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

Launched by ZHEJIANG UNIVERSITY · Oct 21, 2020

Keywords

ClinConnect Summary

This clinical trial is examining a new treatment option for patients with certain types of blood cancers, specifically those who have had their cancer come back or haven’t responded to previous treatments. The study is testing a combination of CAR-T cells, a type of immune therapy that helps the body fight cancer, and a medication called dasatinib. The focus is on patients with B-cell acute lymphoblastic leukemia, B-cell non-Hodgkin's lymphoma, and multiple myeloma who have not had success with standard treatments.

To be eligible for this trial, participants need to have specific types of these blood cancers that are confirmed by a doctor, and they should have experienced multiple relapses or have not responded to treatment. Other important factors include having stable organ function and being able to participate for at least 12 weeks. Participants will receive the new treatment and be closely monitored for its effects and any side effects. This trial is currently recruiting patients of all genders, aged 65 to 75, and is designed to find out if this combination therapy can improve outcomes for those with challenging blood cancers.

Gender

ALL

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.