Status:
RECRUITING
EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
National Cancer Institute (NCI)
Conditions:
EBV-Related Hodgkin Lymphoma
EBV-Related Lymphoproliferative Disorder
Eligibility:
All Genders
Phase:
PHASE1
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, ...
Detailed Description
The patient will donate blood in order to make C7R-EBV T cells. Depending on how long ago the cells were generated, they have been frozen. To get the C7R to be made by the T-cell, the investigators in...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA AT TIME OF PROCUREMENT
- 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.
- INCLUSION CRITERIA AT TIME OF INFUSION
- 1\) 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.
- 2\) EBV positive tumor confirmed by pathology
- 3\) Patients with life expectancy ≥ 6 weeks
- 4\) 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)
- 5\) Pulse oximetry of \>90% on room air
- 6\) Patients should have been off other investigational therapy for 4 weeks prior to entry in this study.
- 7\) Patients with a Karnofsky/Lansky score of ≥ 50
- 8\) Informed consent explained to, understood and signed by patient/guardian. Patient/guardian given a copy of informed consent.
- EXCLUSION CRITERIA AT TIME OF PROCUREMENT
- 1\. Known pregnancy or actively breastfeeding (pregnancy test is not required at the time of procurement).
- EXCLUSION CRITERIA AT TIME OF INFUSION
- 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.
Exclusion
Key Trial Info
Start Date :
October 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2039
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04664179
Start Date
October 31 2022
End Date
March 30 2039
Last Update
December 12 2025
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030