Imunace (teceleukin) / Shionogi - LARVOL DELTA

SAFETY AND FEASIBILITY OF GD2 IMMUNOTHERAPY IN NEUROBLASTOMA FOLLOWING AUTOLOGOUS VERSUS ALLOGENEIC TRANSPLANTATION: A RETROSPECTIVE STUDY (SIOP 2025) - "Background and Aims: GD2 immunotherapy for neuroblastoma, which combines granulocyte-colony stimulating factor (G-CSF) with recombinant interleukin-2 (IL-2, teceleukin), was introduced in Japan in September 2021... The completion rate of GD2 immunotherapy was lower after allo-HSCT than after auto-HSCT for neuroblastoma. However, discontinuation of allo-HSCT was primarily due to disease progression. Considering the observed safety profile, planned modifications are recommended to ensure safety when administering GD2 immunotherapy after allogeneic transplantation."

Retrospective data • Bone Marrow Transplantation • Hematological Disorders • Neuroblastoma • Neutropenia • Solid Tumor • Transplantation

NCI-2018-01509: Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P2 | N=16 | Terminated | Sponsor: M.D. Anderson Cancer Center | N=60 ➔ 16

Enrollment change • Carcinosarcoma • Colorectal Adenocarcinoma • Colorectal Cancer • Hepatology • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Refractory Ovarian Cancer • Sarcoma • Solid Tumor

NCI-2018-01509: Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P2 | N=60 | Terminated | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jan 2025 ➔ Aug 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2025 ➔ Aug 2024; Lack of Efficacy

Trial completion date • Trial primary completion date • Trial termination • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Refractory Ovarian Cancer • Sarcoma • Solid Tumor • CD27 • CD28 • CD8

Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: University of Kansas Medical Center | Trial primary completion date: Nov 2024 ➔ Nov 2025

Metastases • Trial primary completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

NCI-2018-01509: Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | N=27 ➔ 60 | Trial primary completion date: Jan 2024 ➔ Jan 2025

Enrollment change • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Refractory Ovarian Cancer • Sarcoma • Solid Tumor • CD27 • CD28 • CD8

Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: University of Kansas Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: University of Kansas Medical Center

New P2 trial • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2 | N=89 | Terminated | Sponsor: Washington University School of Medicine | Trial completion date: Dec 2024 ➔ Apr 2022 | Active, not recruiting ➔ Terminated; Insufficient funding/staff

Trial completion date • Trial termination • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2 | N=91 | Active, not recruiting | Sponsor: Washington University School of Medicine | Recruiting ➔ Active, not recruiting | N=140 ➔ 91 | Trial completion date: Sep 2029 ➔ Dec 2024 | Trial primary completion date: Sep 2024 ➔ Dec 2021

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2 | N=140 | Recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Sep 2028 ➔ Sep 2029 | Trial primary completion date: Sep 2023 ➔ Sep 2024

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P2; N=27; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Sep 2021 ➔ Jan 2025; Trial primary completion date: Sep 2021 ➔ Jan 2024

Clinical • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Refractory Ovarian Cancer • Sarcoma • Solid Tumor

Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P2; N=27; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Recruiting ➔ Active, not recruiting; N=60 ➔ 27

Clinical • Enrollment change • Enrollment closed • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor

Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Jonsson Comprehensive Cancer Center; Suspended ➔ Recruiting

Clinical • Enrollment open • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF • CD123 • IL2

Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2; N=140; Recruiting; Sponsor: Washington University School of Medicine; N=70 ➔ 140; Trial completion date: Dec 2020 ➔ Sep 2028; Trial primary completion date: Dec 2020 ➔ Sep 2023

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Early Administration of Low-Dose IL-2 Intensify Graft-Versus-Leukemia Effect without Worsening Gvhd through Sequential Enhancement of Effector T Cell and CD62L+ Regulatory T Cell Subset (ASH 2017) - "...Lethally irradiated B6D2F1 recipients were transplanted spleen cells and BM cells from B6 donors and 5000 IU Teceleukin (recombinant IL-2) was injected once a day for 14 days...In conclusion, our data indicate multiple effects of IL-2 on post-transplant immunity can coordinate to intensify GVL separately from GVHD on the mechanism of sequential enhancement of effector T cell and CD62L+ Treg in the different phases. These data provide the important information for developing Treg-targeted therapy."

Biosimilar • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology

Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma (clinicaltrials.gov) - P1; N=24; Suspended; Sponsor: Jonsson Comprehensive Cancer Center; Recruiting ➔ Suspended

Clinical • Trial suspension • Hematological Disorders • Melanoma • Oncology • Solid Tumor • BRAF • CD123 • IL2

Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2; N=70; Recruiting; Sponsor: Washington University School of Medicine; N=133 ➔ 70

Clinical • Enrollment change

Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Jonsson Comprehensive Cancer Center; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CD123

A Phase I/IIa Study of Antidisialoganglioside Antibody Dinutuximab in Japanese Patients With Neuroblastoma. (PubMed, J Pediatr Hematol Oncol) - "Patients also received macrophage colony-stimulating factor (M-CSF) or granulocyte colony-stimulating factor (G-CSF) during cycles 1, 3, and 5 combined with interleukin-2 teceleukin during cycles 2 and 4. At the end of the study, survival was confirmed in 22 patients (9 in the M-CSF group and 13 in the G-CSF group). From these results, we concluded that this combination regimen is a feasible treatment for Japanese patients with neuroblastoma."

Clinical • Journal • P1/2 data • CSF1 • IL2

Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Jonsson Comprehensive Cancer Center

New P1 trial