NCT02763254

Brief Summary

To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

April 27, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 12, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

April 27, 2016

Results QC Date

February 19, 2019

Last Update Submit

March 12, 2019

Conditions

Hodgkin LymphomaLymphoma, Large B-Cell, DiffusePost-transplant Lymphoproliferative Disorder

Keywords

Epstein-Barr VirusDLBCLPTLDEBVCIVICHLT cell

Outcome Measures

Primary Outcomes (1)

  • Best Overall Response

    Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up.

    1 year

Secondary Outcomes (1)

  • Adverse Events

    1 year

Study Arms (1)

baltaleucel-T

EXPERIMENTAL

Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.

Biological: baltaleucel-T

Interventions

baltaleucel-TBIOLOGICAL

Autologous EBV-specific T cells

baltaleucel-T

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The study will include three primary cohorts, with any of the following EBV+ diseases:
  • Cohort A - DLBCL, 1) in first or subsequent relapse, not eligible for autologous transplantation following salvage therapy OR 2) relapse following autologous transplantation.
  • Cohort B - HL, brentuximab vedotin (BV) treatment failure or unable to tolerate BV.
  • Cohort C - PTLD, rituximab treatment failure.
  • Presence of active lymphoma or active PTLD, based on imaging performed within the previous 3 months.
  • Tumor positive for EBV encoded RNA (EBER) based on report from certified laboratory.
  • Absolute lymphocyte count (ALC) \>500/µL
  • Male or female ≥ 12 years of age
  • Weight ≥ 35 kg
  • Eastern Cooperative Oncology Group (ECOG) performance score 0-2, inclusively or Lansky score ≥ 60, as age appropriate
  • Able to understand and comply with the requirements of the study and to provide written informed consent or age appropriate assent for pediatric patients.

You may not qualify if:

  • Known central nervous system (CNS) lymphoma
  • Primary refractory HL or DLBCL
  • Bulky disease
  • Relapse or progression following previous autologous EBV specific T cell treatment.
  • Use of systemic corticosteroids \> 0.5 mg/kg/day prednisolone or equivalent does of alternative corticosteroid within 10 days prior to obtaining 200 mL starting material
  • Positive for HIV, hepatitis B, hepatitis C, syphilis or human T cell leukemia virus (HTLV).
  • Patient is pregnant or lactating
  • Systemic fungal, bacterial, viral or other infection that is not controlled
  • Prior allogeneic hematopoietic stem cell transplantation (allo HSCT)
  • Known history of primary immunodeficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hodgkin DiseaseLymphoma, Large B-Cell, DiffuseEpstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-HodgkinHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

Title
Dr. Kurt Gunter (Chief Medical Officer)
Organization
Cell Medica
Kurt.Gunter@cellmedica.com
832-581-4480

Study Officials

  • Kurt Gunter, MD

    Cell Medica, Inc

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2016

First Posted

May 5, 2016

Study Start

November 1, 2016

Primary Completion

February 17, 2018

Study Completion

February 17, 2018

Last Updated

March 26, 2019

Results First Posted

March 12, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)