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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

TGF-beta Trial 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.Check my eligibility

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.See study design

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.

TGF-beta Trial 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.

TGF-beta Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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.

TGF-beta 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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,172 Total Patients Enrolled

36 Trials studying Lymphoma

1,059 Patients Enrolled for Lymphoma

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,809 Total Patients Enrolled

24 Trials studying Lymphoma

846 Patients Enrolled for Lymphoma

The Methodist Hospital Research InstituteOTHER

271 Previous Clinical Trials

80,367 Total Patients Enrolled

31 Trials studying Lymphoma

956 Patients Enrolled for Lymphoma

Media Library

TGFbeta resistant LMP-specific CTLs (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00368082 — Phase 1

Lymphoma Research Study Groups: TGFbeta resistant LMP-specific CTLs

Lymphoma Clinical Trial 2023: TGFbeta resistant LMP-specific CTLs Highlights & Side Effects. Trial Name: NCT00368082 — Phase 1

TGFbeta resistant LMP-specific CTLs (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00368082 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an ongoing recruitment process for this research project?

"Unfortunately, this clinical trial has concluded its recruitment phase according to information posted on the site. The investigation was first published in April of 2006 and last amended in December 2021. Despite closing enrollment for this particular study, there are still 1774 other trials actively recruiting new participants at present time."

Answered by AI

Could you explain the potential risks of utilizing TGFbeta resistant LMP-specific CTLs in a medical setting?

"Due to the minimal safety and efficacy data available, our team has assigned TGFbeta resistant LMP-specific CTLs a score of 1 on a scale from 1 to 3."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Tumor-specific T-cells Engineered to Overcome Tumor Immune Evasion Induce Clinical Responses in Patients with Relapsed Hodgkin Lymphoma

Bollard, Catherine M., Tamara Tripic, Conrad Russell Cruz, Gianpietro Dotti, Stephen Gottschalk, Vicky Torrano, Olga Dakhova, et al.. 2018. “Tumor-specific T-cells Engineered to Overcome Tumor Immune Evasion Induce Clinical Responses in Patients with Relapsed Hodgkin Lymphoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2017.74.3179.

clinicaltrials.govStudy

Autologous/Allogeneic TGFbeta-resistant LMP-specific CTL, Lymphoma (TGF-beta)

Helen Heslop 2006. "Autologous/Allogeneic TGFbeta-resistant LMP-specific CTL, Lymphoma (TGF-beta)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00368082.

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