A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.
Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.
Age
3–25
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
\-
You may not be if
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.
\-
Clareo Health | A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.
