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

Recruiting now · Early Phase 1

Conditions studied: Multiple Myeloma in Relapse, Multiple Myeloma, Refractory, Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphocytic Leukaemia Refractory, Non-Hodgkin's Lymphoma, Relapsed, Non-Hodgkin's Lymphoma Refractory

In brief

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.

Key facts

Study ID

NCT04603872

Run by

Zhejiang University

People needed

120

Starts

2020-11-01

Expected to finish

2026-11-01

Last updated by the study team

2020-10-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subjects with any of the following exclusion criteria were not eligible for this trial:
• History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
• Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• Pregnant (or lactating) women;
• Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
• Active infection of hepatitis B virus or hepatitis C virus;
• Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
• Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
• Creatinine >2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin >2.0 mg/dl;
• Other uncontrolled diseases that were not suitable for this trial;
• Patients with HIV infection;
• Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Where it is running

• The First Hospital of Zhejiang Medical Colleage Zhejiang University — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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