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

S

Soochow University

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Biological: CART-38

Study type

Interventional

Funder types

Other

Identifiers

NCT04351022
UnicarTherapy2020001

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

6 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

CD38 positive relapsed or refractory acute myeloid leukemia
Experimental group
Treatment:
Biological: CART-38

Trial contacts and locations

0

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Central trial contact

Xiaowen Tang, Ph.D; Lei Yu, Ph.D

Data sourced from clinicaltrials.gov

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