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NCT06760260
Evaluation of the Safety and Efficacy of Human CI-135 (FLT3) Targeted CAR-T Cells Injection for Subjects with Relapsed/Refractory Acute Myeloid Leukemia
EARLY_PHASE1 trial testing Human Derived anti-CI135 CAR-T Injection in Acute Myeloid Leukemia (AML) in 7 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Hrain Biotechnology Co., Ltd. |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 26 January 2022 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Human Derived anti-CI135 CAR-T Injection — full drug profile →
Conditions studied
- Acute Myeloid Leukemia (AML) — all drugs for Acute Myeloid Leukemia (AML) →
Sponsor
Hrain Biotechnology Co., Ltd. — full company profile →
Who can join
Adults 18 to 70, any sex, with Acute Myeloid Leukemia (AML). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a single-arm, open-label, dose-escalating trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of anti human CI-135 (FLT3) CAR-T Injection , and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory Acute Myeloid Leukemia.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Next-generation CAR-T therapy for acute myeloid leukemia: bridging innovation with clinical translation.
Zhao X, Ming X, Wu J, Zhu X, et al · · 2026 · cited 1× · PMID 41537901 · DOI 10.1007/s00277-026-06742-6 -
Co-Expression of IL-2 Enhances the Efficacy of FLT3-CAR-γδT Cells in Acute Myeloid Leukemia.
Wang X, You F, Gu Y, Ma X, et al · · 2026 · PMID 41899506 · DOI 10.3390/cancers18060901 -
Resistance to Targeted Therapy in AML: Current Challenges and Emerging Treatment Strategies.
Stafylidis C, Diamantopoulos PT. · · 2026 · PMID 41899095 · DOI 10.3390/jcm15062171
Verify or expand the search:
- PubMed search for NCT06760260
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Myeloid Leukemia (AML)
Currently open trials in the same condition.
- NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
- NCT07500441 — Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML · recruiting
- NCT07410494 — Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06707493 — Ivosidenib as Post-HSCT Maintenance for AML · Phase 2 · recruiting
- NCT07458542 — Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia · active not recruiting
Other Hrain Biotechnology Co., Ltd. trials
Trials by the same sponsor.
- NCT06045091 — To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R/R MM or PCL · EARLY_PHASE1 · recruiting
- NCT05651191 — To Evaluate the Safety and Efficacy of Human CD19 Targeted DASH CAR-T Cells Injection for Subjects With R/R B-ALL · EARLY_PHASE1 · unknown
- NCT05651178 — Human CD19-CD22 Targeted T Cells Injection for Refractory/Relapsed Central Nervous System Leukemia/Lymphoma Patients · EARLY_PHASE1 · recruiting
- NCT05594797 — Human BCMA Targeted T Cells Injection(BCMA CAR-T)for Subjects With R/R MM · Phase 2 · recruiting
- NCT05223686 — To Evaluate the Safety and Tolerability of Human CD19-CD22 Targeted T Cells Injection for Subjects With R/R B-ALL. · Phase 1 · unknown
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 NCT06760260 (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 Hrain Biotechnology Co., Ltd.
- Last refreshed: 7 January 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/NCT06760260.
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