CART-19 Cells For MRD Positive CD19+ ALL (CCFMPCA)

Fujian Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Acute Lymphoblastic Leukemia

Treatments: Biological: CART-19

Study type: Interventional

Funder types: Other

Identifiers

NCT03027739

CART-19-02

Details and patient eligibility

About

CART-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses in highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients who are refractory or at highest risk of relapse as defined by MRD+ status.

Enrollment: 20 estimated patients

Sex: All

Ages: 1 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed written informed consent
• Aged between 1-60 years
• Patients with MRD positive CD19+ ALL
• 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 CART-19 cells.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Arm 1

Experimental group

Description:

CART-19 cells treated

Treatment:

Biological: CART-19