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

Who is this study for? Patients with Multiple Myeloma
What treatments are being studied? CD19/BCMA Targeted CAR T-cells
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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;

⁃ 2 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.

Locations
Other Locations
China
The First Hospital of Zhejiang Medical Colleage Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
He Huang, PhD
hehuangyu@126.com
86-13605714822
Backup
Yongxian Hu, PhD
huyongxian2000@aliyun.com
86-15957162012
Time Frame
Start Date: 2020-11-01
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 120
Treatments
Experimental: 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.
Experimental: Administration of CD19/BCMA Targeted CAR T-cells
Dose levels of CAR-T cells are based on clinical trials of similar foreign products.
Sponsors
Collaborators: Yake Biotechnology Ltd.
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov

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