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NCT07008885
BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B-ALL
Phase 1, PHASE2 trial testing CAR19TIF cells in Acute Lymphocytic Leukemia in 30 participants. Currently enrolling.
31 May 2026
Quick facts
| Lead sponsor | Chinese PLA General Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 20 June 2025 |
| Primary completion | 31 May 2026 |
| Estimated completion | 31 May 2027 |
| Sites | 2 locations across China |
Drugs / interventions tested
- CAR19TIF cells — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
Conditions studied
- Acute Lymphocytic Leukemia — all drugs for Acute Lymphocytic Leukemia →
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):
-
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
Verify or expand the search:
- PubMed search for NCT07008885
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CAR19TIF cells
Trials testing the same drug.
- NCT07009002 — BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B Cell Lymphoma · Phase 1, PHASE2 · recruiting
Other recruiting trials for Acute Lymphocytic Leukemia
Currently open trials in the same condition.
- NCT06904482 — Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood · Phase 2 · recruiting
- NCT06481735 — TCR Reserved and Power3 (SPPL3) Gene Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B-ALL · Phase 1, PHASE2 · recruiting
- NCT06476665 — A Study to Learn About the Safety of BESPONSA Injection in Pediatric Patients With Acute Lymphocytic Leukemia. · active not recruiting
- NCT06783816 — A Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors · NA · recruiting
- NCT06131801 — Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution · recruiting
Other Chinese PLA General Hospital trials
Trials by the same sponsor.
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- NCT07536607 — Predictive Role of Photon Counting Computed Tomography in Acute Coronary Syndrom Patients · not yet recruiting
- NCT07489157 — Real-Time End-Tidal Carbon Dioxide Monitoring for Early Warning of Hypoxemia in Painless Gastrointestinal Endoscopy · NA · not yet recruiting
- NCT07494981 — Individualized Precision Therapy With Ceftazidime and Avibactam Guided by PK/PD in Geriatric Populations · not yet recruiting
- NCT07496008 — Individualized Precision Isavuconazole Therapy Guided by PK/PD Principles for the Geriatric Population · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07008885 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese PLA General Hospital
- Last refreshed: 25 June 2025
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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