Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies
Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy Targeting CD22 in Treating Patients With B Cell Malignancies
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 leukemia
Started Aug 2017
Typical duration for phase_1 leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2017
CompletedStudy Start
First participant enrolled
August 20, 2017
CompletedFirst Posted
Study publicly available on registry
August 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2022
CompletedFebruary 9, 2021
February 1, 2021
4 years
August 14, 2017
February 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03
2 years
Secondary Outcomes (3)
Overall Complete Remission Rate (ORR)
2 years
Disease response(CR, CRi)
2 years
CART cells persistence in vivo
2 years
Study Arms (1)
anti-CD22 CAR-T
EXPERIMENTALPatients will receive a full dose CART infusion at day 0.
Interventions
a single dose of Anti-CD22-CAR-transduced T cells will be infusion after preconditioning.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fengtai District
Beijing, Beijing Municipality, 100071, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liangding Chen, M.D.
Affiliated Hospital to Academy of Military Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2017
First Posted
August 25, 2017
Study Start
August 20, 2017
Primary Completion
August 20, 2021
Study Completion
August 20, 2022
Last Updated
February 9, 2021
Record last verified: 2021-02