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

Primary Purpose

Lymphoma, B-Cell

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CART20
Sponsored by
Beijing Biohealthcare Biotechnology Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

    -

Sites / Locations

  • Chinese Academy of Medical Sciences Tumor HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CART20

Arm Description

Outcomes

Primary Outcome Measures

all cause mortality

Secondary Outcome Measures

Full Information

First Posted
August 31, 2016
Last Updated
November 14, 2016
Sponsor
Beijing Biohealthcare Biotechnology Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02965157
Brief Title
Pilot Study of Anti-CD20-CAR-engineered T Cells in Patients With Chemotherapy Resistant or Refractory CD20+ Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Biohealthcare Biotechnology Co.,Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CART20
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CART20
Primary Outcome Measure Information:
Title
all cause mortality
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Facility Information:
Facility Name
Chinese Academy of Medical Sciences Tumor Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuting professor Li, doctor
Phone
8610-87788495
Email
csmocaco@126.com
First Name & Middle Initial & Last Name & Degree
Yuankai professor Shi, doctor
First Name & Middle Initial & Last Name & Degree
Shengyu professor Zhou, doctor

12. IPD Sharing Statement

Learn more about this trial

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

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