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Iopofosine I 131 single dose

Phase 2

Waldenstrom Macroglobulinemia | Small molecule | Oncology |Cellectar Biosciences, Inc.|Last Updated: Mar 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02952508Study of Iopofosine I-131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) With Expansion in WaldenstromPHASE2 ACTIVE NOT_RECRUITING 120Jul 26, 2017Dec 22, 2027Mar 18, 202652 United States, Australia +9
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Study Endpoints
Primary Endpoints
Part A [CLOVER-1] Clinical benefit rate
84 days

Response assessment per International Uniform Response Criteria for Multiple Myeloma; Lugano Criteria for lymphoma; International Workshop on Chronic Lymphocytic Leukemia for CLL; VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment; or 2005 Response Criteria for CNS Lymphoma

Part B [CLOVER-WaM] Major Response Rate
12 months

Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment

Secondary Endpoints
Part A [CLOVER-1] Overall Response Rate
135 days
Part A [CLOVER-1] Progression Free Survival
135 days
Part A [CLOVER-1] Time to Next Treatment
3 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Iopofosine I 131, intravenous administration WMEXPERIMENTALIopofosine I 131 in Waldenstroms Macroglobulinemia
Iopofosine I 131, intravenous administration MMEXPERIMENTALIopofosine I 131 in Multiple Myeloma
Iopofosine I 131, intravenous administration CNS LymphomaEXPERIMENTALIopofosine I 131 in Central Nervous System Lymphoma
Iopofosine I 131 intravenous administration NHL [CLOSED]EXPERIMENTALIopofosine I 131 in Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma
Interventions
NameTypeDescription
Iopofosine I 131 single doseDRUGRadiopharmaceutical
Iopofosine I 131 multiple doseDRUGRadiopharmaceutical
Iopofosine I 131 fractionated doseDRUGRadiopharmaceutical
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites52

\[CLOVER-1\] Inclusion Criteria: All Patients * Histologically or cytologically confirmed MM; Patients with primary or secondary CNSL may be enrolled. * ECOG performance status of 0 to 2 * 18 years of age or older * Life expectancy of at least 6 months * Platelets ≥ 75,000/µL (if full-dose anticoag...

Countries:United StatesAustraliaBrazilCzechiaFinlandFranceGreeceIsraelSpainTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT02952508primaryCompletionDate: changed
LOWMay 24, 2026NCT02952508studyFirstPostDate: changed