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CAR T-cell Therapy

Cytotoxic T Cells for Lymphoma (ALCI2 Trial)

Phase 1
Waitlist Available
Led By Catherine Bollard, MD
Research Sponsored by Catherine Bollard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tumor tissue EBV positive
Patients with a Karnofsky/Lansky score of > 50
Must not have
Donors who are HIV positive
Patients with GVHD > Grade II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a new experimental therapy, third party LMP specific cytotoxic T lymphocytes (CTLs), can prevent or treat EBV Disorder including either Hodgkin Lymphoma or non-Hodgkin Lymphoma or Lymphoepithelioma or severe chronic active EBV infection syndrome (SCAEBV) or Leiomyosarcoma which has come back or has not gone away after treatment, including the best treatment.

Who is the study for?
This trial is for people of any age or sex with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma, other related diseases, or Severe Chronic EBV. They must have a life expectancy over 6 weeks and meet certain health criteria like normal liver function and adequate hemoglobin levels. Pregnant women and patients with severe graft-versus-host disease are excluded.
What is being tested?
The study tests if special immune cells called third party LMP specific cytotoxic T lymphocytes (CTLs) can prevent or treat relapsed EBV-related cancers by targeting the virus in cancer cells. Group A includes those in remission; Group B has detectable disease after stem cell transplant.
What are the potential side effects?
As this is an experimental therapy not yet approved by the FDA, potential side effects aren't fully known but may include typical immune response reactions such as fever, fatigue, and possible complications from targeting healthy cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is positive for the Epstein-Barr virus.
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I am mostly able to care for myself but may need help.
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My kidney function, measured by creatinine, is less than twice the normal level for my age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV positive.
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My graft-versus-host disease is more severe than Grade II.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with dose limiting toxicity (DLT)
Secondary study objectives
Survival and Immune Function of LMP-specific CTLs
Other study objectives
To obtain preliminary information on the safety and response to an extended dosage regimen.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: LMP1/2 CTLs (Group B)Experimental Treatment1 Intervention
Patients receiving CTLs in relapse following allogeneic stem cell transplant
Group II: LMP1/2 CTLs (Group A)Experimental Treatment1 Intervention
Patients receiving CTLs as adjunctive therapy following allogeneic stem transplant

Find a Location

Who is running the clinical trial?

Catherine BollardLead Sponsor
13 Previous Clinical Trials
307 Total Patients Enrolled
Catherine Bollard, MDPrincipal InvestigatorCNMC
6 Previous Clinical Trials
79 Total Patients Enrolled

Media Library

LMP1/2 CTLs (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01956084 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: LMP1/2 CTLs (Group A), LMP1/2 CTLs (Group B)
Non-Hodgkin's Lymphoma Clinical Trial 2023: LMP1/2 CTLs Highlights & Side Effects. Trial Name: NCT01956084 — Phase 1
LMP1/2 CTLs (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01956084 — Phase 1
~2 spots leftby Nov 2025
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