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DRUG CLASS:

IL-2 stimulant

4d
APHP251137: THERIPEX (2025-523305-15-00)
P1, N=5, Not yet recruiting, Assistance Publique Hopitaux De Paris
New P1 trial
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FOXP3 (Forkhead Box P3)
4d
A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus (clinicaltrials.gov)
P1, N=40, Completed, Cugene Inc. | Active, not recruiting --> Completed
Trial completion
6d
Evaluating pegenzileukin (SAR444245/THOR-707) in combination with pembrolizumab or cetuximab in advanced metastatic gastrointestinal cancer: the PEGATHOR phase 2 study. (PubMed, Invest New Drugs)
The biomarker data supported the mechanism of action involving the upregulation of CD8+ T cells and NK cells. ClinicalTrials.gov Identifier: NCT05104567.
P2 data • Journal • PD(L)-1 Biomarker
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CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
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Keytruda (pembrolizumab) • Erbitux (cetuximab) • pegenzileukin (SAR444245)
10d
CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=23, Terminated, Cullinan Therapeutics Inc. | N=86 --> 23 | Trial completion date: Jun 2028 --> Jun 2026 | Recruiting --> Terminated | Trial primary completion date: Jun 2028 --> Jun 2026; Company decision
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • First-in-human
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Keytruda (pembrolizumab) • CLN-617
12d
Interleukine-2 (IL-2) Plus Semaglutide in Alzheimer's Disease (clinicaltrials.gov)
P1/2, N=30, Recruiting, The Methodist Hospital Research Institute
New P1/2 trial
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IL2 (Interleukin 2)
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Proleukin (aldesleukin)
13d
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers (clinicaltrials.gov)
P1/2, N=124, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2028 --> Jan 2030 | Trial primary completion date: Jan 2027 --> Jan 2029
Trial completion date • Trial primary completion date
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cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
25d
A534260: IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma (clinicaltrials.gov)
P1/2, N=8, Terminated, University of Wisconsin, Madison | Trial completion date: Aug 2026 --> Dec 2025 | Active, not recruiting --> Terminated; Administrative
Trial completion date • Trial termination
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Opdivo (nivolumab) • Yervoy (ipilimumab) • lorukafusp alfa (APN301)
26d
L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC) (clinicaltrials.gov)
P2, N=180, Recruiting, Philogen S.p.A. | Not yet recruiting --> Recruiting | Initiation date: Feb 2026 --> Jun 2026
Enrollment open • Trial initiation date
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Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
30d
HCC 21-166: T-regulatory Cell Depletion With E7777 Combined With Pembrolizumab in Recurrent or Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=25, Active, not recruiting, Alexander B Olawaiye, MD | Recruiting --> Active, not recruiting | N=70 --> 25 | Trial completion date: Dec 2027 --> Dec 2030 | Trial primary completion date: Dec 2025 --> May 2030
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Checkpoint inhibition
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MSI (Microsatellite instability) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
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MSI-H/dMMR
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Keytruda (pembrolizumab) • Lymphir (denileukin diftitox-cxdl)
1m
Immune Correlates of Denileukin Diftitox Treatment in TFH-Type Lymphoma. (PubMed, Cancers (Basel))
TFH-type lymphomas were associated with higher FOXP3-positive cell density than selected non-TFH-type comparators. DD treatment may be associated with changes in tissue immune infiltrates and peripheral CD8/TCR Vβ skewing in responding cases, although these findings remain exploratory and do not establish causality.
Journal • IO biomarker
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CD8 (cluster of differentiation 8) • CD163 (CD163 Molecule) • CD4 (CD4 Molecule) • CD68 (CD68 Molecule) • FOXP3 (Forkhead Box P3)
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Ontak (denileukin diftitox)
1m
ANEMIL: Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment (clinicaltrials.gov)
P1/2, N=2, Terminated, University Hospital, Bordeaux | Completed --> Terminated; target number of inclusion not reached
Trial termination
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Proleukin (aldesleukin)
1m
Phase 1/2 study of pegenzileukin, a pegylated recombinant non-alpha IL-2, with cemiplimab for the treatment of advanced unresectable or metastatic skin cancers. (PubMed, J Immunother Cancer)
Pegenzileukin in combination with cemiplimab at the RP2D of 16 µg/kg showed a manageable safety profile and promising translational data supporting its mechanism of action.
Clinical • P1/2 data • Journal • PD(L)-1 Biomarker • First-in-human
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CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
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Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • pegenzileukin (SAR444245)