Clinical trial · Interventional
Anti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)
Pilot Study of the Safety and Efficacy of Anti-CLL1 Chimeric Antigen Receptor Engineered T-Cells in the Treatment of CLL1 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
NCT04884984CI-TRIAL-00051778unknownPhase 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 single center, open-label phase 1/2 study to evaluate the safety and efficacy of anti-CLL1 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CLL1 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-CLL1 CART | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CLL1 positive relapsed or refractory acute myeloid leukemia
- interventionNames
- Biological: anti-CLL1 CART
Primary outcomes (1)
- measure
- Number of Adverse Events
- timeFrame
- 12 months
- description
- Adverse events are evaluated with CTCAE V5.0
Secondary outcomes (4)
- 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 (\<1.0x10\^9/L) or thrombocytopenia (\<100x10\^9/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
- 6 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * CLL1 positive relapsed/refractory acute myeloid leukemia * Age 6-65 years * Left ventricular ejection fractions ≥ 0.5 by echocardiography * Creatinine \< 1.6 mg/dL * Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal * Total bilirubin \<2.0 mg/dL * Karnofsky performance status ≥ 60 * Expected survival time ≥ 3 months (according to investigator's judgement) Exclusion Criteria: * Patients are pregnant or lactating * Uncontrolled active infection * Class 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 history of seizure * Active central nervous system leukemia
References
Publications (0)
Data not yet available
No reference posted for this study.