A Phase 2 interventional study of chimeric antigen receptor T cell in Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, in Relapse and Refractory Acute Lymphoid Leukemia, sponsored by Beijing Boren Hospital. Terminated at 1 site in China. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Beijing Boren Hospital · Phase 2, Interventional, and Treatment
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.
2,121 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 492 are open to participants now.
This study's enrollment of 81 is above the median of 40 across 1,691 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Beijing Boren Hospital is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Objective response rate (ORR)
according to NCCN, Complete response (CR), CR with incomplete blood count recovery(CRi) .
Time frame: during three months (±1 week) post CD19 CAR T-cell infusion
Plan to share: No
This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Precursor Cell Lymphoblastic Leukemia-Lymphoma →
Beijing Boren Hospital