CD123/CLL1 CAR-T Cells for R/R AML (STPHI_0001)

F

Fujian Medical University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Relapsed/Refractory AML

Treatments

Biological: CD123/CLL1 CAR-T Cells

Study type

Interventional

Funder types

Other

Identifiers

NCT03631576
CART-19-04

Details and patient eligibility

About

The treatment options for relapse/refractory B-cell acute myeloid leukemia(AML)are limited.CD123/CLL1 CAR-T Cells may have a permanent anti-tumor effect and became very attractive. This study aims to assess the safety and toxicity of CD123/CLL1 CAR-T Cells to patients with relapse/refractory AML.

Enrollment

20 estimated patients

Sex

All

Ages

Under 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signed written informed consent
  • Aged < 70 years
  • Patients with relapsed/refractory AML
  • Cardiac: Left ventricular ejection fraction ≥ 50%
  • Adequate renal and hepatic function
  • Performance status: Karnofsky ≥ 70%

Exclusion criteria

  • Pregnant or lactating females.
  • Any co-morbidity precluding the administration of CD123/CLL1 CAR-T Cells.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Arm 1
Experimental group
Description:
CD123/CLL1 CAR-T Cells treat
Treatment:
Biological: CD123/CLL1 CAR-T Cells

Trial contacts and locations

1

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Central trial contact

Jianda Hu, Prof.M.D.Ph.D

Data sourced from clinicaltrials.gov

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