Administration of TAA-Specific CTLs; Hodgkin or Non-Hodgkin Lymphoma; TACTAL

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

September 27, 2021

Study Completion Date

September 27, 2027

Conditions
Hodgkin LymphomaNon-Hodgkin LymphomaHodgkin Disease
Interventions
BIOLOGICAL

Antigen-Escalation Stage

"Antigen-Escalation Stage~Each patient will receive 2 injections at the same dose (5 x 10\^6 cells/m2), 28 days apart, according to the following schedules:~Schedule One:~* Day 0: PRAME-specific T cells~* Day 28: PRAME- and SSX-specific T cells~Schedule Two:~* Day 0: PRAME- and SSX-specific T cells~* Day 28: PRAME/SSX/MAGE-specific T cells~Schedule Three:~* Day 0: PRAME/SSX/MAGE-specific T cells~* Day 28: PRAME/SSX/MAGE/NY-ESO specific T cells~Schedule Four:~* Day 0: PRAME/SSX/MAGE/NY-ESO specific T cells~* Day 28: PRAME/SSX/MAGE/NY-ESO/Survivin-specific T cells"

BIOLOGICAL

Dose-Escalation Stage

"Dose-Escalation Stage~Three different dosing schedules will be evaluated. Each patient will receive 2 injections at the same dose, 14 days apart, according to the following dosing schedules:~DL1: Day 0 and Day 14: 5 x 10\^6 cells/m\^2~DL2: Day 0 and Day 14: 1 x 10\^7 cells/m\^2~DL3: Day 0 and Day 14: 2 x 10\^7 cells/m\^2"

BIOLOGICAL

azacytidine and multiTAA T cells Stage

"Up to 15 patients will be treated with 3 cycles of aza at a dose of 75 mg/m2 I.V. administered for 5 days/cycle followed, within 28 days of the last aza dose, by two infusions (on Day 0 and Day 14) of multi-TAA specific CTLs at a fixed dose of 1x10\^7 cells/m2. If drug-related myelosuppression occurs aza dosing will be modified, according to the following:~1. ANC \>1,000 or Platelets \>50,000 (or any other grade I AE attributable to aza)~ Adjustment: None~2. ANC 500-1000 or Platelets 25,000-50,000 (or any other grade II-III AE attributable to aza)~ Adjustment: 50% dose reduction~3. ANC \<500 or any episode of febrile neutropenia or platelets \<25,000 or any episode of bleeding attributed to thrombocytopenia (or any other grade IV or higher AE attributable to aza)~Adjustment: Discontinue drug, can proceed with CTL infusion if eligible within 28 days of last aza infusion"

BIOLOGICAL

Pediatric multiTAA T cells Stage

Patients \< 18 years old will receive two infusions (on Day 0 and Day 14) of multi-TAA specific T cells at a fixed dose of 1x10\^7 cells/m2. We will enroll and infuse at least 5 adolescents on the pediatric arm before opening to all patients.

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

collaborator

National Cancer Institute (NCI)

NIH

lead

Baylor College of Medicine

OTHER