Last updated: October 27, 2020
Sponsor: Zhejiang University
Overall Status: Active - Recruiting
Phase
1
Condition
Leukemia
Multiple Myeloma
Lymphoma
Treatment
N/AClinical Study ID
NCT04603872
DASA001
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the USNational Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2);
- Relapsed or refractory B cell hematological malignancies (meeting one of the followingconditions):
- CR not achieved after standardized chemotherapy;
- CR achieved following the first induction, but CR duration is less than 12months;
- 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 andbefore administration, and agreed to take effective contraceptive measures at leastone year after infusion.
- 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:
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascularischemia, and cerebrovascular, hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severearrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infection andbacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except forthe patients recently or currently receiving in haledsteroids;
- Previously treated with any CAR-T cell product or other genetically-modified T celltherapies;
- Creatinine >2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin >2.0mg/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 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
Connect with a study center
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.