3rd Party LMP1/2-Specific Cytotoxic T Lymphocytes for EBV-Associated Lymphoma

NCT02057445 | Completed Phase 1 DMC

• 1 other identifier: NYMC-561
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

The administration of allogeneic third party derived LMP specific-CTLs (special peripheral blood cells from another person) that are made specific to fight EBV infection) in Children, Adolescents and Young Adults (CAYA) with EBV-associated refractory or relapsed lymphoma will be feasible ( able to be done), safe and well tolerated (no unexpected serious events will occur). In addition, potential donors who are EBV positive will be enrolled to donate peripheral blood to help build a bank of these specific EBV fighting cell lines.

Conditions

Non-Hodgkins Lymphoma; Hodgkins Lymphoma; Lymphoproliferative Disorder

Keywords

cellular therapy; lymphoma; lymphoproliferative disorder

Outcome Measures

Primary Outcomes (2)

• To determine the safety of giving 3rd party EBV-CTLs

  Patients will be monitored for any unexpected adverse events related to investigational product.

  1 year

• To develop a third party bank of LMP-specific CTL

  EBV positive donors will be asked to provide an extra sample of peripheral blood to build a donor bank of EBV-CTLs for this protocol and future use.

  on going

Secondary Outcomes (1)

• To measure the response rate

  1 year

Study Arms (2)

Recipient

EXPERIMENTAL

EBV+ patients will receive 3rd party LMP-CTLs for treatment of EBV infection and/or disease

Drug: EBV CTL's

Donor

OTHER

Healthy donors who are EBV+ will be asked to donate 60-120 ml of peripheral blood for development of cell lines to be stored for cell line bank.

Other: Peripheral Blood Donor

Interventions

EBV CTL's DRUG

Eligible patients with a matched cell line will be infused with 3rd party CTLs and monitored for adverse events and response. Patients who show a response and tolerate the infusion well may receive up to 5 infusions total 4-6 weeks apart.

Recipient

Peripheral Blood Donor OTHER

Donors who are EBV+ and meet the eligibility criteria will be consented to provide 60-120 ml peripheral blood once for future use for this and other clinical trials using 3rd party CTLs.

Donor

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be at least 1 year of age.
• Patient or the patient's legally authorized guardian must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects), and must sign an informed consent in accordance with the institutional policies approved by the U.S. Department of Health and Human Services.
• Patients should have been off other investigational therapy for one month prior to entry in this study.
• Patient must have adequate organ function as below:
• Adequate renal function defined as:
• Serum creatinine \<2.0 x normal, or
• Creatinine clearance or radioisotope GFR \> 40 ml/min/m2 or \>60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range
• Adequate liver function defined as:
• Total bilirubin \<2.0 x normal; and
• SGOT (AST) or SGPT (ALT) \<5.0 x normal
• Adequate pulmonary function defined as:
• \- Pulse oximetry \>94% in room air. Lansky (\< 16yr) or Karnofsky (\> 16 yrs) performance status ≥ 50% Life expenctancy ≥ 6 weeks. Women of child bearing age require a negative urine pregnancy test. Clinical status at enrollment to allow tapering of steroids to less than 0.5mg/kg/day prednisone at time of treatment.
• Disease Status (Eligibility) 4.5.1 Any patient, with one or more of the following EBV-positive type II latency or associated disorders, regardless of the histological subtype: Hodgkin lymphoma Non-Hodgkin lymphoma Lymphoproliferative disorder Severe chronic active EBV infection syndrome (SCAEBV), defined as high EBV viral load in plasma or PBMC (\> 4000 genomes per μg PBMC DNA) and/or biopsy tissue positive for EBV
• The disease needs to be in one of the following stages:
• At diagnosis who would be unable to receive conventional chemotherapy or in first relapse AND the patient is not a candidate for HSCT Partial response after conventional therapy. Refractory to conventional therapy for his/her condition. In second or subsequent relapse. Residual disease after autologous, syngeneic or allogeneic HSCT.

You may not qualify if:

• Currently receiving any investigational agents or have received any tumor vaccines within previous 4 weeks.
• Active acute grade III-IV graft-versus-host disease. Severe refractory intercurrent infection other than EBV. Received alemtuzumab or other anti-Tcell antibody within 28 days. HIV seropositivity. Pregnancy (due to unknown effects of this therapy on a fetus) or lactation. Patients with PTLD post solid organ transplantation eligible for the COG PTLD LMP/CTL protocol.

Sponsors & Collaborators

• New York Medical College: lead
• Children's National Research Institute: collaborator
• Baylor College of Medicine: collaborator
• M.D. Anderson Cancer Center: collaborator
• University of Michigan: collaborator
• University of Utah: collaborator
• City of Hope Medical Center: collaborator
• Ohio University: collaborator
• Johns Hopkins University: collaborator

Study Sites (2)

Children's National Medical Center

Washington D.C., District of Columbia, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease; Lymphoproliferative Disorders; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mitchell Cairo, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

• Catherine Bollard, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 7, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12

Locations

US (2)