Clinical trial · Interventional
Anti-FLT3 CAR T-cell Therapy in FLT3 Positive Relapsed/Refractory Acute Myeloid Leukemia
Pilot Study of the Safety and Efficacy of Anti-FLT3 Chimeric Antigen Receptor Engineered T-Cells in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML)
NCT05023707CI-TRIAL-00055732unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective,open-label, phase1/2 study to evaluate the safety and efficacy of anti-FLT3 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of FLT3 positive relapsed or refractory acute myeloid leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-FLT3 CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T infusion
- description
- FLT3 positive relapsed or refractory acute myeloid leukemia
- interventionNames
- Biological: anti-FLT3 CAR-T
Primary outcomes (1)
- measure
- Number of Adverse Events
- timeFrame
- 12 months
- description
- Adverse events are evaluated with CTCAE V5.0
Secondary outcomes (3)
- measure
- Overall response rate (ORR)
- timeFrame
- 2 years
- description
- ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0x 10\^9/L; platelet count \>100x10\^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (\<1.0 x 109/L) or thrombocytopenia (\<100 x 109/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * FLT3 positive relapsed/refractory acute myeloid leukemia * Age 16-65 years. * Left ventricular ejection fractions ≥ 0.5 by echocardiography * Creatinine \< 1.5x upper limit of normal. * Aspartate aminotransferase/aspartate aminotransferase ≤ 2.5x upper limit of normal * Total bilirubin ≤ 1.5x upper limit of normal * Karnofsky performance status ≥ 60 * Expected survival time ≥ 3 months (according to investigator's judgement) Exclusion Criteria: * Patients are pregnant or lactating * Uncontrolled active infection * Grade III/IV cardiovascular disability according to the New York Heart * Association Classification * Active hepatitis B or hepatitis C infection * Patients with HIV infection * Patients with a history of seizure * Patients with other contraindications considered unsuitable for participation in this study (according to investigator's judgement)
References
Publications (0)
Data not yet available
No reference posted for this study.