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

Primary Purpose

B-cell Non-Hodgkin Lymphoma

Status

Unknown status

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

Welgenaleucel

About this trial

This is an interventional treatment trial for B-cell Non-Hodgkin Lymphoma focused on measuring CD19, non-Hodgkin lymphoma, CAR-T cells

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tri-Service General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Welgenaleucel (UWC19)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04296461

First Posted

March 2, 2020

Last Updated

January 16, 2021

Sponsor

UWELL Biopharma

Collaborators

Tri-Service General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04296461

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 27, 2020 (Actual)

Primary Completion Date

June 30, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UWELL Biopharma

Collaborators

Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

B-cell Non-Hodgkin Lymphoma

Keywords

CD19, non-Hodgkin lymphoma, CAR-T cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Welgenaleucel (UWC19)

Arm Type

Experimental

Arm Description

Intervention Type

Genetic

Intervention Name(s)

Welgenaleucel

Other Intervention Name(s)

UWC19

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose (MTD)

Description

Time Frame

30 days after infusion

Title

Dose Limiting Toxicities (DLT)

Description

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.

Time Frame

30 days after infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cheng-Yi Kuo, PhD

Phone

+886-2-26972200

Ext

202

jerry.kuo@uwell.com.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ching-Liang Ho, MD

Organizational Affiliation

Tri-Service General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tri-Service General Hospital

City

Taipei

ZIP/Postal Code

11490

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ching-Liang Ho, MD

12. IPD Sharing Statement

Learn more about this trial

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

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