Acute Myeloid Leukemia
Conditions
Keywords
CD38, CART, AML
Brief summary
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.
Detailed description
The patients will receive infusion of CAR T-cells targeting CD38 to confirm the safety and efficacy of CD38 CAR T-Cells in relapsed or refractory acute myeloid leukemia.
Interventions
BIOLOGICALCART-38
Split intravenous infusion of CART-38 cells \[dose escalating infusion of (5-20)x10\^6 CART-38 cells/kg\].
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | 12 months | Adverse events are evaluated with CTCAE V5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of relapse(CIR) | 2 years | time from the date of achievement of a remission until the date of relapse. |
| Overall response rate (ORR) | 2 years | 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%. |
| Event-free survival (EFS) | 2 years | time from enrollment to the date of primary refractory disease, or relapse from CR or CRi, or death from any cause. |
Countries
China
Contacts
Primary ContactXiaowen Tang, Ph.D
Backup ContactLei Yu, Ph.D
Outcome results
None listed