Study of Welgenaleucel (UWC19) in Patients With Relapsed or Refractory B-cell Lymphoma

B-cell Non-Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04296461
• Other study ID #: UBP-PCL-P01-3002-01
• Status: Recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• B-cell Non-Hodgkin Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

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