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Immunomodulating Agents

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

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Antineoplastic Agents

Antirheumatic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Determine the maximum tolerated dose (MTD) of CAR19-tTreg. It will be administered in a single dose after high dose lymphodepleting chemotherapy to promote adoptive transfer. First dose of 1.0 x 10 6 CAR19-tTreg/kg recipient body weight (dose level 1).The subsequent doses are 3.0, 10.0 and 30.0 x 10 6 CAR19- tTreg/kg. PHASE II Expand trial on maximum tolerated dose (MTD) of CAR19-tTreg from Phase I. It will be administered in a single dose after high dose lymphodepleting chemotherapy to promote adoptive transfer.The CAR19-tTreg/kg dose is to be determined.

A single dose administration of CAR19-tTreg

allogeneic CAR19 regulatory T cells (CAR19-tTreg)

Fludarabine 30 mg/m\^2 is administered as an intravenous (IV) infusion per institutional guidelines once a day on 4 consecutive days (Day -5, Day -4, Day -3 and Day -2)

Cyclophosphamide 500 mg/m\^2 is administered as an IV infusion per institutional guidelines once a day on 2 consecutive days (Day -5, and Day -4)

Cancer Center Clinical Trials Office

Veronika Bachanova, MD

Bachanova Veronika, MD

This is a single-center, single-arm, interventional phase I/II trial to evaluate the safety profile and potential efficacy of allogeneic CAR19 regulatory T cells (CAR19-tTreg) in adults with relapsed/refractory (R/R) CD19+ B Acute Lymphocytic Leukemia (B-ALL).

The study consists of two components. The dose finding component is a modified version of a Phase I trial and the extended component is a modified Phase II trial.

Evaluate the safety profile and potential efficacy of allogeneic CAR19 regulatory T cells (CAR19-tTreg)

Ph I/II Study of CAR19 Regulatory T Cells (CAR19-tTreg) for R/R CD19+ B-ALL

Phase I/II First-in-Human Trial With CAR19 Regulatory T Cells (CAR19-tTreg) in Adults With Relapsed/Refractory CD19+ B Acute Lymphocytic Leukemia

To identify the MTD of CAR19-tTregs defined asthe dose level that most closely corresponds to a dose limiting toxicity rate(DLT) less than or equal to 25%. Using grade 3-5 Common Terminology Criteria for Adverse Events version 5 (CTCAEv5) Statistical Analysis: The proportion of patients with ORR, CR and adverse events by day 28 will be estimated by simple proportions with 95% confidence intervals

Efficacy estimate as measured by overall response rate

Report number patients that achieved complete response (CR)

Evaluated using the American Society of Transplantation and Cellular Therapy (ASTCT) CRS consensus grading system

Report the count of neurotoxicities based on the ICANS system.

Report the count of relapses out of those that achieved complete reponse

Report the count (as proportions) of relapses out of those that achieved complete re

The analysis of overall survival will use death as the event, and the analysis of event-free survival will use the earliest of no response, relapse, or death as the event. Patients who do not have an event will have their data censored for the analyses at the date at which they were last known to be alive. Finally, probabilities will be measured using Kaplan-Meier curves

Masonic Cancer Center, University of Minnesota

Carcinoma

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

This group of patients will receive Intravenous Doxil of 50mgm/m2 over 15 minutes and plasma concentration will be measured at time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days

This group of patients will receive Intravenous Doxorubicin of 50mgm/m2 over 15 minutes and plasma concentration will be measured at time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days

To measure bioavailabity of Doxil versus Doxorubicin

Ajai Prakash

Doxil or Doxorubicin to be administered was administered in a dose of 50 mg/m2 as infusion over 15 minutes. Blood samples to be obtained at 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours

Comparison of AUC in a single dose of Doxorubicin vs single dose of Doxil \[ Time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days) The primary objective of this study is to determine the pharmacokinetic equivalence of Doxorubicin and Doxil as a single dose in patients with carcinomas, lymphomas and leukemia's. The outcome measure will be determined by analyzing the concentration from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (C max)to determine % variability between doxorubicin and Doxil within each patient.

A Phase 1, single-blind, randomized, two-way, crossover Bio-equivalence study of Intravenously administered Doxorubicin in Patients With lymphomas, leukemia's and carcinoma That Has Progressed or Recurred After Platinum-based Chemotherapy

To Study the Concentration Level of, Doxil, and Doxorubicin at Various Time Frames

A Bio Equivalence Study of DOXIL and Doxorubicin in Subjects With Lymphoma, Leukemia and Carcinoma

Intravenous Doxil versus Doxorubicin of 50mgm/m2 over 15 minutes and plasma concentration will be measured at time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days.

Maximum observed plasma concentration of doxorubicin versus Doxil in participants at time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days.

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
Ph I/II Study of CAR19 Regulatory T Cells (CAR19-tTreg) for R/R CD19+ B-ALL	NCT05114837	Lymphoma Leukem...	allogeneic CAR1... Fludarabine Cyclophosphamid...	18 Years -	Masonic Cancer Center, University of Minnesota
Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma	NCT03811457	Lymphoma Leukem...	Welgenaleucel	- 70 Years	UWELL Biopharma
To Study the Concentration Level of, Doxil, and Doxorubicin at Various Time Frames	NCT03975205	Lymphoma Leukem...	Doxorubicin	18 Years - 75 Years	Sutphin Drugs

Spots Global Cancer Trial Database for lymphoma leukemia