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

Last updated: October 27, 2020
Sponsor: Zhejiang University
Overall Status: Active - Recruiting

Phase

1

Condition

Leukemia

Multiple Myeloma

Lymphoma

Treatment

N/A

Clinical Study ID

NCT04603872
DASA001
  • Ages 18-70
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the USNational Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2);
  2. Relapsed or refractory B cell hematological malignancies (meeting one of the followingconditions):
  3. CR not achieved after standardized chemotherapy;
  4. CR achieved following the first induction, but CR duration is less than 12months;
  5. Ineffectively after first or multiple remedial treatments;
  6. 2 or more relapses;
  7. Relapse after hematopoietic stem cell transplantation;
  8. Extramedullary leisions which were ineffective to radiotherapy or chemotherapy;
  9. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
  10. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
  11. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
  12. Estimated survival time ≥ 12 weeks;
  13. ECOG performance status 0 to 2;
  14. Women of childbearing age had negative pregnancy test during screening period andbefore administration, and agreed to take effective contraceptive measures at leastone year after infusion.
  15. Patients volunteer to participate in the study and sign the informed consent.

Exclusion

Exclusion Criteria: Subjects with any of the following exclusion criteria were not eligible for this trial:

  1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascularischemia, and cerebrovascular, hemorrhagic diseases;
  2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severearrhythmia in the past;
  3. Pregnant (or lactating) women;
  4. Patients with severe active infections (excluding simple urinary tract infection andbacterial pharyngitis);
  5. Active infection of hepatitis B virus or hepatitis C virus;
  6. Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except forthe patients recently or currently receiving in haledsteroids;
  7. Previously treated with any CAR-T cell product or other genetically-modified T celltherapies;
  8. Creatinine >2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin >2.0mg/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 orinterfere with the results of study.

Study Design

Total Participants: 120
Study Start date:
November 01, 2020
Estimated Completion Date:
November 01, 2026

Study Description

This is a double-arm, single-center study. This study is indicated for relapsed and/or refractory B-cell acute lymphoblastic leukemia, B-cell non-Hodgkin's lymphoma and multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 120 patients will be enrolled for this trial. Primary objective is to explore the safety.

Connect with a study center

  • The First Hospital of Zhejiang Medical Colleage Zhejiang University

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

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