Clinical trial NCT06927466: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
Lead sponsor: Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-15
Enrollment: 33
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.


Eligibility criteria: 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.

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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.

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Primary outcomes:
measure: (一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Approximately 2 years
Secondary outcomes:
measure: The overall response rate (ORR)
timeFrame: 3 months
measure: Overall Survival (OS)
timeFrame: Approximately 2 years
measure: PK(Pharmacokinetics):Tmax
timeFrame: Approximately 2 years
measure: PK(Pharmacokinetics):Cmax
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
city: Nanchang
country: China
facility: Jiangxi Province pediatric hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Shanghai
country: China
facility: Children's Hospital of Shanghai
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
city: Suzhou
country: China
facility: Children's Hospital of Soochow University
city: Wuhan
country: China
facility: Tongji Hospital
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
Study officials:
References: