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NCT07008885

BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B-ALL

Recruiting now Phase 1, PHASE2 Last updated 25 June 2025
What this trial tests

Phase 1, PHASE2 trial testing CAR19TIF cells in Acute Lymphocytic Leukemia in 30 participants. Currently enrolling.

Timeline
20 June 2025
Primary endpoint
31 May 2026
31 May 2027

Quick facts

Lead sponsorChinese PLA General Hospital
PhasePhase 1, PHASE2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date20 June 2025
Primary completion31 May 2026
Estimated completion31 May 2027
Sites2 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Chinese PLA General Hospital

Who can join

Adults 18 to 70, any sex, with Acute Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this single-center, single-arm, prospective, Phase 1/2 study, the safety and efficacy of autologous BCOR and ZC3H12 genes knock-out CD19-targeting chimeric antigen receptor (CAR) T-cell therapy will be evaluated in patients with refractory/relapsed (r/r) B-cell acute lymphoblastic leukaemia (B-ALL). In phase 1, 3 eligible patients will be enrolled and receive BCOR and ZC3H12 genes knock-out CD19 CAR T cell therapy at a initial dose of 5×10\^5 cells/kg. Based on the results, . Subsequently an additional 3-15 patients will be enrolled in a "3+3" dose-escalation/decline design to adjust the dose of BCOR and ZC3H12 genes knock-out CD19 CAR T cells to achieve optimal safety and efficacy. The recommended Phase 2 dose (RP2D) will then be established. 10 to 12 subjects will be enrolled and receive BCOR and ZC3H12 genes knock-out CD19 CAR T cell infusion at dose of RP2D.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Mechanisms of Resistance to CAR T-Cells and How to Overcome Them.
    Legato L, Bisio M, Fasano F, Benevolo Savelli C, et al · · 2025 · cited 3× · PMID 40981226 · DOI 10.3390/mps8050108

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Other trials of CAR19TIF cells

Trials testing the same drug.

Other recruiting trials for Acute Lymphocytic Leukemia

Currently open trials in the same condition.

Other Chinese PLA General Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07008885.

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