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

A Phase II Study of Adjuvant Immunotherapy Targeting KRAS G12D, KRAS G12V, or TP53 R175H for Participants With Advanced Gastrointestinal Malignancies

Phase 2

Not yet recruiting

Conditions: Gastrointestinal Carcinoma
Pancreatic Cancer
Hepatocellular Cancer
Cholangiocarcinoma
Duodenal Cancer
Colorectal Cancer
Small Bowel Cancer
Metastatic Cancers

Interventions: Biological: KRAS TCR-Transduced PBL
Drug: Aldesleukin
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2024-11-15

Last Posted Date: 2025-01-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 65

Registration Number: NCT06690281

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

Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer

Phase 1

Recruiting

Conditions: Non-Small Cell Lung Cancer
Gastrointestinal Cancer
Ovarian Cancer
Metastatic Solid Cancers
Colorectal Cancer
Breast Cancer
Genitourinary Cancer

Interventions: Drug: Aldesleukin
Drug: Fludarabine
Drug: Cyclophosphamide
Biological: KRAS TCR-Transduced PBL
Biological: GRT-C903/GRT-R904

First Posted Date: 2024-02-12

Last Posted Date: 2025-01-01

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 210

Registration Number: NCT06253520

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

A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer

Phase 1

Recruiting

Conditions: Triple Negative Breast Cancer

Interventions: Biological: Aldesleukin
Biological: Anti-HLA-A2/NY-ESO-1 TCR-transduced Autologous T Lymphocytes
Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Cyclophosphamide
Procedure: Echocardiography
Drug: Fludarabine
Procedure: Leukapheresis
Procedure: Magnetic Resonance Imaging
Procedure: Mammogram
Procedure: Multigated Acquisition Scan
Procedure: Ultrasound Imaging

First Posted Date: 2023-08-14

Last Posted Date: 2025-01-01

Lead Sponsor: University of Southern California

Target Recruit Count: 20

Registration Number: NCT05989828

Locations: 🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma

Phase 2

Recruiting

Conditions: Advanced Locoregional Melanoma
Metastatic Melanoma
Metastatic Renal Cell Carcinoma
Clear Cell Histology

Interventions: Drug: Pembrolizumab
Drug: Aldesleukin

First Posted Date: 2021-12-13

Last Posted Date: 2024-12-05

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 78

Registration Number: NCT05155033

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

Ciclosporin Followed by Low-dose IL-2 in Patients with Recently Diagnosed Type 1 Diabetes

Phase 2

Recruiting

Conditions: Type 1 Diabetes

Interventions: Drug: Cyclosporin
Drug: ILT101
Drug: Placebo

First Posted Date: 2021-12-10

Last Posted Date: 2024-11-21

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 24

Registration Number: NCT05153070

Locations: 🇫🇷
Lorenzon Roberta, Paris, France

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated or Viral Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab

Phase 2

Withdrawn

Conditions: Metastatic HPV-16 Positive Squamous Cell Anal Cancer

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

First Posted Date: 2020-09-03

Last Posted Date: 2021-02-01

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT04536922

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

Low Dose of IL-2 In Acute Respiratory DistrEss Syndrome Related to COVID-19

Phase 2

Completed

Conditions: COVID 19

First Posted Date: 2020-04-22

Last Posted Date: 2021-10-04

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 30

Registration Number: NCT04357444

Locations: 🇫🇷
Service Anesthésie Réanimation - Groupe Hospitalier Pitié-Salpêtrière, Paris, France

Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder

Phase 2

Completed

Conditions: Bipolar Depression

Interventions: Drug: Placebos
Drug: ILT101

First Posted Date: 2019-10-21

Last Posted Date: 2023-08-08

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 15

Registration Number: NCT04133233

Locations: 🇫🇷
Pr Marion Leboyer, Créteil, Hôpital Albert Chenevier, France

Non-Viral TCR Gene Therapy

Phase 2

Withdrawn

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

Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Aldesleukin
Biological: Sleeping Beauty Transposed PBL

First Posted Date: 2019-09-25

Last Posted Date: 2024-03-12

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT04102436

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

Low-dose IL-2 to the Kinetics of Regulatory T-cell in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Placebo
Drug: ILT101

First Posted Date: 2019-02-11

Last Posted Date: 2021-12-30

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 40

Registration Number: NCT03837093

Locations: 🇫🇷
Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris, Paris, France

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