Aldesleukin

Generic Name: Aldesleukin

Brand Names: Proleukin

Drug Type: Biotech

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)

Clinical Trials

E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers

Phase 2

Recruiting

Conditions: Anal Cancer
Vulva Cancer
Metastatic Cancer
HPV-Related Squamous Cell Carcinoma
HPV-Related Adenocarcinoma
HPV-Associated Vaginal Adenocarcinoma
HPV-Related Anal Squamous Cell Carcinoma
HPV-Related Penile Squamous Cell Carcinoma
HPV-Related Malignancy
HPV-Related Cervical Carcinoma

Interventions: Biological: E7 TCR-T cells
Drug: Aldesleukin

First Posted Date: 2023-01-17

Last Posted Date: 2025-03-30

Lead Sponsor: Christian Hinrichs

Target Recruit Count: 20

Registration Number: NCT05686226

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States

E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

Phase 1

Recruiting

Conditions: Oropharynx Cancer
HPV-Associated Cervical Carcinoma
HPV-Related Carcinoma
HPV-Related Malignancy
HPV Positive Oropharyngeal Squamous Cell Carcinoma
HPV-Related Adenocarcinoma
HPV-Related Adenosquamous Carcinoma
HPV-Related Squamous Cell Carcinoma
HPV-Related Penile Squamous Cell Carcinoma
HPV-Related Endocervical Adenocarcinoma

Interventions: Biological: E7 TCR-T cells
Drug: Aldesleukin

First Posted Date: 2022-12-07

Last Posted Date: 2025-03-30

Lead Sponsor: Christian Hinrichs

Target Recruit Count: 15

Registration Number: NCT05639972

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States

CISH Inactivated TILs in the Treatment of NSCLC

Phase 1

Not yet recruiting

Conditions: Metastatic Non Small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Squamous Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma of Lung
Large Cell Lung Cancer

Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Biological: CISH Inactivated TIL
Drug: Aldesleukin
Drug: Pembrolizumab

First Posted Date: 2022-10-04

Last Posted Date: 2022-12-09

Lead Sponsor: Intima Bioscience, Inc.

Target Recruit Count: 70

Registration Number: NCT05566223

Locations: 🇺🇸
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States
🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States

Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer

Early Phase 1

Recruiting

Conditions: Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC V8
Stage IVA Lung Cancer AJCC V8
Stage IVB Lung Cancer AJCC V8

Interventions: Biological: Aldesleukin
Biological: Pembrolizumab

First Posted Date: 2022-08-09

Last Posted Date: 2025-04-01

Lead Sponsor: Emory University

Target Recruit Count: 15

Registration Number: NCT05493566

Locations: 🇺🇸
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States

KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer

Phase 1

Recruiting

Conditions: Gastric Cancer
Cervical Cancer
Breast Cancer
Lung Cancer

Interventions: Biological: KK-LC-1 TCR-T cells
Drug: Aldesleukin

First Posted Date: 2022-08-02

Last Posted Date: 2025-03-30

Lead Sponsor: Christian Hinrichs

Target Recruit Count: 30

Registration Number: NCT05483491

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States

Therapeutic Evaluation of Low-dose IL-2-based Immunomodulatory Approach in Patients With Early AD

Phase 2

Recruiting

Conditions: Alzheimer Disease

Interventions: Drug: Placebo
Drug: Proleukin

First Posted Date: 2022-07-21

Last Posted Date: 2024-06-12

Lead Sponsor: Centre Hospitalier St Anne

Target Recruit Count: 45

Registration Number: NCT05468073

Locations: 🇫🇷
GHU Saint Anne, Paris, France

Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients with Advanced Solid Tumors

Phase 1

Active, not recruiting

Conditions: Solid Tumor, Adult

Interventions: Drug: ICT01
Drug: Proleukin Injectable Product
Drug: Pembrolizumab injection

First Posted Date: 2022-04-01

Last Posted Date: 2025-03-28

Lead Sponsor: ImCheck Therapeutics

Target Recruit Count: 56

Registration Number: NCT05307874

Locations: 🇫🇷
IUCT Oncopole Claudius Regaud, Toulouse, France
🇩🇪
University Carl Gustav Carus, Dresden, Germany
🇩🇪
Universitätsklinikum Wuerzburg, Wuerzburg, Germany

and more 2 locations

Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers

Phase 1

Recruiting

Conditions: Ovary Cancer
Non Small Cell Lung Cancer
Sarcoma,Soft Tissue
Melanoma Stage IV
Sarcoma, Synovial
Metastatic Cancer
Bladder Urothelial Carcinoma
Triple Negative Breast Cancer
Neuroblastoma, Metastatic

Interventions: Drug: CYCLOPHOSPHAMIDE and FLUDARABIN
Drug: Cyclophosphamide
Biological: HBI 0201-ESO TCRT
Drug: Aldesleukin

First Posted Date: 2022-03-25

Last Posted Date: 2023-09-25

Lead Sponsor: Hadassah Medical Organization

Target Recruit Count: 3

Registration Number: NCT05296564

Locations: 🇮🇱
Hadassah Medical Organization, Jerusalem, Israel

Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

Phase 1

Recruiting

Conditions: Advanced Solid Tumor
Metastatic Cancer

Interventions: Drug: AU-007
Drug: Aldesleukin
Drug: Avelumab
Drug: Nivolumab

First Posted Date: 2022-03-04

Last Posted Date: 2025-04-06

Lead Sponsor: Aulos Bioscience, Inc.

Target Recruit Count: 159

Registration Number: NCT05267626

Locations: 🇺🇸
University of Utah - Huntsman Cancer Institute, Salt Lake City, Utah, United States
🇦🇺
Southern Oncology Clinical Research Unit, Bedford Park, South Australia, Australia
🇺🇸
START Midwest, Grand Rapids, Michigan, United States

and more 10 locations

CYNK-101 in Combination with Trastuzumab and Pembrolizumab in Patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma

Phase 1

Terminated

Conditions: Metastatic HER2 Positive Gastroesophageal Junction Cancer

Interventions: Biological: CYNK-101
Drug: Pembrolizumab
Drug: Trastuzumab
Drug: Recombinant Human Interleukin-2
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Mesna

First Posted Date: 2022-01-26

Last Posted Date: 2024-12-12

Lead Sponsor: Celularity Incorporated

Target Recruit Count: 1

Registration Number: NCT05207722

Locations: 🇺🇸
Georgetown, Washington, District of Columbia, United States
🇺🇸
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
Scripps Health, La Jolla, California, United States

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