Antigen Targeted T Cell Therapy for Relapsed/Refractory B Cell Lymphomas
This is a single center, open label, phase 1 lead in to determine Recommended Phase 2 Dose (RP2D), followed by a phase 2 trial to evaluate the safety and efficacy of Epo-R-CD19 CAR T with or without CD22 CAR T-cells infused into patients with B cell lymphoma. The study will have the following parts: * Screening * Pre-i
| Condition(s) | B-cell Lymphoma Refractory |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This is a single center, open label, phase 1 lead in to determine Recommended Phase 2 Dose (RP2D), followed by a phase 2 trial to evaluate the safety and efficacy of Epo-R-CD19 CAR T with or without CD22 CAR T-cells infused into patients with B cell lymphoma. The study will have the following parts: * Screening * Pre-infusion (cell product preparation and bridging) and infusion (lymphodepletion) * Primary efficacy endpoints * Long term follow up Patients who have high risk B cell lymphoma or relapsed/refractory B cell lymphoma who fufil the trial inclusion and exclusion criteria will undergo leukapheresis following trial enrollment. CAR T-cell products will then be manufactured according to the antigen expression on the patient's biopsied tumor cells. These cells will then undergo stringen |
| Who can participate | Inclusion Criteria * Age 10 to 80 years at screening * PET-CT measurable disease by Lugano classification (Deauville score of ≥4) and * Tissue biopsy of any tumour site and flow cytometry study of CD19 and CD22 expression. * Relapsed B-cell lymphoma after one line of systemic therapy or autologous bone marrow transplant. This includes DLBCL, PMBCL, HGBCL, DLBCL arising from indolent lymphoma, Burkitt's lymphoma/leukemia, Mantle cell lymphoma. * High risk B-cell lymphoma (BCL). High risk BCL is defined by any of the criteria below: * High-risk genetics - double/triple hit or p53mut or deletion. * IPI score ≥ 3 * Richter's transformation from chronic lymphocytic leukaemia. * Disease refractory to treatment - PET-CT positive disease after 2 courses of rituximab-containing chemoimmunotherapy. |
| Ages | 10 Years to 80 Years |
| Sex | All |
| Lead sponsor | National University Hospital, Singapore |
| Locations | Singapore, Singapore, Singapore |
| Start date | 2026-03-02 |
| NCT ID | NCT07319676 |
| Official listing | https://clinicaltrials.gov/study/NCT07319676 |