human interleukin-2 inhalation / Immunservice - LARVOL DELTA

Safety and preliminary activity of hydroxychloroquine and aldesleukin in metastatic renal cell carcinoma (mRCC): A cytokine working group study. (ASCO-GU 2017) - P1/2; "Background: Aldesleukin (recombinant human interleukin-2) has been an FDA-approved treatment for mRCC since 1992, based on a 5-10% rate of durable complete remissions. HCQ in combination with aldesleukin was found to be tolerable at a dose of 600 mg daily, with expected toxicities. Clinical responses have been observed."

Renal Cell Carcinoma

Safety and activity of hydroxychloroquine and aldesleukin in metastatic renal cell carcinoma: A cytokine working group phase II study. (ASCO 2018) - P1/2; "NCT01550367 Background: Aldesleukin (recombinant human interleukin-2, IL-2) has been an FDA-approved treatment for mRCC since 1992 with a 5-10% rate of durable complete response. IL-2 plus HCQ was well tolerated and clinically active with encouraging PFS of 17 months at the 600 mg HCQ dose."

Clinical • P2 data • Renal Cell Carcinoma

Bispecific Antibody Armed Activated T-cells With Aldesleukin and Sargramostim in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1/2; N=43; Recruiting; Sponsor: Barbara Ann Karmanos Cancer Institute; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

Tumor-Infiltrating Lymphocytes After Combination Chemotherapy in Treating Patients With Metastatic Melanoma (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Fred Hutchinson Cancer Research Center; N=120 -> 40

Enrollment change • Biosimilar • Melanoma • Oncology

Genetically Modified T Cells in Treating Patients With Stage III-IV Non-small Cell Lung Cancer or Mesothelioma (clinicaltrials.gov) - P1/2; N=20; Recruiting; Sponsor: Fred Hutchinson Cancer Research Center; Trial primary completion date: Dec 2016 ➔ Jun 2017

Trial primary completion date • Biosimilar • Mesothelioma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology

Viral Oncoprotein Targeted Autologous T Cell Therapy for Merkel Cell Carcinoma (clinicaltrials.gov) - P1/2; N=4; Active, not recruiting; Sponsor: Fred Hutchinson Cancer Research Center; Recruiting ➔ Active, not recruiting; N=16 ➔ 4

Enrollment change • Enrollment closed • Biosimilar • Dyslipidemia • Oncology • Small Cell Lung Cancer

Aldesleukin With or Without Ziv-Aflibercept in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery (clinicaltrials.gov) - P2; N=105; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Dec 2016 ➔ Dec 2017

Trial primary completion date • Biosimilar • Melanoma • Oncology • Reperfusion Injury

Aldesleukin and Pembrolizumab in Treating Patients With Stage III-IV Melanoma (clinicaltrials.gov) - P2; N=65; Not yet recruiting; Sponsor: Rutgers, The State University of New Jersey; Initiation date: Jan 2017 ➔ Sep 2017

Trial initiation date • Biosimilar • Melanoma • Oncology

Phase 1 clinical trial of adoptive immunotherapy using "off-the-shelf" activated natural killer cells in patients with refractory and relapsed acute myeloid leukemia. (PubMed, Cytotherapy) - "The trial demonstrated the safety and feasibility of adoptive cell therapy with "off-the-shelf" aNK cells in patients with refractory/relapsed AML. These data provide the foundation for future combination immunotherapy trials and for the optimization of aNK cell based therapies in patients with AML."

Journal • Acute Myelogenous Leukemia • Biosimilar • Hematological Malignancies • Leukemia • Oncology

Low-dose IL-2 ( Interleukin-2) Treatment in Macrophage Activation Syndrome（MAS） (clinicaltrials.gov) - P1/2; N=6; Recruiting; Sponsor: Peking University People's Hospital

New P1/2 trial • Biosimilar • Rheumatoid Arthritis

Viral Oncoprotein Targeted Autologous T Cell Therapy for Merkel Cell Carcinoma (clinicaltrials.gov) - P1/2; N=4; Terminated; Sponsor: Fred Hutchinson Cancer Research Center; Active, not recruiting ➔ Terminated; Trial primary completion date: Dec 2016 ➔ May 2016; A Phase I/II study (NCT01758458) is now recruiting

Trial primary completion date • Trial termination

Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By Aldesleukin and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer (clinicaltrials.gov) - P2; N=50; Completed; Sponsor: Fred Hutchinson Cancer Research Center; N=70 ➔ 50

Clinical • Enrollment change

Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By Aldesleukin and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer (clinicaltrials.gov) - P2; N=50; Completed; Sponsor: Fred Hutchinson Cancer Research Center; Active, not recruiting ➔ Completed

Clinical • Trial completion

CD8+ T Cell Therapy and Pembrolizumab in Treating Patients With Metastatic Gastrointestinal Tumors (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Dec 2022 ➔ Aug 2024; Trial primary completion date: Dec 2022 ➔ Aug 2024

Clinical • PD(L)-1 Biomarker • Trial completion date • Trial primary completion date

Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Previously Treated With Donor Stem Cell Transplant (clinicaltrials.gov) - P1/2; N=45; Active, not recruiting; Sponsor: Fred Hutchinson Cancer Research Center; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • IO Biomarker

Laboratory-Treated (Central Memory/Naive) CD8+ T Cells in Treating Patients With Newly Diagnosed or Relapsed Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2; N=9; Active, not recruiting; Sponsor: Fred Hutchinson Cancer Research Center; Recruiting ➔ Active, not recruiting; N=35 ➔ 9

Clinical • Enrollment change • Enrollment closed

Gene-Modified T Cells, Vaccine Therapy, and Ipilimumab in Treating Patients With Locally Advanced or Metastatic Malignancies (clinicaltrials.gov) - P1; N=4; Terminated; Sponsor: Jonsson Comprehensive Cancer Center; N=12 ➔ 4; Trial completion date: Jul 2020 ➔ Dec 2018; Recruiting ➔ Terminated; Trial primary completion date: Jul 2019 ➔ Dec 2018; low accrual

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination

Bispecific Antibody Armed Activated T-cells With Aldesleukin and Sargramostim in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1/2; N=2; Active, not recruiting; Sponsor: Barbara Ann Karmanos Cancer Institute; Trial completion date: Dec 2018 ➔ Dec 2020; Trial primary completion date: Dec 2018 ➔ Dec 2020

Clinical • Combination therapy • IO Biomarker • Trial completion date • Trial primary completion date

Activated T Cells Armed With GD2 Bispecific Antibody in Children and Young Adults With Neuroblastoma and Osteosarcoma (clinicaltrials.gov) - P1/2; N=40; Recruiting; Sponsor: University of Virginia; Trial completion date: May 2018 ➔ Dec 2019; Trial primary completion date: May 2018 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date

NY-ESO-1 TCR Engineered T Cell and HSC After Melphalan Conditioning Regimen in Treating Participants With Recurrent or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Roswell Park Cancer Institute; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant (clinicaltrials.gov) - P2; N=45; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

ACTolog in Patients With Solid Cancers (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Immatics US, Inc.; N=31 ➔ 20

Clinical • Combination therapy • Enrollment change

Study of IL-22 IgG2-Fc (F-652) for Subjects With Grade II-IV Lower GI aGVHD (clinicaltrials.gov) - P2a; N=27; Active, not recruiting; Sponsor: Generon (Shanghai) Corporation Ltd.; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2018 ➔ Dec 2019

Clinical • Combination therapy • Enrollment closed • Trial completion date