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

Sponsor
UWELL Biopharma (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04296461
Collaborator
Tri-Service General Hospital (Other)
20
1
1
17.1
1.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Genetic: Welgenaleucel
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A standard 3+3 trial design will be used Welgenaleucel(UWC19) dose escalation cohorts. The planned dose escalation cohort levels for Welgenaleucel (UWC19) are 4, 8, 12, 16 and 20 x10^6 CAR-T cells/kg.A standard 3+3 trial design will be used Welgenaleucel(UWC19) dose escalation cohorts. The planned dose escalation cohort levels for Welgenaleucel (UWC19) are 4, 8, 12, 16 and 20 x10^6 CAR-T cells/kg.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 27, 2020
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Genetic: Welgenaleucel
Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.
Other Names:
  • UWC19
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tri-Service General Hospital Taipei Taiwan 11490

    Sponsors and Collaborators

    • UWELL Biopharma
    • Tri-Service General Hospital

    Investigators

    • Principal Investigator: Ching-Liang Ho, MD, Tri-Service General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UWELL Biopharma
    ClinicalTrials.gov Identifier:
    NCT04296461
    Other Study ID Numbers:
    • UBP-PCL-P01-3002-01
    First Posted:
    Mar 5, 2020
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by UWELL Biopharma
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 22, 2021