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

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