- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03262298
Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies
February 6, 2021 updated by: Affiliated Hospital to Academy of Military Medical Sciences
Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy Targeting CD22 in Treating Patients With B Cell Malignancies
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liangding Hu, M.D.
- Phone Number: +86-010-6694-7107
- Email: huliangding@sohu.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100071
- Recruiting
- Fengtai District
-
Contact:
- Phone Number: +8618501002450
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: anti-CD22 CAR-T
Patients will receive a full dose CART infusion at day 0.
|
a single dose of Anti-CD22-CAR-transduced T cells will be infusion after preconditioning.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Complete Remission Rate (ORR)
Time Frame: 2 years
|
2 years
|
Disease response(CR, CRi)
Time Frame: 2 years
|
2 years
|
CART cells persistence in vivo
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Liangding Chen, M.D., Affiliated Hospital to Academy of Military Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 20, 2017
Primary Completion (Anticipated)
August 20, 2021
Study Completion (Anticipated)
August 20, 2022
Study Registration Dates
First Submitted
August 14, 2017
First Submitted That Met QC Criteria
August 22, 2017
First Posted (Actual)
August 25, 2017
Study Record Updates
Last Update Posted (Actual)
February 9, 2021
Last Update Submitted That Met QC Criteria
February 6, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 307-B-22-CAR-T
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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