NCT04340154

Study of Sequential CAR-T Cell Treating Leukemia Children

Terminated Phase 2 Last updated 5 December 2024

What this trial tests

Phase 2 trial testing chimeric antigen receptor T cell in Acute Lymphoblastic Leukemia in 81 participants. Terminated before completion.

Timeline

1 May 2020

Primary endpoint
1 May 2024

30 November 2024

Quick facts

Lead sponsor	Beijing Boren Hospital
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	81
Start date	1 May 2020
Primary completion	1 May 2024
Estimated completion	30 November 2024
Sites	1 location across China

Drugs / interventions tested

• chimeric antigen receptor T cell — full drug profile →

Conditions studied

• Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
• Acute Lymphoblastic Leukemia, in Relapse — all drugs for Acute Lymphoblastic Leukemia, in Relapse →
• Refractory Acute Lymphoid Leukemia — all drugs for Refractory Acute Lymphoid Leukemia →

Sponsor

Beijing Boren Hospital

Who can join

Adults 0 to 18, any sex, with Acute Lymphoblastic Leukemia or Acute Lymphoblastic Leukemia, in Relapse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Enhancing the safety of CAR-T cell therapy: Synthetic genetic switch for spatiotemporal control.
   Lu L, Xie M, Yang B, Zhao WB, et al · · 2024 · cited 52× · PMID 38394207 · DOI 10.1126/sciadv.adj6251
2. Sequential CD19 and CD22 chimeric antigen receptor T-cell therapy for childhood refractory or relapsed B-cell acute lymphocytic leukaemia: a single-arm, phase 2 study.
   Pan J, Tang K, Luo Y, Seery S, et al · · 2023 · cited 46× · PMID 37863088 · DOI 10.1016/s1470-2045(23)00436-9
3. Targeting CD22 for the Treatment of B-Cell Malignancies.
   Shah NN, Sokol L. · · 2021 · cited 42× · PMID 34262884 · DOI 10.2147/itt.s288546
4. Targeting macrophages in cancer immunotherapy: Frontiers and challenges.
   Liu Y, Tan H, Dai J, Lin J, et al · · 2025 · cited 24× · PMID 39778768 · DOI 10.1016/j.jare.2024.12.043
5. Challenges and strategies associated with CAR-T cell therapy in blood malignancies.
   Liu Z, Lei W, Wang H, Liu X, et al · · 2024 · cited 23× · PMID 38402232 · DOI 10.1186/s40164-024-00490-x
6. Strategies to Overcome Antigen Heterogeneity in CAR-T Cell Therapy.
   Zhang B, Wu J, Jiang H, Zhou M. · · 2025 · cited 9× · PMID 40072049 · DOI 10.3390/cells14050320
7. Revolutionizing Cancer Treatments through Stem Cell-Derived CAR T Cells for Immunotherapy: Opening New Horizons for the Future of Oncology.
   Mishra HK, Kalyuzhny A. · · 2024 · cited 6× · PMID 39329700 · DOI 10.3390/cells13181516
8. Single-Cell Dissection Reveals Immune Dysregulation After CD5 or CD7-Directed Chimeric Antigen Receptor T-Cell Therapy.
   Luo Y, Zhang H, Tang K, Wang Y, et al · · 2026 · cited 1× · PMID 41290542 · DOI 10.1002/advs.202509259