
- Patients who have a life expectancy of at least 12 weeks.
- Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures.
Exclusion
- Patients with extramedullary relapse (EMR).
- Patients with genetic diseases, Burkitt lymphoma and leukemia or other malignancies.
- Patients positive for any of the following: HbsAg, HBV-DNA, HCV-Ab, HCV-RNA, HIV-Ab, TP-Ab, EBV-DNA or CMV-DNA.
- Patients with other uncontrolled infection.
- Patients who received anti-CD19 / anti-CD3 therapy, or any other anti-CD19 therapy.
- Patients with active Grade II-IV GVHD within 3 months prior to screening.
- Tumor cells are detected in cerebrospinal fluid.
- Patients who received HSCT within 3 months prior to screening.
- Anticipated other clinical trials within 4 weeks before this trial
- Pregnant or lactating women.
- Any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled.
Key Trial Info
Start Date :
February 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 16 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05270772
Start Date
February 25 2021
End Date
September 16 2024
Last Update
March 8 2022
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853