This is a phase II clinical study to evaluate the safety and efficacy of CAR-T-19 injection in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.
Voluntary participation in clinical trial, The Participants or his legal guardian is fully understands this clinical trial and signs the Informed Consent Form (ICF); Willing to follow and be able to complete all trial procedures.
Age≤25 years old at the time of screening, regardless of gender.
Bone marrow examination confirmed the diagnosis of B-ALL, and meet one of the following conditions： Relapsed B-ALL：1）Relapse within 12 months of the first remission；2）Recurrence occurring again more than 12 months after the first remission,, relapsed or not responded after first-line/multi-line salvage chemotherapy；3) Experienced two or more bone marrow recurrences; 4） recurrence after autologous or allogeneic hematopoietic stem cell transplantation； Refractory B-ALL：1）failed to achieve complete remission after 2 cycles of standard induction chemotherapy.
Ph+ALL patients are eligible：1）Relapsed or refractory after receiving at least two Tyrosine kinase inhibitors (TKI) treatments；If Ph+ALL patients with t315i mutation are resistant to first- and second-generation TKIs, in the absence of effective TKI therapy, patients are not required to receive at least two TKIs；2）cannot tolerate TKI treatment；3）Presence of contraindications to TKI therapy.
Isolated extra-medullary disease relapse .
Participants with genetic syndromes, Patients with Down Syndrome will not be excluded.
Participants with Burkitt's lymphoma/leukemia.
Participants with active central nervous system disease.
Single group
CAR-T-19 cell injection
Biological/VaccineThe functional component of CAR-T-19 cell injection is T cells that have been genetically modified to express anti CD19 chimeric antigen receptors.
Objective response rate(ORR)
ORR included complete response (CR) and CR with incomplete blood count recovery (CRi) as determined by an Independent Review Committee（IRC） assessment.
ORR
ORR at 3 months after CAR-T-19 infusion as assessed by investigator.
ORR
ORR at 28 days after CAR-T-19 infusion as assessed by IRC and investigator.
Minimal residual disease（MRD）
MRD-negative ORR as assessed by Independent Review Committee (IRC) and investigator.
Best overall response (BOR)
BOR as assessed by Independent Review Committee (IRC) and investigator.
Click on the lead sponsor to view all of their trials.
