Clinical trial · Interventional
Donor-derived CAR-T Cells in the Treatment of AML Patients
A Study to Evaluate the Safety and Efficacy of Donor-derived CAR-T Cells in the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT04766840CI-TRIAL-00050252unknownPhase 1ClinicalTrials.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 clinical study to evaluate the safety and efficacy of donor-derived CAR-T cells in the treatment of patients with relapsed or refractory acute myeloid leukemia in China.
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 |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IM73 CAR-T
- description
- Drug: IM73 CAR-T Cells * Fludarabine * Cyclophosphamide
- interventionNames
- Drug: CAR-T cells
Primary outcomes (1)
- measure
- Dose limiting toxicity
- timeFrame
- 28 days
- description
- ≥ Grade 4 adverse event related to CAR-T cells infusion
Secondary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 28 days
- description
- Patients who achieve CR（complete response） or CRi 28 days after CAR-T cells infusuion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Refractory or relapsed AML patients. * Have found an appropriate matched donor for CAR-T cells manufacturing. * Patients must have evaluable evidence of disease. * Age ≥ 18 years; Expected survival is more than 3 months. * ECOG score 0-2 points. * Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up. * Adequet liver, kidney, heart and lung function. Exclusion Criteria: * Confirmed acute promyelocytic leukemia; or recent symptomatic central nervous system leukemia. * Patients with graft-versus-host disease requiring the use of immunosuppressive agents; or patients with autoimmune system diseases. * Prior use of any gene therapy product. * History of epilepsy or other central nervous system diseases. * Presence of concurrent active malignancy. * Active hepatitis B or C virus, patients with HIV or syphilis infection. * Currently participating in or having participated in other drug clinical trials during past 30 days. * Active or uncontrolled infection requiring systemic therapy within 14 days prior to enrollment. * Other situations not suitable for the study judged by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.