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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04296461
Other study ID # UBP-PCL-P01-3002-01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 27, 2020
Est. completion date December 31, 2021

Study information

Verified date March 2020
Source UWELL Biopharma
Contact Cheng-Yi Kuo, PhD
Phone +886-2-26972200
Email jerry.kuo@uwell.com.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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

Study Design


Intervention

Genetic:
Welgenaleucel
Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.

Locations

Country Name City State
Taiwan Tri-Service General Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
UWELL Biopharma Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) 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. 30 days after infusion
Primary Dose Limiting Toxicities (DLT) 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. 30 days after infusion
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