Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies
NCT ID: NCT03262298
Last Updated: 2021-02-09
Study Results
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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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2017-08-20
2022-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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anti-CD22 CAR-T
Patients will receive a full dose CART infusion at day 0.
Anti-CD22-CAR-transduced T cells
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Affiliated Hospital to Academy of Military Medical Sciences
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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307-B-22-CAR-T
Identifier Type: -
Identifier Source: org_study_id
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