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The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage: 100mL in total Frequency:the first day, the second day, the third day Duration:total three times

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

Welgenaleucel

Cheng-Yi Kuo, PhD

B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). Current treatments for B cell malignancies include chemotherapy, radiation therapy, bone marrow transplantation, and peripheral blood stem cell transplantation. Despite these treatment modalities, most patients will remain incurable. Welgenaleucel (UWC19) is a CD19-directed genetically-modified autologous immunotherapy. This study is designed to evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies, including DLBCL and ALL.

Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma

The type, frequency, severity, and duration of adverse events will be summarized

Liaocheng People's Hospital

UWELL Biopharma

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

B-cell Lymphoma

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.

Ching-Liang Ho, MD

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).

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.

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

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

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma	NCT03811457	Lymphoma Leukem...	Welgenaleucel	- 70 Years	UWELL Biopharma
Study of Welgenaleucel (UWC19) in Patients With Relapsed or Refractory B-cell Lymphoma	NCT04296461	B-cell Non-Hodg...	Welgenaleucel	20 Years - 70 Years	UWELL Biopharma
Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma	NCT03811457	Lymphoma Leukem...	Welgenaleucel	- 70 Years	UWELL Biopharma

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