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Pilot Study of Anti-CD20-CAR-engineered T Cells in Patients With Chemotherapy Resistant or Refractory CD20+ Lymphoma

NCT ID: NCT02965157

Last Updated: 2016-11-16

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma, B-Cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CART20

Group Type EXPERIMENTAL

CART20

Intervention Type BIOLOGICAL

Interventions

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CART20

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Relapsed or refractory CD20+ B-cell lymphoma.
2. Measurable disease.
3. Performance status ECOG 0-2.
4. Age:18-65.
5. Fertile females/males must consent to use contraceptives during participation of the trial.
6. Signed informed consent

Exclusion Criteria

1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
2. Patients with primary CNS lymphoma.
3. Known human immunodeficiency virus (HIV) infection.
4. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
5. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
6. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
7. Patients that do not consent to that tissue and blood samples are stored in a biobank.
8. Pregnancy.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Biohealthcare Biotechnology Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chinese Academy of Medical Sciences Tumor Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Shuting professor Li, doctor

Role: primary

Other Identifiers

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EY201605-19

Identifier Type: -

Identifier Source: org_study_id