CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.

Shanghai Unicar-Therapy Bio-medicine Technology

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Leukemia, B-cell

Treatments: Biological: CART-19/22

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03614858

UnicarTherapy201807

Details and patient eligibility

About

This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Full description

The patients will receive infusion of CART cells targeting CD19 and CD22 to confirm the safety and efficacy of CD19/CD22 CART Cells in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients with CD19+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to <2 year). The study will enroll 20 evaluable patients as follows:
• Age 6-65 years.
• Left ventricular ejection fractions≥ 0.5 by echocardiography.
• Creatinine < 1.6 mg/dL.
• Aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal.
• Bilirubin <2.0 mg/dL.
• Karnofsky performance status ≥ 60
• Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion criteria

• Pregnant or lactating women.
• Uncontrolled active infection.
• Active hepatitis B or hepatitis C infection.
• Class III/IV cardiovascular disability according to the New York Heart Association Classification.
• HIV infection.
• Patients with history of seizure
• Active central nervous system leukemia

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

Cohort 1

Experimental group

Description:

Experimental: Cohort 1 Intervention: Biological: CART-19/22 This cohort will determine the safety and efficacy of targeted CD19/CD22 chimeric Antigen Receptor Engineered T Cell Immunotherapy (CART) in the Treatment of CD19/CD22 Positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Treatment:

Biological: CART-19/22