Status:
UNKNOWN
Study of Welgenaleucel (UWC19) in Patients With Relapsed or Refractory B-cell Lymphoma
Lead Sponsor:
UWELL Biopharma
Collaborating Sponsors:
Tri-Service General Hospital
Conditions:
B-cell Non-Hodgkin Lymphoma
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
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 lympho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04296461
Start Date
July 27 2020
End Date
December 31 2021
Last Update
January 22 2021
Active Locations (1)
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1
Tri-Service General Hospital
Taipei, Taiwan, 11490