CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies
NCT ID: NCT04603872
Last Updated: 2020-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
120 participants
INTERVENTIONAL
2020-11-01
2026-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Administration of CD19/BCMA Targeted CAR T-cells and dasatinib
Dose levels of CAR-T cells are based on clinical trials of similar foreign products. Meanwhile, dasatinib would be combined as the following regimens: 1) Dasatinib preconditioning CAR-T cells during the manufacturing; 2) Dasatinib for the intervention of cytokine release storm after CAR-T cell infusion; 3) Dasatinib for the intervention of neurotoxicities after CAR-T cell infusion; 4) Dasatinib for the phase of CAR-T cell decreasing.
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.
Administration of CD19/BCMA Targeted CAR T-cells
Dose levels of CAR-T cells are based on clinical trials of similar foreign products.
CD19/BCMA Targeted CAR T-cells
Each subject receive CS1 Targeted CAR T-cells by intravenous infusion.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Yake Biotechnology Ltd.
INDUSTRY
Zhejiang University
OTHER
Responsible Party
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He Huang
Clinical Professor
Locations
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The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DASA001
Identifier Type: -
Identifier Source: org_study_id