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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)

Phase 1
18 Years
Not Enrolling

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Trial Information

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
trafficking studies.

After completion of study treatment, patients are followed at 6 months, 12 months, and then
annually thereafter.

Inclusion Criteria


- Histologically confirmed CD20-positive non-Hodgkin lymphoma

- Relapsed, resistant, or chemorefractory disease

- Must have an available HLA-identical sibling donor

- No significant skin breakdown from tumor or other disease


- ECOG performance status 0-2

- DLCO ≥ 50% of normal

- No symptomatic obstructive or restrictive pulmonary disease

- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min

- Direct bilirubin ≤ 2.0 mg/dL (even if attributable to disease)

- SGOT and SGPT ≤ 2.5 times normal (even if attributable to disease)

- No history of severe hepatic dysfunction

- No severe cardiac dysfunction

- LVEF ≥ 50% by gated blood pool scan

- No major heart disease

- Patients with congenital or acquired heart disease or cardiac arrhythmias must
undergo a cardiology consultation and evaluation

- No active infections

- Patients who have not been seen and evaluated by a dentist for teeth cleaning
and examination for potential sources of infection are ineligible

- HIV antibody negative

- No uncompensated major thyroid or adrenal dysfunction

- Not pregnant or nursing

- Persistently elevated systolic blood pressure (BP) ≥ 130 mm Hg or diastolic BP ≥ 80
mm Hg must be controlled with antihypertensive agents for at least 7 days prior to
initiation of cell therapy

- Patients with essential hypertension that is controlled with medication are


- Prior total dose of doxorubicin or daunorubicin must have been less than 450 mg/m^2
unless an endomyocardial biopsy shows less than grade 2 drug effect

- No concurrent nitroglycerin preparations for angina pectoris

- No antiarrhythmic drugs for major ventricular dysrhythmias

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Safety Issue:


Principal Investigator

Lawrence G. Lum, MD, DSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

October 2007

Completion Date:

July 2008

Related Keywords:

  • Lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • Waldenstrom macroglobulinemia
  • adult nasal type extranodal NK/T-cell lymphoma
  • recurrent adult grade III lymphomatoid granulomatosis
  • cutaneous B-cell non-Hodgkin lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin