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Recruiting Early Phase 1

CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL

NCT06346912 · tracked via the Priya Life Science China tracker
Phase
Early Phase 1
Started
2024-05-30
Last updated
2024-05-14

Condition(s) studied

Acute Lymphoblastic Leukemia,B-CellNon-hodgkin Lymphoma,B Cell

Investigational drug(s) / intervention(s)

CD19-BAFF Targeted CAR T-cells

CD19-BAFF Targeted CAR T-cells: Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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): 1. CR not achieved after standardized chemotherapy; 2. CR achieved following the first induction, but CR duration is less than 12 months; 3. Ineffectively after first or multiple remedial treatments; 4. 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): 1. No response or relapse after second-line or above chemotherapy regimens; 2. Primary drug resistance; 3. 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 Criteria: * 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.

Primary outcome measure(s)

  • Dose-limiting toxicity (DLT) — Up to 28 years after Treatment
    Adverse events assessed according to NCI-CTCAE v5.0 criteria
  • Incidence of treatment-emergent adverse events (TEAEs) — Up to 2 years after Treatment
    Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Trial sites (1)

FacilityCityRegionStatus
The first affiliated hospital of medical college of zhejiang university Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06346912 on ClinicalTrials.gov ↗ ← All trials in China