NCT04351022

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

4.5 years

First QC Date

April 15, 2020

Last Update Submit

April 21, 2020

Conditions

Acute Myeloid Leukemia

Keywords

CD38, CART, AML

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    Adverse events are evaluated with CTCAE V5.0

    12 months

Secondary Outcomes (3)

  • Overall response rate (ORR)

    2 years

  • Event-free survival (EFS)

    2 years

  • Cumulative incidence of relapse(CIR)

    2 years

Study Arms (1)

CD38 positive relapsed or refractory acute myeloid leukemia

EXPERIMENTAL
Biological: CART-38

Interventions

CART-38BIOLOGICAL

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

CD38 positive relapsed or refractory acute myeloid leukemia

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

Related Publications (2)

  • Cui 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: 36524116DERIVED

  • 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.

    PMID: 34034795DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Xiaowen Tang, Ph.D

    The First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaowen Tang, Ph.D

CONTACT

(0086)51267781856xwtang1020@163.com

Lei Yu, Ph.D

CONTACT

(0086)13818629089ylyh188@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 17, 2020

Study Start

July 1, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2023

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)