CAR-T-19 Cells for Patients With CD19+ Relapse/Refractory B-ALL
NCT ID: NCT05270772
Last Updated: 2022-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
9 participants
INTERVENTIONAL
2021-02-25
2024-09-16
Brief Summary
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Detailed Description
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Primary endpoint is to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19. Secondary endpoints measure ORR, OS and others.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CAR-T-19 Cells
The patients with CD19+ relapse or refractory B-ALL will receive a single infusion of autologous CAR-T-19 cells, with the escalated dose ranging from 0.5×10\^6/kg to 5.0×10\^6/kg CAR+ cells.
CAR-T-19 Cells
T cells were isolated from the PBMC of patients, transduced with lentivirus, expanded in vitro, and infused into patients. The escalated doses include 0.5×10\^6/kg,1.5×10\^6/kg, 5.0×10\^6/kg CAR+ cells.
Interventions
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CAR-T-19 Cells
T cells were isolated from the PBMC of patients, transduced with lentivirus, expanded in vitro, and infused into patients. The escalated doses include 0.5×10\^6/kg,1.5×10\^6/kg, 5.0×10\^6/kg CAR+ cells.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
25 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Daihong Liu
Director
Principal Investigators
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Daihong Liu
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CT19-ALL-02
Identifier Type: -
Identifier Source: org_study_id
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