Aldesleukin

Generic Name: Aldesleukin

Brand Names: Proleukin

Drug Type: Biotech

Chemical Formula: -

CAS Number: 110942-02-4

Unique Ingredient Identifier: M89N0Q7EQR

Background: Aldesleukin, a lymphokine, is produced by recombinant DNA technology using a genetically engineered E. coli strain containing an analog of the human interleukin-2 gene. Genetic engineering techniques were used to modify the human IL-2 gene, and the resulting expression clone encodes a modified human interleukin-2. This recombinant form differs from native interleukin-2 in the following ways: a) Aldesleukin is not glycosylated because it is derived from E. coli; b) the molecule has no N-terminal alanine; the codon for this amino acid was deleted during the genetic engineering procedure; c) the molecule has serine substituted for cysteine at amino acid position 125.

Indication: For treatment of adults with metastatic renal cell carcinoma.

Associated Conditions: Metastatic Melanoma, Metastatic Renal Cell Carcinoma ( mRCC)

Associated Therapies: -

Clinical Trials

Safety and Efficacy of Low-dose IL-2 in Birch Pollen Allergy

Phase 2

Completed

Conditions: Allergic Rhinoconjunctivitis to Birch Pollen
With a Positive Skin Prick Test to Birch Pollen

Interventions: Drug: ILT-101 ld-(IL2)

First Posted Date: 2018-12-17

Last Posted Date: 2023-12-04

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 24

Registration Number: NCT03776643

Locations: 🇫🇷
CIC Biothérapies - Service de Biothérapies, Paris, Groupe Hospitalier Pitié-Salpêtrière 47 -83 BD DE L'hopital, France
🇫🇷
Centre d'essais cliniques, ALYATEC, Strasbourg, Environmental Exposure Chamber, Alyatec, 1 Place De L'hôpital, France

Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients

Phase 1

Recruiting

Conditions: Rectal Cancer
Colon Cancer
Gastric Cancer
Gastrointestinal Cancer
Pancreatic Cancer

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Aldesleukin
Biological: anti-KRAS G12D mTCR PBL

First Posted Date: 2018-11-19

Last Posted Date: 2024-11-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 70

Registration Number: NCT03745326

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer

Phase 2

Recruiting

Conditions: Non-Small Cell Lung Cancer
Breast Cancer
Ovarian Cancer
Gastrointestinal/Genitourinary Cancers
Endocrine Tumors
Neuroendocrine Tumors
Multiple Myeloma

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Aldesleukin
Biological: Individual Patient TCR-Transduced PBL
Drug: Pembrolizumab (KEYTRUDA )

First Posted Date: 2018-01-29

Last Posted Date: 2024-12-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 270

Registration Number: NCT03412877

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Immunotherapy With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions

Phase 1

Terminated

Conditions: Human Papillomavirus
HPV-16
High Grade Squamous Intraepithelial Lesion

Interventions: Drug: Aldesleukin
Biological: E6 T Cell Receptor (TCR)

First Posted Date: 2017-06-23

Last Posted Date: 2021-02-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1

Registration Number: NCT03197025

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients

Phase 1

Recruiting

Conditions: Pancreatic Cancer
Gastric Cancer
Colon Cancer
Rectal Cancer
Gastrointestinal Cancer

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Biological: Anti-KRAS G12V mTCR PBL
Drug: Aldesleukin

First Posted Date: 2017-06-19

Last Posted Date: 2024-12-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 110

Registration Number: NCT03190941

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

E7 TCR T Cells for Human Papillomavirus-Associated Cancers

Phase 1

Recruiting

Conditions: Cervical Intraepithelial Neoplasia
Vulvar Neoplasms
Papillomavirus Infections
Carcinoma In Situ
Vulvar Diseases

Interventions: Biological: E7 TCR cells
Drug: Aldesleukin
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2016-08-08

Last Posted Date: 2024-12-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 180

Registration Number: NCT02858310

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers

Phase 1

Recruiting

Conditions: Renal Cell Cancer
Breast Cancer
Melanoma
Pancreatic Cancer
Ovarian Cancer

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Aldesleukin
Biological: Anti-hCD70 CAR transduced PBL

First Posted Date: 2016-07-13

Last Posted Date: 2024-11-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 124

Registration Number: NCT02830724

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

A Prospective Randomized and Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab

Phase 2

Suspended

Conditions: Melanoma

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Aldesleukin
Biological: young TIL
Drug: Pembrolizumab

First Posted Date: 2015-12-03

Last Posted Date: 2024-11-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT02621021

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

In Vivo Persistence of Adoptively-Transferred TIL Cultured With Akti in People With Metastatic Melanoma

Phase 1

Withdrawn

Conditions: Metastatic Melanoma

Interventions: Biological: AKTi-treated TIL
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Aldesleukin

First Posted Date: 2015-07-03

Last Posted Date: 2017-07-27

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT02489266

Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing Human Thyroglobulin to People With Thyroglobulin Expressing Thyroid Cancer

Phase 1

Withdrawn

Conditions: Metastatic Thyroid Cancer

Interventions: Drug: Aldesleukin
Drug: Fludarabine
Drug: Cyclophosphamide
Biological: Anti-Thyroglobulin mTCR PBL

First Posted Date: 2015-03-18

Last Posted Date: 2019-12-16

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT02390739

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