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

NCT ID: NCT03262298

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-20

Study Completion Date

2022-08-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Leukemia Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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anti-CD22 CAR-T

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

Group Type EXPERIMENTAL

Anti-CD22-CAR-transduced T cells

Intervention Type BIOLOGICAL

a single dose of Anti-CD22-CAR-transduced T cells will be infusion after preconditioning.

Interventions

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Anti-CD22-CAR-transduced T cells

a single dose of Anti-CD22-CAR-transduced T cells will be infusion after preconditioning.

Intervention Type BIOLOGICAL

Other Intervention Names

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anti-CD22 CART, CART22

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liangding Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital to Academy of Military Medical Sciences

Locations

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Fengtai District

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liangding Hu, M.D.

Role: CONTACT

+86-010-6694-7107

Facility Contacts

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Role: primary

+8618501002450

Other Identifiers

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307-B-22-CAR-T

Identifier Type: -

Identifier Source: org_study_id

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