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

Lymphoma Clinical Trial

Official title:

Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy Targeting CD22 in Treating Patients With B Cell Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03262298
• Other study ID #: 307-B-22-CAR-T
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 20, 2017
• Est. completion date: August 20, 2022

Study information

• Verified date: February 2021
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Liangding Hu, M.D.
• Phone: +86-010-6694-7107
• Email: huliangding[@]sohu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 20, 2022
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	Fengtai District	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03		2 years
Secondary	Overall Complete Remission Rate (ORR)		2 years
Secondary	Disease response(CR, CRi)		2 years
Secondary	CART cells persistence in vivo		2 years