Immune Consolidation With Allogeneic Activated T Cells Armed With OKT3 x Rituxan (Anti-CD3 x Anti-CD20) Bispecific Antibody (CD20Bi) After Allogeneic Peripheral Blood Stem Cell Transplant for High Risk CD20+ Non-Hodgkin's Lymphoma (Phase I)
- Determine the maximum tolerated dose of donor-derived allogeneic anti-CD3 X anti-CD20
bispecific antibody (CD20Bi)-armed activated T cells (ATC) when given with low-dose
aldesleukin and low-dose sargramostim (GM-CSF) after allogeneic stem cell
transplantation in patients with relapsed or refractory CD20-positive non-Hodgkin
- Perform trafficking studies using indium I 111-labeled unarmed ATC and ATC armed with
CD20Bi in patients with evaluable lymphoma sites to determine whether armed ATC
specifically traffic to tumor sites and correlate these data with CT and PET scans.
- Evaluate immune responses and immune reconstitution of T and B cells.
OUTLINE: All patients receive high-dose chemotherapy that is standard of care for their
disease. Peripheral blood lymphocytes are obtained from the HLA-identical sibling donor and
cultured to obtain activated T cells (ATC), some of which are subsequently armed with CD20
bispecific antibody (CD20Bi) and cryopreserved for later use. Patients then undergo
allogeneic hematopoietic stem cell transplantation (SCT).
Patients receive ATC-CD20Bi IV on days 40, 70, 100, 130, and 160 after SCT. Patients receive
low-dose aldesleukin subcutaneously (SC) once daily for 7 days beginning within 24 hours
after each ATC-CD20Bi infusion and low-dose sargramostim (GM-CSF) SC every other day for 3
doses beginning within 24 hours after each infusion of ATC-CD20Bi. Patients also receive
tacrolimus and mycophenolate mofetil as standard graft-vs-host disease prophylaxis.
Treatment continues in the absence of unacceptable toxicity.
Some patients with well-defined or evaluable masses receive indium I 111 (^111I)-labeled
ATC-CD20Bi IV and ^111I-labeled unarmed ATC and then undergo whole-body imaging for
After completion of study treatment, patients are followed at 6 months, 12 months, and then
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
Lawrence G. Lum, MD, DSc
Barbara Ann Karmanos Cancer Institute
United States: Food and Drug Administration