Last update 05 Aug 2026

ICT-01

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Humanized anti-butyrophilin-3A (ImCheck), ICT01 - ImCheck Therapeutics, ICT 01
+ [2]
Target
Action
inhibitors
Mechanism
BTN3A1 inhibitors(butyrophilin subfamily 3 member A1 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 2/3
First Approval Date-
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Myeloid LeukemiaPhase 3-01 Nov 2026
Acute Lymphoblastic LeukemiaPhase 2
United States
-05 Mar 2020
Acute Lymphoblastic LeukemiaPhase 2
Belgium
-05 Mar 2020
Acute Lymphoblastic LeukemiaPhase 2
France
-05 Mar 2020
Acute Lymphoblastic LeukemiaPhase 2
Germany
-05 Mar 2020
Acute Lymphoblastic LeukemiaPhase 2
Spain
-05 Mar 2020
Acute Lymphoblastic LeukemiaPhase 2
United Kingdom
-05 Mar 2020
Advanced cancerPhase 2
United States
-05 Mar 2020
Advanced cancerPhase 2
Belgium
-05 Mar 2020
Advanced cancerPhase 2
France
-05 Mar 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
54
ICT01LOW
cikhuesozj(bzbnizotye) = yqujcallzx yzjkaxjmbb (xhhwuvheao, 54 - 85)
Positive
22 Mar 2026
cikhuesozj(bzbnizotye) = nipzubqbso yzjkaxjmbb (xhhwuvheao, 20 - 70)
Phase 1/2
57
ICT01LOW
nijofdxjzp(avdnnxycpu) = qwrcnwbhyf edwqurjagt (fggthfxqid, 51 - 82)
Positive
06 Dec 2025
nijofdxjzp(avdnnxycpu) = zsdqiwqyyx edwqurjagt (fggthfxqid, 20 - 70)
Phase 1/2
45
AV plus 10 mg ICT01
ooktxnzyjd(moxugiuidw) = All pts had at least one adverse event; 30-day mortality was 3% mkeieevjer (vnsuuapdsd )
Positive
30 May 2025
Not Applicable
-
cdvwaakzow(cqkygmnrfw) = All patients had at least one TEAE. Most common Grade 3 or 4 TEAEs were neutropenia (56%), febrile neutropenia (38%), and thrombocytopenia (38%). Grade 3/4 febrile neutropenia for ICT01lowor ICT01highwas seen in 2 (25%) and 5 (63%) patients, respectively. jrggnlgsbm (ntmiifckmu )
-
08 Dec 2024
Phase 1
Refractory Melanoma
BTN3A tumor expression
19
ICT01 2-200 mg + Pembrolizumab 200 mg
jnlwczauth(bxyiavdnbl) = 31% hxbcvhpsmi (spwnncxgzz )
Positive
05 Nov 2024
Phase 1
Transitional Cell Carcinoma
BTN3A tumor expression
26
ICT01 7 mg + Pembrolizumab 200 mg
wyvwqqubns(xrzkuvpkit) = 71% ujuhexgibi (gffakotczs )
Positive
05 Nov 2024
ICT01 200 mg + Pembrolizumab 200 mg
Phase 1/2
Refractory Melanoma
PD-1 | IFNg | BTN3A ...
35
ICT01 + Pembrolizumab
bnfxxfdufe(holitfkblu) = dmsghuzmrz wsiswgweec (wqvhzlqbgk )
Positive
24 May 2024
Phase 2
-
ICT01 + Venetoclax + Azacitidine
ubjdkndrci(izgzpxunpd) = udvatwpboh hnqlavxnmu (qpjraquped )
-
09 Dec 2023
Phase 1/2
-
ntnehlxcus(wrskenghwh) = Treatment-related adverse events were mainly mild to moderate infusion-related reactions, comparable to those observed with ICT01 or IL-2 monotherapy bfbrdaisib (jayspgajjt )
Positive
02 Nov 2023
Phase 1/2
26
fdtedndqws(ftjryqisev) = rmhonkwjda budutkpllv (ctdzzzsbjk )
Positive
22 Oct 2023
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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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