CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies
Clinical Trial for the Safety and Efficacy of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma
Zhejiang University
120 participants
Nov 1, 2020
INTERVENTIONAL
Conditions
Summary
A Study of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma.
Eligibility
Inclusion Criteria15
- Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2);
- Relapsed or refractory B cell hematological malignancies (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;
- or more relapses;
- Relapse after hematopoietic stem cell transplantation;
- Extramedullary leisions which were ineffective to radiotherapy or chemotherapy;
- Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
- Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
- No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
- Estimated survival time ≥ 12 weeks;
- ECOG performance status 0 to 2;
- Women of childbearing age had negative pregnancy test during screening period and before administration, and agreed to take effective contraceptive measures at least one year after infusion.
- Patients volunteer to participate in the study and sign the informed consent.
Exclusion Criteria11
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
- Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
- Creatinine \>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin \>2.0 mg/dl;
- Other uncontrolled diseases that were not suitable for this trial;
- Patients with HIV infection;
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Interventions
Each subject receive CS1 Targeted CAR T-cells by intravenous infusion, and the dasatinib was combined according to the presumed regimens.
Each subject receive CS1 Targeted CAR T-cells by intravenous infusion.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04603872