NCT04603872 CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies
| NCT ID | NCT04603872 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Zhejiang University |
| Condition | Multiple Myeloma in Relapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2020-11-01 |
| Primary Completion | 2023-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2020-11-01 with a primary completion date of 2023-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04603872 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Multiple Myeloma in Relapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04603872 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04603872 currently recruiting?
Yes, NCT04603872 is actively recruiting participants. Contact the research team at hehuangyu@126.com for enrollment information.
Where is the NCT04603872 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT04603872 clinical trial?
NCT04603872 is sponsored by Zhejiang University. The trial plans to enroll 120 participants.