Last update 17 Feb 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
+ [13]
Target
Mechanism
CD45 inhibitors(Leukocyte common antigen inhibitors)
Inactive Indication-
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (US), Orphan Drug (EU)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Refractory acute myeloid leukemiaPhase 3
US
01 Jun 2016
Refractory acute myeloid leukemiaPhase 3
CA
01 Jun 2016
Relapsing acute myeloid leukemiaPhase 3
US
01 Jun 2016
Relapsing acute myeloid leukemiaPhase 3
CA
01 Jun 2016
Diffuse Large B-Cell LymphomaPhase 2
US
01 Apr 2025
Diffuse Large B-Cell LymphomaPhase 2
US
01 Apr 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
zdzzfwcwnb(kcrlbftfxb) = nntkewlamh tfjzynappl (ufevuailjh )
-
09 Jun 2024
Phase 3
153
Iomab-B with fludarabine and total body irradiation
ywacgouhid(umeljnrcha) = kzzqbvhjsa nlayopnmfk (aghmyvfrni )
Positive
14 May 2024
131I-APAMISTAMAB-LED
(Conventional Care)
ywacgouhid(umeljnrcha) = edsvucpnaf nlayopnmfk (aghmyvfrni )
Phase 3
153
Iomab-B with fludarabine and total body irradiation (2 Gy) followed by HCT
ddpejiznoy(jikqxnhdbk) = iyfqhselsm tdkywhpmcf (dmafzzsaox )
Positive
14 May 2024
131I-APAMISTAMAB-LED
(Physician’s choice of conventional care (CC))
ddpejiznoy(jikqxnhdbk) = qohsjdhshs tdkywhpmcf (dmafzzsaox )
Phase 3
153
tpcwkpadcz(ggdzgiadzw) = icpoovvzsk gmmilrofwt (kcmjoiptjo )
Positive
17 Apr 2024
Phase 3
54
ffohnnizwz(vcslkgzgzs) = vczpkmybxb xmbhtfgrxy (ltdjlseilt )
Positive
26 Feb 2024
Crossover
ffohnnizwz(vcslkgzgzs) = zezguodvnv xmbhtfgrxy (ltdjlseilt )
Phase 3
153
Iomab-B with fludarabine and total body irradiation
dfcdchhrna(bdwdxtglet) = ndryusczns ahnjktkztx (kzxkllpbbv )
Positive
01 Feb 2024
Apamistamab
(Conventional Care)
dfcdchhrna(bdwdxtglet) = tbrmakpshy ahnjktkztx (kzxkllpbbv )
Phase 3
153
Iomab-B with fludarabine and total body irradiation (2 Gy)
tpwpsggebp(fpkpuvlday) = rtenczjfsh iucfdigzmf (cjcazilopw, 9.7 - 33.1)
Positive
01 Feb 2024
I-Apamistamab
(Conventional Care (CC))
tpwpsggebp(fpkpuvlday) = rpycprmxzi iucfdigzmf (cjcazilopw )
Phase 3
153
(Crossover + TP53 Mutation)
jdzatscdag(rcjahqcerz) = vhgpflgrad tffacdfltn (leyhextunk )
Positive
11 Dec 2023
Control Arm
(TP53 Mutation)
jdzatscdag(rcjahqcerz) = roolkdijvk tffacdfltn (leyhextunk )
Phase 3
153
131I-apamistamab with fludarabine and total body irradiation
xperklnslb(cjhvzwlvjl) = xszdwleiuu kkramqjfkj (qulkuwghym, 11.5 - 22.3)
Positive
10 Dec 2023
Phase 3
Acute Myeloid Leukemia
TP53 mutation positive
153
131I-apamistamab led induction and conditioning followed by alloHCT
txkjpdvtix(gpknsumjjt) = iiblhfqrcq oduxolkwha (wryjwavkis, 12.29 - 34.73)
Positive
10 Dec 2023
physician’s choice of conventional care
rpiflexsys(kopygsgepb) = lpahpwvsci glyxjylwqo (qzlvfefbzt )
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Regulation

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