Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Lymphoma; Leukemia

Treatments: Biological: Anti-CD22-CAR-transduced T cells

Study type: Interventional

Funder types: Other

Identifiers

NCT03262298

307-B-22-CAR-T

Details and patient eligibility

About

The study will evaluate safety and efficacy of the CD22-targeted chimeric antigen receptor modified-T cell(CAR-T) cells in the treatment of B-cell Malignancies.

Full description

Clinical success with chimeric antigen receptor (CAR)- based immunotherapy for leukemia has been accompanied by the associated finding that antigen-escape variants of the disease are responsible for relapse. Despite anti-CD19 CAR-T exhibited the ability to re-induce remissions for many patients with relapsed and refractory B cell malignancies, a part of those patients will relapse with CD19-negative malignancies. CD22 is a type I transmembrane protein expressed on most mature B lymphocyte in the B cell malignancies，and plays a significant role in signal transduction pathway. The investigators design and conduct this trial to test the safety and effectiveness of CD22-targeted CAR-T.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: 18-65 years
2. Patients with Cluster of Differentiation 22(CD22) positive B cell malignancies as confirmed by flow cytometry
3. Refractory or relapsed B cell-acute lymphoblastic leukemia
4. No available curative treatment options (such as hematopoietic stem cell transplantation)
5. Stage III-IV disease
6. Creatinine < 2.5 mg/dl
7. Aspartate transaminase-alanine transaminase ratio < 3x normal
8. Bilirubin < 2.0 mg/dl
9. Karnofsky performance status >= 60
10. Expected survival time > 3 months
11. Adequate venous access for apheresis
12. Ability to understand and provide informed consent

Exclusion criteria

1. Pregnant or lactating women
2. Patients requiring T cell immunosuppressive therapy
3. Active central nervous system leukemia
4. Any concurrent active malignancies
5. Patients with a history of a seizure disorder or cardiac disorder
6. Previous treatment with any immunotherapy products
7. Patients with human immunodeficiency virus, hepatitis B or C infection
8. Uncontrolled active infection

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

anti-CD22 CAR-T

Experimental group

Description:

Patients will receive a full dose CART infusion at day 0.

Treatment:

Biological: Anti-CD22-CAR-transduced T cells