B-cell Non-Hodgkin Lymphoma
Conditions
Keywords
CD19, non-Hodgkin lymphoma, CAR-T cells
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).
Interventions
GENETICWelgenaleucel
Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.
Sponsors
Tri-Service General Hospital
UWELL Biopharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Taiwan
Contacts
Primary ContactCheng-Yi Kuo, PhD
Outcome results
None listed