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

Primary Purpose

Acute Myeloid Leukemia

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CART-38

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring CD38, CART, AML

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD38 positive relapsed or refractory acute myeloid leukemia

Arm Description

Outcomes

Primary Outcome Measures

Number of Adverse Events

Adverse events are evaluated with CTCAE V5.0

Secondary Outcome Measures

Overall response rate (ORR)

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)

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)

time from the date of achievement of a remission until the date of relapse.

Full Information

NCT ID

NCT04351022

First Posted

April 15, 2020

Last Updated

April 21, 2020

Sponsor

The First Affiliated Hospital of Soochow University

1. Study Identification

Unique Protocol Identification Number

NCT04351022

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

Keywords

CD38, CART, AML

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CD38 positive relapsed or refractory acute myeloid leukemia

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

CART-38

Intervention Description

Split intravenous infusion of CART-38 cells [dose escalating infusion of (5-20)x10^6 CART-38 cells/kg].

Primary Outcome Measure Information:

Title

Number of Adverse Events

Description

Adverse events are evaluated with CTCAE V5.0

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Overall response rate (ORR)

Description

Time Frame

2 years

Title

Event-free survival (EFS)

Description

time from enrollment to the date of primary refractory disease, or relapse from CR or CRi, or death from any cause.

Time Frame

2 years

Title

Cumulative incidence of relapse(CIR)

Description

time from the date of achievement of a remission until the date of relapse.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaowen Tang, Ph.D

Phone

(0086)51267781856

xwtang1020@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lei Yu, Ph.D

Phone

(0086)13818629089

ylyh188@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaowen Tang, Ph.D

Organizational Affiliation

The First Affiliated Hospital of Soochow University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Soochow University

City

Suzhou

State/Province

Jiangsu

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaowen Tang, Ph.D

Phone

(0086) 51267781856

xwtang1020@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34034795

Citation

Cui 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.

Results Reference

derived

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

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