EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma
CILESTE
Constitutive IL7 (C7R) Modified EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma
2 other identifiers
interventional
52
1 country
2
Brief Summary
This study is for patients that have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease which has come back or has not gone away after treatment, including the best treatment the investigators know for these diseases. Some patients with Lymphoma or T/NK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever ("mono") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma, suggesting that plays a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. T cells have been used to treat patients with cancers. T cells, that have been trained to kill EBV infected cells can survive in the blood and affect the tumor. The investigators have treated over 80 people on studies using T cells to target these diseases. About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses. The investigators think that if T cells are able to last longer in the body, they may have a better chance of killing EBV and EBV infected tumor cells. Therefore, in this study the investigators will add a new gene to the EBV T cells that can cause the cells to live longer called C7R. The investigators know that T cells need substances called cytokines to survive and the cells may not get enough cytokines after infusion into the body. The investigators have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time. The purpose of this study is to find the largest safe dose of C7R-EBV T cells, and additionally to evaluate how long they can be detected in the blood and what affect they have on cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2022
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2020
CompletedFirst Posted
Study publicly available on registry
December 11, 2020
CompletedStudy Start
First participant enrolled
October 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2039
ExpectedDecember 12, 2025
November 1, 2025
3.4 years
December 7, 2020
December 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1. Dose limiting toxicity rate (DLT) by Common Terminology Criteria for Adverse Events v5.0
Dose-limiting toxicity is defined as any irreversible, life threatening or non-hematologic Grade 3-5 event considered to be primarily related to the EBVST infusion, with the exception of Grade 3-4 expected reactions such as fever and hypotension/ Grade 3-4 CRS toxicity persistent beyond 72 hours.
28 days post infusion
Secondary Outcomes (1)
1. Response rate by Lymphoma Response to Immunomodulatory Therapy (LYRIC) criteria
6 weeks (±2 weeks) post infusion
Study Arms (2)
Arm A: Treatment without lymphodepletion chemotherapy
EXPERIMENTALC7R-EBVSTs Group B will be activated if only limited expansion and clinical efficacy is observed in Group A
Arm B: Treatment with lymphodepletion chemotherapy
EXPERIMENTALC7R-EBVSTs with lymphodepletion chemotherapy
Interventions
2 x 10\^7 cells/m2
6 x 10\^7 cells/m2
6 x 10\^7 cells/m2
2 x 10\^8 cells/m2
2 x 10\^8 cells/m2
Eligibility Criteria
You may qualify if:
- Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non Hodgkin's Lymphoma, (regardless of the histological subtype) or EBV (associated)- T/NK-lymphoproliferative disease who may subsequently be eligible for the treatment component
- EBV positive tumor (can be pending)
- Weighs at least 10 kg
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given a copy of informed consent.
- \) Any patient regardless of age or sex, with diagnosis of either
- EBV positive Hodgkin's lymphoma
- EBV positive non-Hodgkin's Lymphoma (regardless of histologic subtype)
- EBV (associated)-T/NK-lymphoproliferative disease
- AND either
- A) In first or subsequent relapse or with persistent active disease despite therapy; OR
- B) With active disease if immunosuppressive chemotherapy is contraindicated as determined by the study PI, in consultation with the primary provider as needed, e.g. patients who develop Hodgkin's disease after solid organ transplantation or if the lymphoma is a second malignancy, e.g. a Richter's transformation of CLL.
- \) EBV positive tumor confirmed by pathology
- \) Patients with life expectancy ≥ 6 weeks
- \) Patients with bilirubin ≤ 3x upper limit of normal, AST ≤ 3x upper limit of normal, creatinine ≤ 2x upper limit of normal for age and Hgb ≥ 7.0 (may be a transfused value)
- \) Pulse oximetry of \>90% on room air
- +3 more criteria
You may not qualify if:
- \. Known pregnancy or actively breastfeeding (pregnancy test is not required at the time of procurement).
- Pregnant or breastfeeding
- Active and uncontrolled bacterial, viral or fungal infection
- Current use of systemic corticosteroids (prednisone equivalent \>0.5 mg/kg/day)
- Bulky disease resulting in airway obstruction or risk for airway obstruction with further enlargement.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baylor College of Medicinelead
- The Methodist Hospital Research Institutecollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Houston Methodist Hospital
Houston, Texas, 77030, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Related Publications (2)
Sharma S, Mehta NU, Sauer T, Rollins LA, Dittmer DP, Rooney CM. Cotargeting EBV lytic as well as latent cycle antigens increases T-cell potency against lymphoma. Blood Adv. 2024 Jul 9;8(13):3360-3371. doi: 10.1182/bloodadvances.2023012183.
PMID: 38640255DERIVEDSharma S, Sauer T, Omer BA, Shum T, Rollins LA, Rooney CM. Constitutive Interleukin-7 Cytokine Signaling Enhances the Persistence of Epstein-Barr Virus-Specific T-Cells. Int J Mol Sci. 2023 Oct 31;24(21):15806. doi: 10.3390/ijms242115806.
PMID: 37958791DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bilal Omer, MD
Baylor College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 7, 2020
First Posted
December 11, 2020
Study Start
October 31, 2022
Primary Completion
April 1, 2026
Study Completion (Estimated)
March 30, 2039
Last Updated
December 12, 2025
Record last verified: 2025-11