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

Phase 1

• Conditions: Leukemia; Lymphoma
• Interventions: Biological: Anti-CD22-CAR-transduced T cells

• Registration Number: NCT03262298
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-08-14
• Study Start: 2017-08-20
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-25
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-06
• Last Update Posted: 2021-02-09
• Primary Completion: 2021-08-20
• Study Completion: 2022-08-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anti-CD22 CAR-T	Anti-CD22-CAR-transduced T cells	Patients will receive a full dose CART infusion at day 0.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03	2 years

Secondary Outcome Measures

Name	Time	Method
CART cells persistence in vivo	2 years
Overall Complete Remission Rate (ORR)	2 years
Disease response(CR, CRi)	2 years

Trial Locations

Locations (1)

Fengtai District; 🇨🇳 Beijing, Beijing, China