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

UWELL Biopharma1 site in 1 country20 target enrollmentJuly 27, 2020

ConditionsB-cell Non-Hodgkin Lymphoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: B-cell Non-Hodgkin Lymphoma
Sponsor: UWELL Biopharma
Enrollment: 20
Locations: 1
Primary Endpoint: Dose Limiting Toxicities (DLT)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

July 27, 2020

End Date

December 31, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

UWELL Biopharma

Responsible Party

Sponsor

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

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

Outcomes

Primary Outcomes

Dose Limiting Toxicities (DLT)

Time Frame: 30 days after infusion

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.

Maximum Tolerated Dose (MTD)

Time Frame: 30 days after infusion

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.