Clinical trial · Interventional
Clinical Study on Safety and Efficacy of Anti-CLL1 /+CD33 CAR T Cells in the Treatment of Acute Myeloid Leukemia
Safety and Efficacy of Anti-CLL1 /+CD33 CAR T Cells in Refractory/Recurrent Acute Myeloid Leukemia: a Single-arm, Non-blind Clinical Study
NCT05943314CI-TRIAL-00071025withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The clinical trial was terminated due to a change in sponsor strategy.
Summary
Brief summary (as posted)
This is a single-center, single-arm, open, intravenous drug administration of the safety and efficacy of clinical study.
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 |
|---|---|---|---|
| CLL1/+CD33 CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CLL1/+CD33 CAR-T
- description
- The target dose range for subjects was set to be 1.00\~2.50x10\^6/kg CAR-positive T cells.
- interventionNames
- Biological: CLL1/+CD33 CAR-T
Primary outcomes (3)
- measure
- Changes in cytokine level after CLL1/+CD33 CAR-T infusion
- timeFrame
- CAR T cell infusion before and 12 months after infusion
- description
- Calculate the change of cytokine level in peripheral blood by flow cytometry after CAR-T infusion.
- measure
- The change characteristics of chimeric antigen receptor(CAR)-T cell number in patients after infusion.
- timeFrame
- CAR T cell infusion before and 12 months after infusion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient or his/her legal guardian volunteers for the trial and signs an informed consent form; 2. Age range 1-18 years; 3. Acute myeloid leukemia (AML) with CLL1 and CD33 markers (including secondary patients) was diagnosed by pathology, histology and flow cytometry, or complete hematologic remission could not be achieved after 1 course of chemotherapy for hematologic relapse after drug withdrawal ; 4. The main organ functions of the patients were good: (1) liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and bilirubin ≤34.2 μmol/l; (2) renal function: creatinine \< 220 μmol/l; (3) lung function: oxygen saturation ≥95% ; (4) cardiac function: left ventricular ejection fraction (LVEF)≥40% ; 5. The blood flow of peripheral superficial vein was unobstructed, which could meet the demands of intravenous drip and mononuclear cell collection; 6. ECOG score was 0-2. Exclusion Criteria: 1. The patients had uncontrollable infectious diseases within 4 weeks before the enrollment; 2. Active hepatitis B/C virus; 3. HIV infection, treponema syphilis positive patients; 4. Pathological diagnosis of primary tumors other than acute myeloid leukemia; 5. Suffering from serious autoimmune diseases or immunodeficiency diseases; 6. The patient is allergic to antibodies or cytokines and other macromolecular biological drugs; 7. Pregnant or lactating women; 8. Patients who were considered ineligible for study for other reasons.
References
Publications (0)
Data not yet available
No reference posted for this study.