Clinical trial NCT04296461: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: B-cell Non-Hodgkin Lymphoma
Keywords: CD19
non-Hodgkin lymphoma
CAR-T cells
Lead sponsor: UWELL Biopharma
Sponsor class: INDUSTRY
Collaborators: name: Tri-Service General Hospital
First posted: 2020-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: 30 days after infusion
measure: Dose Limiting Toxicities (DLT)
timeFrame: 30 days after infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Tri-Service General Hospital
name: Ching-Liang Ho, MD
role: PRINCIPAL_INVESTIGATOR
References: