Clinical trial · Interventional
Genetically Engineered Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or Indolent B-Cell Non-Hodgkin Lymphoma
A Pilot Study to Evaluate the Safety and Feasibility of Cellular Immunotherapy Using Genetically Modified Autologous CD20-Specific T Cells For Patients With Relapsed or Refractory Mantle Cell and Indolent B Cell Lymphomas
- 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)
This phase I trial is studying the side effects of giving genetically engineered lymphocytes together with cyclophosphamide and aldesleukin in treating patients with relapsed or refractory mantle cell lymphoma or indolent B-cell non-Hodgkin lymphoma. Placing a gene that has been created in the laboratory into white blood cells may make the body build an immune response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Aldesleukin may stimulate the white blood cells to kill lymphoma cells. Giving genetically engineered lymphocytes together with cyclophosphamide and aldesleukin may be an effective treatment for mantle cell lymphoma and B-cell non-Hodgkin lymphoma
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS | 0.90 |
| Recurrent Grade 1 Follicular Lymphoma | Grade 1 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Grade 2 Follicular Lymphoma | Grade 2 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Mantle Cell Lymphoma | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| bone marrow aspiration | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| enzyme-linked immunosorbent assay | Other | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| gene rearrangement analysis | Genetic | — | UNRESOLVED |
| genetically engineered lymphocyte therapy | Biological | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (autologous CD20 specific T-cells)
- description
- CHEMOTHERAPY: Patients receive cyclophosphamide IV over 60 minutes. IMMUNOTHERAPY: Beginning 2 days after completion of cyclophosphamide, patients receive autologous CD20-specific T-cells IV over 30 minutes. Treatment repeats every 2-5 days for 3 courses. MAINTENANCE THERAPY: Beginning 2 hours after the last T-cell infusion, patients receive low-dose aldesleukin subcutaneously twice daily for 14 days. Subjects who have achieved at least a partial remission lasting a minimum of 6 months may, on a case-by-case basis, receive additional stored T cells following relapse.
- interventionNames
- Biological: therapeutic autologous lymphocytes
- Drug: cyclophosphamide
- Biological: aldesleukin
- Genetic: polymerase chain reaction
- Genetic: gene rearrangement analysis
- Procedure: lymph node biopsy
- Biological: genetically engineered lymphocyte therapy
- Procedure: bone marrow aspiration
- Other: flow cytometry
- Other: laboratory biomarker analysis
- Other: enzyme-linked immunosorbent assay
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Male or female subjects with immuno histopathologically documented CD20+ mantle cell lymphoma, follicular non-Hodgkin lymphoma (NHL), small lymphocytic lymphoma/chronic lymphocytic leukemia, marginal zone, or lymphoplasmacytic NHL of any age, gender, or ethnic group who have relapsed or are refractory to conventional chemotherapy and who are not eligible for Fred Hutchinson Cancer Research Center (FHCRC)/University of Washington Medical Center (UWMC) transplant protocols (or who refuse participation in transplant protocols) * Willingness to sign an informed consent and undergo study tests * Willingness to receive cytoreductive chemotherapy, if necessary to debulk tumors prior to T cell administration, and to receive cyclophosphamide for lymphodepletion * Serologic evidence of prior exposure to Epstein-Barr virus (EBV) * Meets safety criteria to undergo leukapheresis * Hemoglobin \> 9.0 gm/dL * White blood cell (WBC) \> 2500 per microliter * Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) =\< 2.5 x Upper Limit of Normal * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 x Upper Limit of Normal * Creatinine =\< 1.6 mg/dL * Willingness to use acceptable (barrier or hormonal methods) birth control as appropriate during the course of the study Exclusion Criteria: * Treatment with fludarabine or cladribine within the previous 2 years prior to apheresis * Known central nervous system involvement with NHL * Pulmonary involvement with NHL; a diagnosis of pulmonary lymphoma will be based in part on findings from chest computed tomography (CT) and, if clinically appropriate, lung biopsy * Exposure to chemotherapeutic agents (standard or experimental) or other immunosuppressive therapies less than four weeks prior to apheresis; patients must have recovered from acute side effects of such therapy * Positive serology for human immunodeficiency virus (HIV) * Active Hepatitis B or Hepatitis C infection * History of hypersensitivity reactions to murine proteins or seropositivity for human anti-mouse antibody (HAMA) * Requirement for corticosteroid therapy during the study period unless used specifically for amelioration of toxicity induced by transferred cells * Treatment with anti-CD20 antibodies (rituximab, tositumomab, ibritumomab) within 4 months prior to start of T cell infusions * Patients with lymph nodes in excess of 5 cm in diameter at time of T cell infusion * Patients with \> 5000 circulating CD20+ lymphocytes per mm\^3 at time of T cell infusion * Previous allogeneic stem cell transplantation * Life expectancy less than 90 days * Pregnancy
References
Publications (1)
- DERIVEDTill BG, Jensen MC, Wang J, Qian X, Gopal AK, Maloney DG, Lindgren CG, Lin Y, Pagel JM, Budde LE, Raubitschek A, Forman SJ, Greenberg PD, Riddell SR, Press OW. CD20-specific adoptive immunotherapy for lymphoma using a chimeric antigen receptor with both CD28 and 4-1BB domains: pilot clinical trial results. Blood. 2012 Apr 26;119(17):3940-50. doi: 10.1182/blood-2011-10-387969. Epub 2012 Feb 3. PMID 22308288