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

UWELL Biopharma

Status and phase: Unknown; Phase 1

Conditions: B-cell Non-Hodgkin Lymphoma

Treatments: Genetic: Welgenaleucel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04296461

UBP-PCL-P01-3002-01

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Welgenaleucel (UWC19)

Experimental group

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.

Treatment:

Genetic: Welgenaleucel