Clinical trial · Interventional
CD38-targeted Chimeric Antigen Receptor T Cell (CART) in Relapesd or Refractory Acute Myeloid Leukemia
Pilot Study of the Efficacy and Safety of CD38 Targeted Chimeric Antigen Receptor Engineered T-Cells in the Treatment of CD38 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
NCT04351022CI-TRIAL-00044808unknownPhase 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 targeted CD38 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD38 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 |
|---|---|---|---|
| CART-38 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD38 positive relapsed or refractory acute myeloid leukemia
- interventionNames
- Biological: CART-38
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 (\<1.0x10\^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: * CD38 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 (2)
- DERIVEDCui Q, Liang P, Dai H, Cui W, Cai M, Ding Z, Ma Q, Yin J, Li Z, Liu S, Kang L, Yao L, Cen J, Shen H, Zhu M, Yu L, Wu D, Tang X. Case report: CD38-directed CAR-T cell therapy: A novel immunotherapy targeting CD38- positive blasts overcomes TKI and chemotherapy resistance of myeloid chronic myeloid leukemia in blastic phase. Front Immunol. 2022 Nov 29;13:1012981. doi: 10.3389/fimmu.2022.1012981. eCollection 2022. PMID 36524116
- DERIVEDCui Q, Qian C, Xu N, Kang L, Dai H, Cui W, Song B, Yin J, Li Z, Zhu X, Qu C, Liu T, Shen W, Zhu M, Yu L, Wu D, Tang X. CD38-directed CAR-T cell therapy: a novel immunotherapy strategy for relapsed acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation. J Hematol Oncol. 2021 May 25;14(1):82. doi: 10.1186/s13045-021-01092-4. PMID 34034795