Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Status and phase: Unknown; Phase 1

Conditions: Leukemia

Treatments: Biological: allogeneic CART-19

Study type: Interventional

Funder types: Other

Identifiers

NCT02799550

CART-ALL-2015

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19) infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)

Full description

The relapsed and/or refractory B-ALL patients will receive infusions of allogeneic CART-19 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily vindesine, mitoxantrone, cyclophosphamide, pegaspargase and dexamethasone, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.

Enrollment: 10 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 60 years
• Patient with relapsed and/or refractory CD19 positive B-cell acute lymphoblastic leukemia (B-ALL)
• 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
• CD19 negative B-cell leukemia
• Any uncontrolled active medical disorder that would preclude participation as outlined

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

allogeneic CART-19

Experimental group

Description:

infusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)

Treatment:

Biological: allogeneic CART-19