A Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma

Army Medical University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Lymphoma; Leukemia

Treatments: Biological: Chimeric Antigen Receptor Modified T cells Targeting CD19

Study type: Interventional

Funder types: Other

Identifiers

NCT02349698

TMMU-BTC-001

Details and patient eligibility

About

The main purpose of this research is to verify the safety of CD19 targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.

Full description

Nowadays refractory or relapsed leukemia/lymphoma lacks effective treatment. Innovative therapy is urgently required. Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. To design better CAR T cells, we have developed new CD19 CARs. Preclinical studies have demonstrated effective killing of CD19 target cells. In this study, the CD19 CARs, will be evaluated in CD19 positive leukemia/lymphoma patients. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Enrollment: 45 estimated patients

Sex: All

Ages: 4 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphocytic leukemia(CLL) and non-hodgkin lymphoma.
2. KPS>60.
3. Life expectancy>3 months.
4. Gender unlimited, age from 4 years to 75 years.
5. Disease progresses but reserves reaction to recent treatments.
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.

Exclusion criteria

1. HIV affected.
2. Patients are allergic to cytokines.
3. Central nervous system leukemia within 28 days.
4. Uncontrolled active infection.
5. Acute or chronic GVHD.
6. Treated with T cell inhibitor.
7. Pregnancy and nursing females.
8. Other situations we think improper for the research.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Acute Lymphoblastic Leukemia

Other group

Description:

Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells targeting CD19.

Treatment:

Biological: Chimeric Antigen Receptor Modified T cells Targeting CD19

Chronic Lymphcytic Leukemia

Other group

Description:

Chronic lymphocytic leukemia with chimeric antigen receptor modified T cells targeting CD19.

Treatment:

Biological: Chimeric Antigen Receptor Modified T cells Targeting CD19

Non-Hodgkin Lymphoma

Other group

Description:

Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells targeting CD19.

Treatment:

Biological: Chimeric Antigen Receptor Modified T cells Targeting CD19