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

Phase 1

• Conditions: B-cell Non-Hodgkin Lymphoma
• Interventions: Genetic: Welgenaleucel

• Registration Number: NCT04296461
• Lead Sponsor: UWELL Biopharma

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-05
• Study Start: 2020-07-27
• Last Update Submitted: 2021-01-16
• Last Update Posted: 2021-01-22
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Welgenaleucel (UWC19)	Welgenaleucel	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.

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities (DLT)	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)	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.

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan