Clinical Trials /

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

NCT04296461

Description:

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).

Related Conditions:
  • Burkitt Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Lymphoblastic Lymphoma
  • Mantle Cell Lymphoma
  • Primary Mediastinal B-Cell Lymphoma
  • Transformed Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04296461

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: UBP-PCL-P01-3002-01
  • NCT ID: NCT04296461

Conditions

  • B-cell Non-Hodgkin Lymphoma

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Welgenaleucel (UWC19)ExperimentalPart 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.

    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
    Maximum Eligible Age:70 Years
    Minimum Eligible Age:20 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Maximum Tolerated Dose (MTD)
    Time Frame:30 days after infusion
    Safety Issue:
    Description: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.

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:UWELL Biopharma

    Trial Keywords

    • CD19
    • non-Hodgkin lymphoma
    • CAR-T cells

    Last Updated

    January 22, 2021