Actively Recruiting
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
Led by Zhejiang University · Updated on 2020-10-28
120
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and effects of CD19/BCMA-targeted CAR-T cells combined with dasatinib in patients who have relapsed or refractory B-cell acute lymphoblastic leukemia, B-cell non-Hodgkin's lymphoma, or multiple myeloma. This early phase 1 trial aims primarily to explore the safety of this combination treatment, enrolling 120 patients based on similar clinical trials from other countries. Participants will be randomly assigned to one of two groups: one receiving CD19/BCMA-targeted CAR-T cells combined with dasatinib, and the other receiving the CAR-T cells alone. The dasatinib is given in several ways including preconditioning during CAR-T cell manufacturing, and as intervention to manage side effects like cytokine release syndrome, neurotoxicities, and during the phase when CAR-T cells decrease. CAR-T cells are administered by intravenous infusion. Throughout the study, participants will be closely monitored for side effects and treatment responses. This includes tracking dose-limiting toxicity and treatment-emergent adverse events up to two years after infusion. Researchers will also evaluate overall response rates, survival outcomes, quality of life, and mental health at multiple time points up to two years. The total participation duration includes ongoing safety and effectiveness assessments over this period.
CONDITIONS
Brief Title
CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of CD19+ acute lymphoblastic leukemia, CD19+ non-Hodgkin's lymphoma, or BCMA+ multiple myeloma according to NCCN guidelines
- Relapsed or refractory B cell hematological malignancies meeting one of these: no complete remission after standard chemotherapy, remission lasting less than 12 months after first induction, ineffective after remedial treatments, two or more relapses, relapse after stem cell transplant, or extramedullary lesions unresponsive to radiotherapy or chemotherapy
- Total bilirubin ≤ 51 umol/L; ALT and AST ≤ 3 times upper limit of normal; creatinine ≤ 176.8 umol/L
- Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram
- No active lung infection and blood oxygen saturation ≥ 92% in room air
- Estimated survival of at least 12 weeks
- ECOG performance status between 0 and 2
- Negative pregnancy test for women of childbearing age and agreement to use effective contraception for at least one year after infusion
- Willingness to participate and signed informed consent
You will not qualify if you...
- History of brain injury, unconsciousness, epilepsy, cerebrovascular ischemia, or hemorrhagic diseases
- Electrocardiogram showing prolonged QT interval or history of severe heart diseases such as serious arrhythmia
- Pregnant or breastfeeding women
- Severe active infections except simple urinary tract infection or bacterial pharyngitis
- Active hepatitis B or C infection
- Use of systemic steroids within 2 weeks before screening (except inhaled steroids)
- Prior treatment with any CAR-T or genetically-modified T cell therapy
- Creatinine > 2.5 mg/dl, ALT/AST > 3 times normal, or bilirubin > 2.0 mg/dl
- Other uncontrolled diseases unsuitable for trial participation
- HIV infection
- Any condition that may increase risk or interfere with the study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days after CAR T-cells infusion
Participants receive CD19/BCMA targeted CAR T-cells by intravenous infusion, with some also receiving dasatinib combined according to specific regimens including preconditioning, intervention for cytokine release syndrome, neurotoxicities, and during CAR-T cell decrease phase.
1 baseline visit and multiple visits during first 28 days after infusion
Duration - Up to 2 years after CAR T-cells infusion
Participants are monitored for treatment-emergent adverse events, overall response rate, survival outcomes, quality of life, and functional scores for up to 2 years after CAR T-cells infusion.
Visits at Month 1, 3, 6, 9, 12, 18, and 24 depending on measures
Trial Site Locations
Total: 1 location
1
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Huang, PhD
Y
Yongxian Hu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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