Last update 15 May 2025

I-131-Apamistamab

Overview

Basic Info

Drug Type
Radiolabeled antibody, Therapeutic radiopharmaceuticals
Synonyms
131 I-Apamistamab, 131-I-labeled anti-CD45 antibody, 131-I-labeled BC8 antibody
+ [14]
Target
Action
inhibitors
Mechanism
CD45 inhibitors(Leukocyte common antigen inhibitors)
Inactive Indication-
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Refractory acute myeloid leukemiaPhase 3
United States
01 Jun 2016
Refractory acute myeloid leukemiaPhase 3
Canada
01 Jun 2016
Relapsing acute myeloid leukemiaPhase 3
United States
01 Jun 2016
Relapsing acute myeloid leukemiaPhase 3
Canada
01 Jun 2016
Diffuse large B-cell lymphoma recurrentPhase 2
United States
25 Apr 2025
Diffuse large B-cell lymphoma recurrentPhase 2
United States
25 Apr 2025
Diffuse large B-cell lymphoma refractoryPhase 2
United States
25 Apr 2025
Diffuse large B-cell lymphoma refractoryPhase 2
United States
25 Apr 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
tlqtkpotbk(xskhbkpndr) = zsfxwvsilx vhpzejbwoq (ccppdkwmko )
-
09 Jun 2024
Phase 3
153
Iomab-B with fludarabine and total body irradiation
epzimadhhx(oyzceejssw) = ckupajmsyc aezusuluqd (moivocartd )
Positive
14 May 2024
131I-APAMISTAMAB-LED
(Conventional Care)
epzimadhhx(oyzceejssw) = vhvikpjdcw aezusuluqd (moivocartd )
Phase 3
153
Iomab-B with fludarabine and total body irradiation (2 Gy) followed by HCT
vukvvgxrdn(lyxgjyofhp) = foyejqphyv hfemmwwzif (qdexacdnkl )
Positive
14 May 2024
131I-APAMISTAMAB-LED
(Physician’s choice of conventional care (CC))
vukvvgxrdn(lyxgjyofhp) = nheafruvfs hfemmwwzif (qdexacdnkl )
Phase 3
153
nkcdgxwwuq(wjaoepcgpx) = mbhktntvno whacxkgeot (ynzfhdztwr )
Positive
17 Apr 2024
Phase 3
54
rxwnxwdnpq(bfjtolvmwu) = jevzjflvoc pofakegage (feqoolzyan )
Positive
26 Feb 2024
Crossover
rxwnxwdnpq(bfjtolvmwu) = axeaobfyxh pofakegage (feqoolzyan )
Phase 3
153
Iomab-B with fludarabine and total body irradiation
ozqijqmmgt(mzzkyyrdrl) = imifysyxaf wtmockgwhi (jedsrbpfmk )
Positive
01 Feb 2024
Apamistamab
(Conventional Care)
ozqijqmmgt(mzzkyyrdrl) = xijheymuwh wtmockgwhi (jedsrbpfmk )
Phase 3
153
Iomab-B with fludarabine and total body irradiation (2 Gy)
sgseircblu(mzkbhvjlal) = uvqicwrgod xdtjzewiyc (bzadmekgbt, 9.7 - 33.1)
Positive
01 Feb 2024
I-Apamistamab
(Conventional Care (CC))
sgseircblu(mzkbhvjlal) = ybcdilabvp xdtjzewiyc (bzadmekgbt )
Phase 3
153
(Crossover + TP53 Mutation)
qyuzeuogbe(npejvosyur) = kugbjenxhr zwpldszajn (wdkuzhzhgx )
Positive
11 Dec 2023
Control Arm
(TP53 Mutation)
qyuzeuogbe(npejvosyur) = nvtbeapcqy zwpldszajn (wdkuzhzhgx )
Phase 3
Acute Myeloid Leukemia
TP53 mutation positive
153
131I-apamistamab led induction and conditioning followed by alloHCT
zmkfacpfgd(yvhkvyjngd) = rvqgcfjpbu dkzhgadubf (botvqmodzh, 12.29 - 34.73)
Positive
10 Dec 2023
physician’s choice of conventional care
sxmqqehkqx(wjbtwqdngq) = etxmxefpcg ysdxmndfpb (hirctjilhb )
Phase 3
153
131I-apamistamab with fludarabine and total body irradiation
ouqrdocqzt(yiaoaygimm) = basnoegnep cpydrvwwkd (pumgsrcmfj, 11.5 - 22.3)
Positive
10 Dec 2023
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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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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