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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

Recruiting now EARLY_PHASE1 Last updated 7 January 2025
What this trial tests

EARLY_PHASE1 trial testing Human Derived anti-CI135 CAR-T Injection in Acute Myeloid Leukemia (AML) in 7 participants. Currently enrolling.

Timeline
26 January 2022
Primary endpoint
31 December 2025
31 December 2026

Quick facts

Lead sponsorHrain Biotechnology Co., Ltd.
PhaseEARLY_PHASE1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment7
Start date26 January 2022
Primary completion31 December 2025
Estimated completion31 December 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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:

Other recruiting trials for Acute Myeloid Leukemia (AML)

Currently open trials in the same condition.

Other Hrain Biotechnology Co., Ltd. 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/NCT06760260.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing