interleukin-2 · cytokine

aldesleukin

5 active trials across 8 of our biomarkers, targeting IL-2 receptor. Not approved for any biomarker on marked.bio yet.

Also known as Proleukin.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

Biomarker	Active trials	All trials	Furthest active phase
KRAS G12C	3	7	Phase 1/2
KRAS G12D	3	7	Phase 1/2
ALK fusion	1	1	Phase 1/2
BRAF V600E	1	8	Phase 1/2
FLT3 mutation (ITD/TKD)	1	2	Phase 1
EGFR exon 19 deletion / L858R	0	1	–
MET exon 14 skipping	0	1	–
RET fusion or mutation	0	1	–

Trials

5 of 18 trials shown

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

Recruiting Phase 1/2 Aulos Bioscience Started 2022Primary completion 2027-02 NCT05267626

AU-007aldesleukinavelumabnivolumab

BRAF mutation: patients who refused BRAF+MEK inhibitor

BRAF V600EALK fusionAdvanced Solid Tumor, Metastatic Cancer, Cutaneous Melanoma, Non-Small Cell Lung Cancer
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients

Recruiting Phase 1/2 National Cancer Institute (NCI) Started 2017Primary completion 2027-06 NCT03190941

cyclophosphamidefludarabineAnti-KRAS G12V mTCR PBLaldesleukin

…surable (per RECIST V1.1 criteria, metastatic, or unresectable malignancy expressing G12V mutated KRAS as assessed by one of the following methods: RT-PCR on tumor tissue, tumor DNA sequencing…

KRAS G12CKRAS G12DPancreatic Cancer, Gastric Cancer, Gastrointestinal Cancer, Colon Cancer
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies

Recruiting Phase 1 National Cancer Institute (NCI) Started 2026Primary completion 2029-04 NCT06904066

aldesleukincyclophosphamidefludarabineIndividual Patient TCR-Transduced PBL

RAS mutations can be in NRAS, KRAS or HRAS as these oncogenes have the same amino acid sequence at the…

KRAS G12CKRAS G12DMalignancy, Hematologic, Neoplasms, Hematologic, Neoplasms, Hematopoietic, Blood Cancer
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

Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2024Primary completion 2029-02 NCT06253520

aldesleukinfludarabinecyclophosphamideKRAS TCR-Transduced PBLGRT-C903/GRT-R904

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

KRAS G12CKRAS G12DMetastatic Solid Cancers, Colorectal Cancer, Breast Cancer, Non-Small Cell Lung Cancer
CIML NK Cells With Venetoclax for AML

Recruiting Phase 1 Dana-Farber Cancer Institute Started 2024Primary completion 2026-11 NCT06152809

Cytokine-Induced Memory-like Natural Killer Cellsaldesleukinvenetoclax

…ditional mutations associated with acquired resistance to venetoclax: Mutated NRAS, KRAS, FLT3 ITD/TKD

FLT3 mutation (ITD/TKD)Acute Myeloid Leukemia, Acute Myeloid Leukemia Recurrent, Leukemia, Leukemia, Myeloid
HD IL-2 + Vemurafenib in Patients With BRAF Mutation Positive Metastatic Melanoma

Terminated Phase 4 Clinigen Started 2012 NCT01683188

vemurafenib FDA EUaldesleukin

Confirmed and measurable metastatic melanoma with the BRAFV600 mutation.

BRAF V600EMetastatic Melanoma
A Phase II Study of Adjuvant Immunotherapy Targeting KRAS G12D, KRAS G12V, or TP53 R175H for Participants With Advanced Gastrointestinal Malignancies

Withdrawn Phase 2 National Cancer Institute (NCI) Started 2025 NCT06690281

KRAS TCR-Transduced PBLaldesleukinfludarabinecyclophosphamide

KRAS G12D mutation plus HLA-A\*11:01

KRAS G12DGastrointestinal Carcinoma, Pancreatic Cancer, Hepatocellular Cancer, Cholangiocarcinoma
CISH Inactivated TILs in the Treatment of NSCLC

Withdrawn Phase 1/2 Intima Bioscience Started 2023 NCT05566223

fludarabinecyclophosphamideCISH Inactivated TILaldesleukinpembrolizumab

…ymphoma kinase \[ALK\], reactive oxygen species \[ROS\], Kirsten RAt Sarcoma Virus G12C \[KRAS G12C\], human epidermal growth factor receptor 2 \[HER2\], neurotrophic tyrosine receptor kina…

KRAS G12CBRAF V600EMET exon 14 skippingRET fusion or mutationCarcinoma, Non-Small-Cell Lung, Metastatic Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Squamous Cell Lung Cancer
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients

Terminated Phase 1/2 National Cancer Institute (NCI) Started 2019 NCT03745326

cyclophosphamidefludarabinealdesleukinanti-Kirsten rat sarcoma virus (KRAS) Glycine(G) to Aspartic Acid(D) substitutio

…ia in Solid Tumors v1.1 criteria), metastatic, or unresectable malignancy expressing G12D mutated KRAS as assessed by one of the following methods: Reverse Transcription Polymerase Chain React…

KRAS G12CKRAS G12DGastrointestinal Cancer, Pancreatic Cancer, Gastric Cancer, Colon Cancer
Genetically Modified T Cells in Treating Patients With Stage III-IV Non-small Cell Lung Cancer or Mesothelioma

Terminated Phase 1/2 Fred Hutchinson Cancer Center Started 2015 NCT02408016

aldesleukinAutologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytescyclophosphamide

ELIGIBILITY FOR TREATMENT ON ARM 1: NSCLC patients with a mutation in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) must have demonstrated progression or intolerance to…

EGFR exon 19 deletion / L858RAdvanced Pleural Malignant Mesothelioma, HLA-A*0201 Positive Cells Present, Recurrent Non-Small Cell Lung Carcinoma, Recurrent Pleural Malignant Mesothelioma
Combined BRAF-Targeted Therapy & Immunotherapy for Melanoma

Terminated Phase 2 Massachusetts General Hospital Started 2013 NCT01754376

aldesleukinvemurafenib FDA EU

Histologically confirmed metastatic or unresectable melanoma with V600E mutation

BRAF V600EMelanoma
Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies

Completed Phase 1/2 M.D. Anderson Cancer Center Started 2013 NCT01823198

aldesleukinAllogeneic CD56-positive CD3-negative Natural Killer CellsBusulfanfludarabine

Presence of high risk molecular abnormalities including FLT3 mutations, DNMT3A, TET2

FLT3 mutation (ITD/TKD)Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Erythroid Leukemia, Acute Megakaryoblastic Leukemia, Acute Myeloid Leukemia
Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma

Completed Phase 2 H. Lee Moffitt Cancer Center and Research Institute Started 2012 NCT01659151

aldesleukinvemurafenib FDA EUfludarabinecyclophosphamide

Tumor must have a B-RAF V600E, D or K mutation by pyrosequencing, Cobas assay, or equivalent (43)

BRAF V600EMetastatic Melanoma
Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors

Completed Phase 2 National Cancer Institute (NCI) Started 1997 NCT00019331

aldesleukinras peptide cancer vaccinesargramostimDetoxPC

Ras mutations must be one of the following point mutations at codon 12:

KRAS G12CKRAS G12DColorectal Cancer, Endometrial Cancer, Head and Neck Cancer, Liver Cancer
Vaccine Therapy and Biological Therapy in Treating Patients With Advanced Cancer

Completed Phase 2 National Cancer Institute (NCI) Started 1996 NCT00019084

aldesleukinmutant p53 peptide pulsed dendritic cell vaccineras peptide cancer vaccinesargramostimtherapeutic autologous lymphocytestherapeutic tumor infiltrating lymphocytes

… expressing mutant p53 or ras, e.g.: Lung Pancreatic Breast Colon Cervical Ovarian p53 or ras mutation by point mutation, insertion, or deletion in protein-coding sequence Tumor tissue require…

KRAS G12CKRAS G12DBreast Cancer, Cervical Cancer, Colorectal Cancer, Lung Cancer
STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Cancer, Renal Cell Cancer, Cervical Cancer and Melanoma

Withdrawn Phase 1 City of Hope Medical Center Started 2025 NCT06626256

aldesleukincyclophosphamidefludarabineTherapeutic Tumor Infiltrating Lymphocytes

…s need to have received prior PD1 therapy and BRAF inhibitor treatment in patients with a V600E mutation

BRAF V600ELocally Advanced Cervical Carcinoma, Locally Advanced Colorectal Carcinoma, Locally Advanced Malignant Solid Neoplasm, Locally Advanced Melanoma
Vemurafenib and White Blood Cell Therapy for Advanced Melanoma

Terminated Phase 1 National Cancer Institute (NCI) Started 2012 NCT01585415

vemurafenib FDA EUYoung TILcyclophosphamidefludarabinealdesleukin

Measurable metastatic melanoma that expresses the VtoE BRAF mutation and VtoK BRAF mutation assessed in a CLIA certified laboratory.

BRAF V600EMetastatic Cancer, Melanoma
Ipilimumab With Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Melanoma Mets Pts

Completed No phase H. Lee Moffitt Cancer Center and Research Institute Started 2012 NCT01701674

ipilimumabAdministration of LymphodepletioncyclophosphamidefludarabinealdesleukinAdoptive Cell Therapy with TIL

Tumor may have a B-RAF V600 mutation or be BRAF wild type, and patients must not have been previously treated with ipilimumab

BRAF V600EMetastatic Melanoma

Biomarkers

Sponsors

Trials