- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02965157
Pilot Study of Anti-CD20-CAR-engineered T Cells in Patients With Chemotherapy Resistant or Refractory CD20+ Lymphoma
November 14, 2016 updated by: Beijing Biohealthcare Biotechnology Co.,Ltd
Chimeric antigen receptor (CAR) T cells targeting CD20 will be evaluated for safety and efficacy in patients with CD20+ B cell lymphoma.
The CAR consists of a CD20 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28.
Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector.
Prior to T cell infusion, the patients will be subjected to preconditioning treatment.
After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
15
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 Locations
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-
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Beijing, China
- Recruiting
- Chinese Academy of Medical Sciences Tumor Hospital
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Contact:
- Shuting professor Li, doctor
- Phone Number: 8610-87788495
- Email: csmocaco@126.com
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Principal Investigator:
- Yuankai professor Shi, doctor
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Sub-Investigator:
- Shengyu professor Zhou, doctor
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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:
- Relapsed or refractory CD20+ B-cell lymphoma.
- Measurable disease.
- Performance status ECOG 0-2.
- Age:18-65.
- Fertile females/males must consent to use contraceptives during participation of the trial.
- Signed informed consent
Exclusion Criteria:
- Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
- Patients with primary CNS lymphoma.
- Known human immunodeficiency virus (HIV) infection.
- Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
- Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
- Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
- Patients that do not consent to that tissue and blood samples are stored in a biobank.
Pregnancy.
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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 |
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Experimental: CART20
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
all cause mortality
Time Frame: one year
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
August 1, 2016
Primary Completion (Anticipated)
January 1, 2018
Study Registration Dates
First Submitted
August 31, 2016
First Submitted That Met QC Criteria
November 14, 2016
First Posted (Estimate)
November 16, 2016
Study Record Updates
Last Update Posted (Estimate)
November 16, 2016
Last Update Submitted That Met QC Criteria
November 14, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EY201605-19
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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