NCT04340154

Study of Sequential CAR-T Cell Treating Leukemia Children

Phase II Study of Sequential Chimeric Antigen Receptor T Cell Targeting at Different B-cell Antigens Treating Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Children

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Beijing Boren Hospital · Academic / Other
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators will conduct a phase II clinical trial of sequential chimeric antigen receptor T cell targeting at different B-cell antigens in refractory or relapsed B-cell acute lymphoblastic leukemia children in Beijing Boren Hospital. The study will be approved by the institutional review board of Beijing Boren Hospital, and informed consent will be obtained in accordance with the Declaration of Helsinki. All these participants will be matched the diagnostic criteria for (r/r) B-ALL according to the WHO classification and complete morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis and leukemia fusion gene screening by multiplex nested reverse transcriptase-polymerase chain reaction (PCR). Participants will be eligible if they are heavily treated B-ALL who failed from re-induction chemotherapy after relapse or continued MRD+ for more than three months, and had positive CD19 and CD22 expressions on leukemia blasts by FCM (\>95% CD19 and \>95% CD22). After CAR T-cell infusion, clinical outcomes including overall survival (OS), disease-free survival (DFS), adverse effects and relapse will be evaluated.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Lymphoblastic Leukemia, in Relapse
• Refractory Acute Lymphoid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	chimeric antigen receptor T cell	CAR-T cells were manufactured from peripheral blood mononuclear cells collected by leukapheresis and frozen for multiple uses. Before each CAR T-cell infusion (day 0), patients received lymphodepleting chemotherapy composing of Fludarabine (30 mg/m2/day) and Cyclophosphamide (250 mg/m2/day) on days -5 to -3. No bridging chemotherapy was given between enrollment and infusion. In sequential CAR-T clinical trials, CAR-T cells will be given twice（anti-CD19 CAR-T first, then anti-CD22 CAR-T). All patients underwent bone marrow (BM) biopsy examination and radiology studies on days 30 and every month to determine the response and remission status. Bone biopsy, MRD status by FCM and RT-PCR (if the patient had fusion gene), and EMDs evaluation by CT/MRI/PET-CT were also conducted before CAR-T cell infusion to determine the disease status.

Timeline

• Start date: 2020-05-01
• Primary completion: 2024-05-01
• Completion: 2024-11-30
• First posted: 2020-04-09
• Last updated: 2024-12-05

Locations

1 site across 1 country: China