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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks (±2 weeks) post infusion

Awards & highlights

CILESTE Trial 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.Check my eligibility

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.See study design

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.

CILESTE Trial 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.

CILESTE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks (±2 weeks) post infusion

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

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

Primary outcome measures

1. Dose limiting toxicity rate (DLT) by Common Terminology Criteria for Adverse Events v5.0

Secondary outcome measures

1. Response rate by Lymphoma Response to Immunomodulatory Therapy (LYRIC) criteria

CILESTE 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteOTHER

271 Previous Clinical Trials

80,331 Total Patients Enrolled

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,208 Total Patients Enrolled

Bilal Omer, MDPrincipal InvestigatorBaylor College of Medicine

7 Previous Clinical Trials

272 Total Patients Enrolled

Media Library

C7R-EBV T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04664179 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: Arm A: Treatment without lymphodepletion chemotherapy, Arm B: Treatment with lymphodepletion chemotherapy

Non-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

Frequently Asked Questions

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

Is enrollment still available in this clinical trial?

"Affirmative. Clinicaltrials.gov corroborates that this research trial is currently recruiting participants, with an initial posting date of October 1st 2022 and a recent edit on August 30th 2022. There are 44 slots available at two different locations."

Answered by AI

Has the federal regulatory agency sanctioned Dose Level 3B?

"Since there is relatively little data on the safety and efficacy of Dose Level 3B, our team at Power rated it as a 1 out of 3. This assessment is due to this being an early Phase 1 trial."

Answered by AI

What is the aggregate of participants involved in this research?

"Affirmative. The clinicaltrials.gov website reveals that this research study is currently enrolling participants, with the initial posting on October 1st 2022 and the most recent update being August 30th 2022. 44 people are required to participate across 2 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma

Bilal Omer 2022. "EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04664179.

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