Most Closely Matched 3rd Party Rapidly Generated LMP, BARF1 And EBNA1 Specific CTL, EBV-Positive Lymphoma (MABEL)

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

January 12, 2024

Study Completion Date

March 31, 2029

Conditions
Hodgkin DiseaseNon-Hodgkin LymphomaSevere Chronic Active Epstein Barr VirusT/NK-lymphoproliferative DiseaseNasopharyngeal CarcinomaSmooth Muscle Tumor
Interventions
BIOLOGICAL

MABEL CTLs

"Dose escalation:~DL1:2x10\^7 cells/m2+2x10\^7 cells/m2~DL2:2x10\^7cells/m2+5x10\^7 cells/m2~DL3:5x10\^7 cells/m2+1x10\^8 cells/m2~\*Doses are based on total CD3+cells/m2~Patients with active disease that have apparent clinical benefit at the 8 wk post 1st infusion (6 wks after 2nd infusion) or subsequent evaluations may receive up to 6 additional doses of CTLs at intervals at least 6 wks apart, each of which will consist of the same cell number as their second injection or below the original dose if there is not enough product available for the original dose. Patients may receive lymphodepleting chemotherapy (Cy/Flu) before additional infusions. Patients cannot receive additional doses until the initial safety profile is completed at 6 wks following the second infusion."

DRUG

Cyclophosphamide

"If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs.~3 daily doses of cyclophosphamide (Cy: 500 mg/m2/day) together with fludarabine (Flu: 30 mg/m2) to induce lymphopenia, finishing at least 24 hours before CTL infusion."

DRUG

Fludarabine

"If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide and fludarabine before s/he receives MABEL CTLs.~3 daily doses of cyclophosphamide (Cy: 500 mg/m2/day) together with fludarabine (Flu: 30 mg/m2) to induce lymphopenia, finishing at least 24 hours before CTL infusion."

Trial Locations (2)

77030

Houston Methodist Hospital, Houston

Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

collaborator

The Methodist Hospital Research Institute

OTHER

lead

Baylor College of Medicine

OTHER