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CAR T-cell Therapy

TGFbeta-resistant Immune Cells for Lymphoma (TGF-beta Trial)

Phase 1

Waitlist Available

Led By Helen E Heslop, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a Karnofsky score of 50 or greater.

If post allogeneic SCT must not have less than 50% donor chimerism in either peripheral blood or bone marrow

Must not have

Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.

Patients with a severe intercurrent infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is researching a new experimental therapy using special immune system cells to treat patients with a type of lymph gland cancer that has come back or not gone away after treatment.

Who is the study for?

This trial is for individuals with EBV-positive lymphoma or lymphoepithelioma, regardless of age or sex. They should have a life expectancy of at least 6 weeks post-CTL infusion, be able to perform daily activities (Karnofsky score ≥50), and have certain levels of blood and liver function. It's not for those with severe infections, significant GVHD after transplant, HIV positive status, or pregnant women.

What is being tested?

The study tests TGFbeta-resistant LMP-specific CTLs in patients whose lymphoma has returned or persisted despite treatment. The goal is to find the highest safe dose, understand side effects, and see if this gene-modified therapy can fight cancer by targeting EBV-infected cells that evade the immune system.

What are the potential side effects?

While specific side effects are not listed here, similar therapies often involve immune reactions like fever or fatigue; organ inflammation; possible complications from cell infusions; and risks associated with genetic modifications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly able to take care of myself.

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After my bone marrow transplant, more than half of my cells are from the donor.

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I have EBV-positive lymphoma or related conditions confirmed by a tissue sample.

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I have had a stem cell transplant for EBV-related cancer.

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My kidney function, measured by creatinine, is within twice the normal limit 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 not pregnant and understand the need for contraception during the study.

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I do not have a severe ongoing infection.

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I do not have severe graft-versus-host disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 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

Safety and MTD of 2 IV injections of autologous/syngeneic or allogeneic TGFb resistant LMP-specific cytotoxic T-lymphocytes.

Secondary study objectives

Determine anti-viral and anti-tumor effects of TGFbeta resistant LMP-specific CTL.

Survival and immune function of TGFbeta-resistant LMP-specific cytotoxic T-lymphocytes.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TGFbeta resistant LMP-specific CTLsExperimental Treatment1 Intervention

CTLs be given by intravenous injection over 1-10 minutes through either a peripheral or a central line. If patients with active disease have stable disease or a partial response at their 6 week or subsequent evaluations they will be eligible to receive up to 6 additional doses of CTLs at 1-2 monthly intervals-each of which will consist of the same cell number as their second injection.

0 / 8Eligibility criteria met