CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 74 enrolled
Drug / intervention
LMP1/2 CTLs (ALCI - Group A) +8 morebiological
Likely dose
LMP1/2 CTLs or LMP2 CTLs, 2×10^7 cells/m² on Day 0 and 2×10^7–2×10^8 cells/m² on Day 14 (depending on dose level), two injections 14 days apartAI-extracted
Key inclusion· 8
  • EBV-positive Hodgkin lymphoma, non-Hodgkin lymphoma, lymphoepithelioma, leiomyosarcoma, EBV-associated T/NK-lymphoproliferative disease, or Severe Chronic EBV (SCAEBV)
  • In second or subsequent relapse; or first relapse/active disease if immunosuppressive chemotherapy contraindicated; or multiply relapsed patients in remission with high relapse risk; or primary disease/first remission if chemotherapy contraindicated (e.g., post-transplant Hodgkin disease, Richter transformation)
  • In remission or with minimal residual disease after autologous or syngeneic stem cell transplant
  • In remission or with detectable disease after allogeneic stem cell transplant
Key exclusion· 8
  • Life expectancy <6 weeks
  • Karnofsky/Lansky score <50
  • Severe intercurrent infection
  • Bilirubin >3× normal, AST >5× normal, or abnormal prothrombin time

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00062868
NCT00062868Phase 1Completed

Administration of LMP-Specific Cytotoxic T-Lymphocytes to Patients With Relapsed EBV-Positive Lymphoma (ALCI) / Previously Known as: Administration of Neomycin Resistance Gene Marked LMP2A-Specific Cytotoxic T-Lymphocytes to Patents With Relapsed EBV-Positive Lymphoma (ALASCAR)

Baylor College of Medicine·interventional·Posted Jun 18, 2003·Updated Jun 9, 2020

In Brief

A Phase 1 clinical trial evaluating LMP1/2 CTLs (ALCI - Group A), LMP1/2 CTLs (ALCI - Group B), and 7 other interventions for Hodgkin Disease and 3 related conditions. Completed, enrolled 74 participants across 2 sites.

Detailed Summary

This protocol is broken up into 2 portions to determine the maximum tolerated dose for treating patients with a type of lymph gland disease. The 1st portion, called ALASCER are for people with a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma or Lymphoepithelioma which has returned or may return or has not gone away after treatment, including the best treatment we know for Lymphoma. While the 2nd portion (ALCI) also includes Lymphoepithelioma, severe chronic active EBV (SCAEBC), and leiomyosarcoma. Some patients with Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma, suggesting that it may play a role in causing Lymphoma. The cancer cells (in lymphoma) and some B cells (in SCAEBV) infected by EBV are able to hide from the body's immune system and escape destruction. Investigators want to see if special white blood cells, called T cells, that have been trained to kill EBV infected cells can survive in your blood and affect the tumor. The investigators have used this sort of therapy to treat a different type of cancer that occurs after bone marrow or solid organ transplant called post transplant lymphoma. In this type of cancer the tumor cells have 9 proteins made by EBV on their surface. The investigators grew T cells in the laboratory that recognized all 9 proteins and were able to successfully prevent and treat post transplant lymphoma. However in Hodgkin disease and non-Hodgkin Lymphoma and SCAEBV, the tumor cells and B cells only express 2 EBV proteins. In a previous study we made T cells that recognized all 9 proteins and gave them to patients with Hodgkin disease. Some patients had a partial response to this therapy but no patients had a complete response. Investigators think one reason may be that many of the T cells reacted with proteins that were not on the tumor cells. In this present study we are trying to find out if we can improve this treatment by growing T cells that only recognize one of the proteins expressed on infected EBV Lymphoma cells called LMP-2a, and B cells called LMP1 and LMP2. These special T cells are called LMP specific cytotoxic T-lymphocytes (CTLs). The purpose of the study is to find the largest safe dose of LMP specific cytotoxic T cells, to learn what the side effects are and to see whether this therapy might help patients with Hodgkin disease, non-Hodgkin Lymphoma, Lymphoepithelioma, SCAEBV or leiomyosarcoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 18, 2003
Enrollment StartSep 1, 2003
Primary CompletionApr 1, 2014
Study CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 10.6 yearsPosted 23.0 years ago

Interventions

LMP1/2 CTLs (ALCI - Group A)biological

Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2 x 10\^7 cells/m2; Day 14: 2 x 10\^7 cells/m2 Dose Level Two Day 0: 2x10\^7 cells/m2; Day 14: 1x10\^8 cells/m2 Dose Level Three Day 0: 1x10\^8 cells/m2; Day 14: 2x10\^8 cells/m2

LMP1/2 CTLs (ALCI - Group B)biological

Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2x10\^7 cells/m2; Day 14: 2x10\^7 cells/m2 Dose Level Two Day 0: 2x10\^7 cells/m2; Day 14: 1x10\^8 cells/m2 Dose Level Three Day 0: 1x10\^8 cells/m2; Day 14: 2x10\^8 cells/m2

LMP1/2 CTLs (ALCI - Group C)biological

Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2x10\^7 cells/m2; Day 14: 2x10\^7 cells/m2 Dose Level Two Day 0: 2x10\^7 cells/m2; Day 14: 1x10\^8 cells/m2 Dose Level Three Day 0: 1x10\^8 cells/m2; Day 14: 2x10\^8 cells/m2

LMP2 CTLs (ALSCER - Group A)biological

Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2 x 10\^7 cells/m2; Day 14: 2 x 10\^7 cells/m2 Dose Level Two Day 0: 2x10\^7 cells/m2; Day 14: 1x10\^8 cells/m2 Dose Level Three Day 0: 1x10\^8 cells/m2; Day 14: 2x10\^8 cells/m2

LMP2 CTLs (ALSCER - Group B)biological

Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2x10\^7 cells/m2; Day 14: 2x10\^7 cells/m2 Dose Level Two Day 0: 2x10\^7 cells/m2; Day 14: 1x10\^8 cells/m2 Dose Level Three Day 0: 1x10\^8 cells/m2; Day 14: 2x10\^8 cells/m2

LMP2 CTLs (ALSCER - Group C)biological

Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2x10\^7 cells/m2; Day 14: 2x10\^7 cells/m2 Dose Level Two Day 0: 2x10\^7 cells/m2; Day 14: 1x10\^8 cells/m2 Dose Level Three Day 0: 1x10\^8 cells/m2; Day 14: 2x10\^8 cells/m2

LMP1/2 CTLs (ALCI - Expansion - Group A)biological

Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2 x 10\^7 cells/m2; Day 14: 2 x 10\^7 cells/m2

LMP1/2 CTLs (ALCI - Expansion Group B)biological

Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2x10\^7 cells/m2; Day 14: 2x10\^7 cells/m2

LMP1/2 CTLs (ALCI - Expansion Group C)biological

Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2x10\^7 cells/m2; Day 14: 2x10\^7 cells/m2