NCT02247609

Brief Summary

Currently, a majority of B cell lymphomas cannot be cured by standard chemo-radiotherapy. Most B cell lymphomas express cluster of differentiation antigen 19 (CD19), which represents a very attractive target for chimeric antigen receptor (CAR)-based immune cell therapy. This study will evaluate a novel 4th generation CD19 CAR engineered with a self-withdrawal mechanism (19273-4SCAR) for both efficacy and safety in lymphoma patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2014

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 20, 2014

Status Verified

January 1, 2014

Enrollment Period

2.8 years

First QC Date

September 17, 2014

Last Update Submit

October 16, 2014

Conditions

B-cell Lymphomas

Keywords

B cell lymphomanon-Hodgkin's lymphomaBurkitt lymphomadiffused large B cell lymphomaB cell malignancy

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events.

    Determine the toxicity profile of the 4th generation CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

    2 years.

Secondary Outcomes (3)

  • Survival time of Anti-CD19 CAR T cells in vivo.

    2 years.

  • Response rates to the 4th generation CAR T cells.

    2 years.

  • Survival time of the patients.

    2 years.

Study Arms (1)

CAR T cells

EXPERIMENTAL

Autologous 4th generation anti-CD19-CAR T cells

Genetic: Anti-CD19 CAR T cells

Interventions

Anti-CD19 CAR T cellsGENETIC

Autologous 4th generation withdrawable lentiviral-transduced anti-CD19-CAR T cells

Also known as: 19273-4SCAR
CAR T cells

Eligibility Criteria

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

You may qualify if:

  • Relapsed or refractory CD19(+) B cell lymphoma patients proved by immuno-histochemistry (IHC) or Flow-cytometry.
  • Not eligible for autologous stem-cell transplantation (ASCT) or relapsed after ASCT.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Age≥18.
  • Pulse oximetry of \> 90% on room air.
  • Adequate hepatic function, defined as alanine transaminase (ALT) \<3 x upper limit of normal (ULN), aspartate aminotransferase (AST) \<3 x ULN; serum bilirubin and alkaline phosphatase \<2 x ULN.
  • Adequate renal function, defined as serum creatinine \<2.0mg/dl.
  • Adequate heart function with LVEF≥50%
  • Hb≥80g/L
  • Measurable disease can be identified.
  • Life expectancy ≥3 months.
  • Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 1 year after the study is concluded. The male partner should use a condom.
  • Patients must sign an informed consent.

You may not qualify if:

  • Uncontrolled active infection.
  • Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV).
  • HIV positive
  • Pregnant or lactating.
  • Currently enrolled in another clinical trial.
  • Concurrent use of systemic steroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-CellLymphoma, Non-HodgkinBurkitt Lymphoma

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Officials

  • Jun Zhu, MD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Zhu, MD

CONTACT

+86-10-88196596zj@bjcancer.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 25, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2017

Last Updated

October 20, 2014

Record last verified: 2014-01

Locations

CN(1)