NCT02965157

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Last Updated

November 16, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

August 31, 2016

Last Update Submit

November 14, 2016

Conditions

Lymphoma, B-Cell

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    one year

Study Arms (1)

CART20

EXPERIMENTAL
Biological: CART20

Interventions

CART20BIOLOGICAL
CART20

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences Tumor Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

November 16, 2016

Study Start

August 1, 2016

Primary Completion

January 1, 2018

Last Updated

November 16, 2016

Record last verified: 2016-08

Locations

CN(1)