CAR-T cell therapy combined with dasatinib for relapsed B-cell cancers

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

This study is testing a new treatment that combines CAR-T cell therapy with dasatinib to see if it helps people with relapsed B-cell cancers feel better.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Zhejiang University (other)
• Drugs / interventions: CAR-T, chemotherapy, Dasatinib
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT04603872 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of CD19/BCMA-targeted CAR-T cells in combination with dasatinib for patients suffering from relapsed or refractory B-cell hematological malignancies, including acute lymphoblastic leukemia, non-Hodgkin's lymphoma, and multiple myeloma. The study is designed as a double-arm, single-center trial enrolling 120 patients, focusing primarily on assessing the safety of the treatment. The selection of dose levels and patient numbers is informed by previous clinical trials of similar therapies.

Who should consider this trial

Good fit: Ideal candidates include individuals with relapsed or refractory B-cell acute lymphoblastic leukemia, B-cell non-Hodgkin's lymphoma, or multiple myeloma who have not responded to standard treatments.

Not a fit: Patients with active infections, significant organ dysfunction, or those who do not meet the specific hematological criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.

How similar studies have performed: Other studies have shown promising results with CAR-T cell therapies for similar conditions, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2);
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:

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

1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
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.

Where this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Study coordinator: He Huang, PhD

Conditions: 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, Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma