CD38-targeted Chimeric Antigen Receptor T Cell (CART) in Relapesd or Refractory Acute Myeloid Leukemia

Phase 1

• Conditions: Acute Myeloid Leukemia
• Interventions: Biological: CART-38

• Registration Number: NCT04351022
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-17
• Last Update Submitted: 2020-04-21
• Last Update Posted: 2020-04-24
• Primary Completion: 2021-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD38 positive relapsed or refractory acute myeloid leukemia	CART-38	-

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	12 months	Adverse events are evaluated with CTCAE V5.0

Secondary Outcome Measures

Name	Time	Method
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.
Cumulative incidence of relapse(CIR)	2 years	time from the date of achievement of a remission until the date of relapse.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China