Clinical trial · Interventional
Donor T Cells, Low-Dose Aldesleukin, and Low-Dose GM-CSF After Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Giving high doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. Colony stimulating factors, such as aldesleukin and GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells that have been treated with antibodies after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of donor T cells given together with low-dose aldesleukin and low-dose GM-CSF after donor stem cell transplant in treating patients with relapsed or refractory non-Hodgkin's lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-CD3 x anti-CD20 bispecific antibody-armed activated T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Maximum tolerated dose
- measure
- Time to relapse
- measure
- Disease-free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * 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 eligible PRIOR CONCURRENT THERAPY: * 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
References
Publications (0)
Data not yet available