Tests CD19-BAFF CAR-T cells in adults with returning B-cell leukemia or lymphoma
Tests CD19-BAFF CAR-T cells in adults with relapsed or refractory B-cell leukemia or lymphoma.
Plain-language title generated from the registry record
Registry title: CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Early phase 1
Where in China
- The first affiliated hospital of medical college of zhejiang universityHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhejiang University
- Trial code
- NCT06346912
- Record updated
- 14 May 2024
- Original description
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.Read full original descriptionShow less
A Study of CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL
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.
Inclusion: 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.
Exclusion: 8. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 6 months; 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; 4. Patients with HIV infection; 5. Active infection of hepatitis B virus or hepatitis C virus; 7. Other uncontrolled diseases that were not suitable for this trial; 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; 6. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; 9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.