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Clinical Trials in China / NCT04603872
Recruiting Phase EARLY_PHASE1

CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies

NCT04603872 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang University
Phase
Phase EARLY_PHASE1
Started
2020-11-01
Last updated
2020-10-28

Condition(s) studied

Multiple Myeloma in RelapseMultiple Myeloma, RefractoryAcute Lymphoblastic Leukemia, in RelapseAcute Lymphocytic Leukaemia RefractoryNon-Hodgkin's Lymphoma, RelapsedNon-Hodgkin's Lymphoma Refractory

Investigational drug(s) / intervention(s)

CD19/BCMA Targeted CAR T-cells and dasatinibCD19/BCMA Targeted CAR T-cells

CD19/BCMA Targeted CAR T-cells and dasatinib: Each subject receive CS1 Targeted CAR T-cells by intravenous infusion, and the dasatinib was combined according to the presumed regimens.

CD19/BCMA Targeted CAR T-cells: Each subject receive CS1 Targeted CAR T-cells by intravenous infusion.

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2); 2. Relapsed or refractory B cell hematological malignancies (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; 5. Relapse after hematopoietic stem cell transplantation; 6. Extramedullary leisions which were ineffective to radiotherapy or chemotherapy; 3. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L; 4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; 5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%; 6. Estimated survival time ≥ 12 weeks; 7. ECOG performance status 0 to 2; 8. 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. 9. Patients volunteer to participate in the study and sign the informed consent. Exclusion Criteria: Subjects with any of the following exclusion criteria were not eligible for this trial: 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 (or lactating) women; 4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 5. Active infection of hepatitis B virus or hepatitis C virus; 6. Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids; 7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; 8. Creatinine \>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin \>2.0 mg/dl; 9. Other uncontrolled diseases that were not suitable for this trial; 10. Patients with HIV infection; 11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Hospital of Zhejiang Medical Colleage Zhejiang University Hangzhou Zhejiang Recruiting

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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 NCT04603872 on ClinicalTrials.gov ↗ ← All trials in China