Clinical trial · Interventional
Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma
Phase I/II Study of Cellular Immunotherapy Using Central Memory-Enriched CD8+ T Cells Lentivirally Transduced to Express A CD19-Specific Chimeric Immunoreceptor Following Peripheral Blood Stem Cell Transplantation for Patients With High-Risk Intermediate Grade B-Lineage Non-Hodgkin Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
This phase I/II trial studies the side effects and best dose of genetically engineered lymphocyte therapy and to see how well it works after peripheral blood stem cell transplant (PBSCT) in treating patients with high-risk, intermediate-grade, B-cell non-Hodgkin lymphoma (NHL). Genetically engineered lymphocyte therapy may stimulate the immune system in different ways and stop cancer cells from growing. Giving rituximab together with chemotherapy before a PBSCT stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim (G-CSF), or plerixafor helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving genetically engineered lymphocyte therapy after PBSCT may be an effective treatment for NHL.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 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 Grade 3 Follicular Lymphoma | Grade 3 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Mantle Cell Lymphoma | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Filgrastim | Biological | Filgrastim | ALIAS |
| Genetically Engineered Lymphocyte Therapy | Biological | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Peripheral Blood Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Plerixafor | Drug | Plerixafor | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cellular adoptive immunotherapy following PBSCT)
- description
- Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with G-CSF and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplant. Patients receive standard myeloablative conditioning followed by autologous PBSCT. Patients then undergo infusion of ex vivo expanded autologous TCM-enriched CD8+ T cells expressing CD19-specific CAR on day 2 or 3 after transplant.
- interventionNames
- Procedure: Autologous Hematopoietic Stem Cell Transplantation
- Biological: Filgrastim
- Biological: Genetically Engineered Lymphocyte Therapy
- Other: Laboratory Biomarker Analysis
- Procedure: Peripheral Blood Stem Cell Transplantation
- Drug: Plerixafor
- Biological: Rituximab
Primary outcomes (3)
- measure
- Number of Participants With Dose Limiting Toxicities (DLTs)
- timeFrame
- Within 28 days of T-cell infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * City of Hope (COH) pathology review confirms that research participant's diagnostic material is consistent with history of intermediate grade B-cell NHL (e.g., diffuse B-cell lymphoma, mantle cell lymphoma, transformed follicular lymphoma) * History of relapse after achieving first remission with primary therapy, or failure to achieve remission with primary therapy * Life expectancy \> 16 weeks * Karnofsky performance scale (KPS) \>= 70% * Negative serum pregnancy test for women of childbearing potential * Research participant has an indication to be considered for autologous stem cell transplantation Exclusion Criteria: * Fails to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I/II study; evidence of understanding includes passing the Protocol Comprehensive Screening given by the Research Subject Advocate (RSA); a legal guardian may substitute for the research participant * Any standard contraindications to myeloablative HSCT per standard of care practices at COH * Dependence on corticosteroids * Currently enrolled in another investigational therapy protocol * Human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of enrollment * History of allogeneic HSCT or prior autologous HSCT * Active autoimmune disease requiring systemic immunosuppressive therapy * Research participant(s) who are to receive radioimmunotherapy (Zevalin-based)-based conditioning regimens * Research participant(s) with known active hepatitis B or C infection
References
Publications (2)
- DERIVEDErnst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. PMID 34515338
- DERIVEDWang X, Popplewell LL, Wagner JR, Naranjo A, Blanchard MS, Mott MR, Norris AP, Wong CW, Urak RZ, Chang WC, Khaled SK, Siddiqi T, Budde LE, Xu J, Chang B, Gidwaney N, Thomas SH, Cooper LJ, Riddell SR, Brown CE, Jensen MC, Forman SJ. Phase 1 studies of central memory-derived CD19 CAR T-cell therapy following autologous HSCT in patients with B-cell NHL. Blood. 2016 Jun 16;127(24):2980-90. doi: 10.1182/blood-2015-12-686725. Epub 2016 Apr 26. PMID 27118452