Study of Welgenaleucel (UWC19) in Patients With Relapsed or Refractory B-cell Lymphoma
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Welgenaleucel (UWC19) 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. |
Genetic: Welgenaleucel
Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Maximum Tolerated Dose (MTD) [30 days after infusion]
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.
- Dose Limiting Toxicities (DLT) [30 days after infusion]
The 3+3 design entails that if one patient out of the first three patients has a DLT, up to three additional patients will be entered at that dose level.
Eligibility Criteria
Criteria
Inclusion Criteria:
Have a primary diagnosis of B cell non-Hodgkin lymphoma
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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
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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)
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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.
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No active infection of HIV, HTLV and Syphilis
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Adequate renal function
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Adequate hepatic function
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Adequate cardiac function
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Adequate venous access for apheresis, and no other contraindications for leukapheresis
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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:
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Received allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
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Body weight less than 30 kg
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Pregnant or lactating women.
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Uncontrolled active infection.
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History of hepatitis B or hepatitis C infection.
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Previously treatment with any gene therapy products or cell therapy product in past 28 days.
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HIV infection.
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Lymphoma with central nervous system (CNS) involvement
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Have autoimmune disorders
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Have active infection or inflammatory disorders
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Prescreening test results in expansion rate less than 5 folds
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An allergy to gentamycin and/or streptomycin
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Tri-Service General Hospital | Taipei | Taiwan | 11490 |
Sponsors and Collaborators
- UWELL Biopharma
- Tri-Service General Hospital
Investigators
- Principal Investigator: Ching-Liang Ho, MD, Tri-Service General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UBP-PCL-P01-3002-01