Clinical trial · Interventional
Study of Welgenaleucel (UWC19) in Patients With Relapsed or Refractory B-cell Lymphoma
Phase 1 Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of Welgenaleucel (UWC19) in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
NCT04296461CI-TRIAL-00049570unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 is an open-label, single-center Phase 1/2 study with a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2) in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL).
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 |
|---|---|---|---|
| B-cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Welgenaleucel | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Welgenaleucel (UWC19)
- description
- Part I The safety and efficacy of Welgenaleucel (UWC19) will be evaluated in a standard 3+3 dose escalation approach.The planned dose escalation cohort levels for Welgenaleucel (UWC19) are 4, 8, 12, 16 and 20 x10\^6 CAR-T cells/kg administered intravenously once.
- interventionNames
- Genetic: Welgenaleucel
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- 30 days after infusion
- description
- A standard 3+3 trial design will be used for Welgenaleucel (UWC19) dose escalation cohorts.The dosing of Welgenaleucel (UWC19) will be divided into 5 cohorts, the subjects will receive Welgenaleucel (UWC19) once on day 14-18 after apheresis.
- measure
- Dose Limiting Toxicities (DLT)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: Have a primary diagnosis of B cell non-Hodgkin lymphoma \- Histologically confirmed: Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B Cell Lymphoma (PMBCL), Transformation Follicular Lymphoma (TFL), High grade B-cell Lymphoma (HGBCL), Mantle cell Lymphoma (MANT), Burkitt Lymphoma (BURK), Lymphoblastic Lymphoma * Chemotherapy-refractory disease, defined as one of more of the following No response to last line of therapy OR Refractory post-autologous stem cell transplant (ASCT) * Individuals must have received adequate prior therapy including at a minimum: anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative and an anthracycline containing chemotherapy regimen for individual with transformed FL must have chemorefractory disease after transformation to DLBCL. * No active infection of HIV, HTLV and Syphilis * Adequate renal function * Adequate hepatic function * Adequate cardiac function * Adequate venous access for apheresis, and no other contraindications for leukapheresis * Voluntary informed consent is given. Exclusion Criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: * Received allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) * Body weight less than 30 kg * Pregnant or lactating women. * Uncontrolled active infection. * History of hepatitis B or hepatitis C infection. * Previously treatment with any gene therapy products or cell therapy product in past 28 days. * HIV infection. * Lymphoma with central nervous system (CNS) involvement * Have autoimmune disorders * Have active infection or inflammatory disorders * Prescreening test results in expansion rate less than 5 folds * An allergy to gentamycin and/or streptomycin
References
Publications (0)
Data not yet available
No reference posted for this study.