Status:
ACTIVE_NOT_RECRUITING
Most Closely Matched 3rd Party Rapidly Generated LMP, BARF1 And EBNA1 Specific CTL, EBV-Positive Lymphoma (MABEL)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital Research Institute
Conditions:
Hodgkin Disease
Non-Hodgkin Lymphoma
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
The subject has a type of cancer or lymph gland disease associated with a virus called Epstein Barr Virus (EBV), which has come back, is at risk of coming back, or has not gone away after standard tre...
Detailed Description
A healthy donor has given blood to make LMP/BARF1/EBNA-1 MABEL CTLs in the lab. We made the cells by first growing a special type of cells called activated T cells to stimulate the T cells. We then ad...
Eligibility Criteria
Inclusion
- SCREENING
- 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
- Severe Chronic Active EBV (CAEBV) -- CAEBV is defined as patients with high EBV viral load in plasma or PBMC (\>4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV
- Other EBV positive malignancies (e.g. nasopharyngeal carcinoma, smooth muscle tumors, etc.)
- AND
- in first or subsequent relapse (Group A)
- with active disease persisting despite therapy (Group B)
- with active disease if immunosuppressive chemotherapy is contraindicated e.g. patients who develop Hodgkin disease after solid organ transplantation or if the lymphoma is a second malignancy e.g. a Richter's transformation of CLL. (Group C)
- EBV positive tumor
- Weighs at least 12kg
- Informed consent (and assent as applicable) obtained from patient/guardian.
- TREATMENT
- 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
- Severe Chronic Active EBV (CAEBV) -- CAEBV is defined as patients with high EBV viral load in plasma or PBMC (\>4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV
- Other EBV positive malignancies (e.g. nasopharyngeal carcinoma, smooth muscle tumors, etc.)
- AND
- in first or subsequent relapse (Group A)
- with active disease persist despite therapy (Group B)
- with active disease if immunosuppressive chemotherapy is contraindicated e.g. patients who develop Hodgkin disease after solid organ transplantation or if the lymphoma is a second malignancy e.g. a Richter's transformation of CLL. (Group C)
- EBV positive tumor
- Patients with life expectancy greater than or equal to 6 weeks
- Patients with bilirubin less than or equal to 3x upper limit of normal
- AST less than or equal to 5x upper limit of normal
- Hemoglobin greater than or equal to 7.0 (may be a transfused value)
- Patients with a creatinine less than or equal to 2x upper limit of normal for age
- Pulse oximetry of \> 90% on room air
- Patients should have been off other investigational therapy for 30 days prior to infusion.
- Patients with a Karnofsky/Lansky score of more than or equal to 50.
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
- Informed consent (and assent as applicable) obtained from patient/guardian.
Exclusion
- TREATMENT
- Pregnant or lactating
- Severe intercurrent infection
- Current use of systemic corticosteroids more than 0.5 mg/kg/day
- Patients receiving ATG, Campath, or other immunosuppressive T cell monoclonal antibodies within 30 days.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2029
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT02287311
Start Date
February 1 2015
End Date
March 1 2029
Last Update
February 24 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