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CAR T-cell Therapy

EBV-Specific T-Cell Therapy for Lymphoma (CILESTE Trial)

Phase 1
Recruiting
Led By Bilal Omer, 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 bilirubin ≤ 3x upper limit of normal, AST ≤ 5x upper limit of normal, creatinine ≤ 2x upper limit of normal for age and Hgb ≥ 7.0 (may be a transfused value)
Patients with a Karnofsky/Lansky score of ≥ 50
Must not have
Bulky disease resulting in airway obstruction or risk for airway obstruction with further enlargement.
Current use of systemic corticosteroids (prednisone equivalent >0.5 mg/kg/day)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks (±2 weeks) post infusion
Awards & highlights
No Placebo-Only Group

Summary

This trial is for patients with Hodgkin or non-Hodgkin lymphoma that has come back or has not gone away after treatment, who also show signs of Epstein Barr virus. T cells will be infused that have been genetically modified to target and kill cancer cells infected with EBV. The goal is to find the largest safe dose and evaluate how long the cells can be detected in the blood and what affect they have on cancer.

Who is the study for?
This trial is for individuals with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma, or T/NK-lymphoproliferative disease that persists after treatment. Participants must have certain blood and organ function levels, weigh at least 10 kg, have a life expectancy of over 6 weeks, and not be on systemic steroids or pregnant.
What is being tested?
The study tests different doses of genetically modified T cells (C7R-EBV T cells) designed to last longer in the body and fight EBV-infected tumor cells. The goal is to determine the highest safe dose, how long these cells can be detected in the blood, and their effect on cancer.
What are the potential side effects?
Potential side effects may include immune reactions as the modified T cells attack infected cells. Specific side effects are not listed but could relate to general cell therapy risks such as fever, fatigue, headache, or an allergic reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood tests for liver and kidney function, and hemoglobin levels are within the required limits.
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I can do most activities but may need help.
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My tumor is confirmed to be EBV positive by a pathology test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition is causing or could soon block my airways due to its size.
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I am currently taking a high dose of steroids daily.
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I do not have any ongoing serious infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks (±2 weeks) post infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks (±2 weeks) post infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
1. Dose limiting toxicity rate (DLT) by Common Terminology Criteria for Adverse Events v5.0
Secondary study objectives
1. Response rate by Lymphoma Response to Immunomodulatory Therapy (LYRIC) criteria

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: Arm B: Treatment with lymphodepletion chemotherapyExperimental Treatment2 Interventions
C7R-EBVSTs with lymphodepletion chemotherapy
Group II: Arm A: Treatment without lymphodepletion chemotherapyExperimental Treatment3 Interventions
C7R-EBVSTs Group B will be activated if only limited expansion and clinical efficacy is observed in Group A

Find a Location

Who is running the clinical trial?

Texas Children's HospitalUNKNOWN
1 Previous Clinical Trials
10,000 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,187 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
287 Previous Clinical Trials
81,736 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,030,118 Total Patients Enrolled
Bilal Omer, MDPrincipal InvestigatorBaylor College of Medicine
7 Previous Clinical Trials
275 Total Patients Enrolled

Media Library

C7R-EBV T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04664179 — Phase 1
Hodgkin's Lymphoma Research Study Groups: Arm A: Treatment without lymphodepletion chemotherapy, Arm B: Treatment with lymphodepletion chemotherapy
Hodgkin's Lymphoma Clinical Trial 2023: C7R-EBV T cells Highlights & Side Effects. Trial Name: NCT04664179 — Phase 1
C7R-EBV T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04664179 — Phase 1
~16 spots leftby Apr 2026
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