Status:
UNKNOWN
Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies
Lead Sponsor:
Affiliated Hospital to Academy of Military Medical Sciences
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 r...
Eligibility Criteria
Inclusion
- Age: 18-65 years
- Patients with Cluster of Differentiation 22(CD22) positive B cell malignancies as confirmed by flow cytometry
- Refractory or relapsed B cell-acute lymphoblastic leukemia
- No available curative treatment options (such as hematopoietic stem cell transplantation)
- Stage III-IV disease
- Creatinine \< 2.5 mg/dl
- Aspartate transaminase-alanine transaminase ratio \< 3x normal
- Bilirubin \< 2.0 mg/dl
- Karnofsky performance status \>= 60
- Expected survival time \> 3 months
- Adequate venous access for apheresis
- Ability to understand and provide informed consent
Exclusion
- Pregnant or lactating women
- Patients requiring T cell immunosuppressive therapy
- Active central nervous system leukemia
- Any concurrent active malignancies
- Patients with a history of a seizure disorder or cardiac disorder
- Previous treatment with any immunotherapy products
- Patients with human immunodeficiency virus, hepatitis B or C infection
- Uncontrolled active infection
Key Trial Info
Start Date :
August 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 20 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03262298
Start Date
August 20 2017
End Date
August 20 2022
Last Update
February 9 2021
Active Locations (1)
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1
Fengtai District
Beijing, Beijing Municipality, China, 100071