Allogeneic CART-33 for Relapsed/Refractory CD33+ AML

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Status and phase: Unknown; Phase 1

Conditions: Relapsed and/or Refractory CD33+ AML

Treatments: Biological: allogeneic CART-33

Study type: Interventional

Funder types: Other

Identifiers

NCT02799680

CART-AML-2015

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33) infusions in patients with relapsed / refractory acute myeloid leukemia (AML).

Full description

The relapsed and/or refractory AML patients will receive infusions of allogeneic CART-33 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily idarubicin and cytarabine, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.

Enrollment: 12 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 50 years
• Patient with relapsed and/or refractory CD33 positive acute myeloid leukemia (AML)
• Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion criteria

• Previous treatment with investigational gene or cell therapy medicine products
• CD33 negative leukemia
• Any uncontrolled active medical disorder that would preclude participation as outlined
• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

allogeneic CART-33

Experimental group

Description:

infusions of allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33)

Treatment:

Biological: allogeneic CART-33