Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
Conditions
Brief summary
The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.
Interventions
BIOLOGICALB019
B019： Intravenous infusion, 1.0×10\^6 CAR T cell/kg-10.0×10\^6 CAR T cell/kg
Sponsors
Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1. The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form； 2. Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia； 3. Documentation of CD19/CD22 tumor expression 3\. Liver, kidney, lung and heart function meet requirements; 4. Expected survival \>3 months; 5. Women of childbearing age and all post-adolescent male participants are willing to use highly effective contraceptive methods within 1 year after the infusion of B019 injection. At the same time, the subject should promise not to donate eggs or sperm for assisted reproduction for 1 year after the cell infusion. \-
Exclusion criteria
1. Active CNS involvement by malignancy； 2. Isolated extramedullary leukemia recurrence； 3. Subjects with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening; 4. Has had treatment with any prior CAR-T therapy or other therapy abandoned in protocal. 4\. Subjects who received therapy abandoned in protocal before PBMC (peripheral blood mononuclear cells) collection or before B019 injection; 5.Active other malignancy in 5 years. 6. Subjects who are positive for any of HBsAg, HBeAg, HBeAb, HBcAb, HCV-RNA, HIV EBV DNA, CMV DNA, HTLV-ab. 7\. Other situations deemed inappropriate for participation in this study by the investigator. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Approximately 2 years | Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The overall response rate (ORR) | 3 months | Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1. |
| Overall Survival (OS) | Approximately 2 years | Determination of the overall survival times of all patients. |
| PK(Pharmacokinetics):Tmax | Approximately 2 years | Time to peak plasma concentration (Tmax) |
| PK(Pharmacokinetics):Cmax | Approximately 2 years | Maximum serum concentration(Cmax) |
Countries
China
Contacts
CONTACTJing Chen
Outcome results
None listed