CAR-T-19 Cells for Patients With CD19+ Relapse/Refractory B-ALL (NCT05270772) | Clinical Trial Compass
UnknownPhase 1
CAR-T-19 Cells for Patients With CD19+ Relapse/Refractory B-ALL
China9 participantsStarted 2021-02-25
Plain-language 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.
Who can participate
Age range25 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.