NCT04296461

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 27, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 22, 2021

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

March 2, 2020

Last Update Submit

January 16, 2021

Conditions

B-cell Non-Hodgkin Lymphoma

Keywords

CD19non-Hodgkin lymphomaCAR-T cells

Outcome Measures

Primary Outcomes (2)

  • Maximum Tolerated Dose (MTD)

    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.

    30 days after infusion

  • Dose Limiting Toxicities (DLT)

    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.

    30 days after infusion

Study Arms (1)

Welgenaleucel (UWC19)

EXPERIMENTAL

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

Interventions

WelgenaleucelGENETIC

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

Also known as: UWC19
Welgenaleucel (UWC19)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-Service General Hospital

Taipei, 11490, Taiwan

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-CellLymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Ching-Liang Ho, MD

    Tri-Service General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-Yi Kuo, PhD

CONTACT

+886-2-26972200jerry.kuo@uwell.com.tw

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 5, 2020

Study Start

July 27, 2020

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

January 22, 2021

Record last verified: 2020-03

Locations

TW(1)