CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL
Recruiting now · Early Phase 1
Conditions studied: Acute Lymphoblastic Leukemia,B-Cell, Non-hodgkin Lymphoma,B Cell
In brief
Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.
Key facts
- Study ID
- NCT06346912
- Run by
- Zhejiang University
- People needed
- 20
- Starts
- 2024-05-30
- Expected to finish
- 2027-05-30
- Last updated by the study team
- 2024-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 1. Gender unlimited，18< Age;
- 2. Patients diagnosed with B-cell acute lymphoblastic leukemia through histological or immunophenotyping tests; The clear diagnosis of B-cell non Hodgkin's lymphoma by cellular or histopathological examination mainly includes diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma
- 3. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
- CR not achieved after standardized chemotherapy;
- CR achieved following the first induction, but CR duration is less than 12 months;
- Ineffectively after first or multiple remedial treatments;
- 2 or more relapses;
- 4. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is >5% (by morphology), and/or >1% (by flow cytometry);
- 5. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
- 6. Relapsed or refractory B-NHL (meeting one of the following conditions):
- No response or relapse after second-line or above chemotherapy regimens;
- Primary drug resistance;
- Relapse after auto-HSCT;
- 7. At least one assessable tumor lesion per Lugano 2014 criteria;
- 8. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
- 9. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
- 10. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
- 11. Estimated survival time ≥ 3 months;
- 12. ECOG performance status 0 to 2;
- 13. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
You may not qualify if…
- 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
- 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- 3. Pregnant/lactating women, or male or female patients with fertility who are unwilling to take effective contraceptive measures during the study period or at least 6 months after the last cell infusion
- 4. Patients with HIV infection;
- 5. Active infection of hepatitis B virus or hepatitis C virus;
- 6. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- 7. Other uncontrolled diseases that were not suitable for this trial;
- 8. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 6 months;
- 9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Where it is running
- The first affiliated hospital of medical college of zhejiang university — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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