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

NCT ID: NCT04296461

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-27
• Study Completion Date: 2021-12-31

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).

Conditions

B-cell Non-Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Welgenaleucel

Intervention Type: GENETIC

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

Interventions

Welgenaleucel

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

Intervention Type: GENETIC

Other Intervention Names

UWC19

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: collaborator

UWELL Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-Liang Ho, MD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

Tri-Service General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Cheng-Yi Kuo, PhD

Role: CONTACT

jerry.kuo@uwell.com.tw

+886-2-26972200 ext. 202

Facility Contacts

Ching-Liang Ho, MD

Role: primary

Other Identifiers

UBP-PCL-P01-3002-01

Identifier Type: -

Identifier Source: org_study_id