Waldenstrom Macroglobulinemia

9
Pipeline Programs
7
Companies
11
Clinical Trials
4 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
9
0
0
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
467%
Small Molecule
233%
+ 4 programs with unclassified modality

Competitive Landscape

7 companies ranked by most advanced pipeline stage

BeOne Medicines
BeOne MedicinesCA - San Carlos
2 programs
1
SonrotoclaxPhase 21 trial
ZanubrutinibN/ASmall Molecule1 trial
Active Trials
NCT05640102RecruitingEst. Dec 2027
NCT05952037Active Not Recruiting114Est. Aug 2028
GS
Gilead SciencesFOSTER CITY, CA
2 programs
2
EpratuzumabPhase 2Monoclonal Antibody1 trial
EpratuzumabPhase 2Monoclonal Antibody
Active Trials
NCT00113802Terminated31Est. Dec 2006
AbbVie
AbbVieNORTH CHICAGO, IL
2 programs
2
IBRUTINIBPhase 2Small Molecule3 trials
VenetoclaxPhase 21 trial
Active Trials
NCT04273139Active Not Recruiting45Est. Feb 2028
NCT03379428Active Not Recruiting34Est. Jan 2025
NCT02419560Completed37Est. May 2021
+1 more trials
J&
Johnson & JohnsonNEW BRUNSWICK, NJ
1 program
1
Ibrutinib / Bortezomib / RituximabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT03620903Active Not Recruiting53Est. Feb 2027
Cellectar Biosciences
Cellectar BiosciencesFLORHAM PARK, NJ
1 program
1
Iopofosine I 131 single dosePhase 21 trial
Active Trials
NCT02952508Active Not RecruitingEst. Dec 2026
ADC Therapeutics
ADC TherapeuticsNJ - New Providence
1 program
1
Loncastuximab TesirinePhase 21 trial
Active Trials
NCT05190705RecruitingEst. Aug 2028
Pfizer
PfizerNEW YORK, NY
1 program
1
Venetoclax; RituximabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT05099471Recruiting80Est. Mar 2033

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
AbbVieVenetoclax
PfizerVenetoclax; Rituximab
BeOne MedicinesSonrotoclax
ADC TherapeuticsLoncastuximab Tesirine
AbbVieIBRUTINIB
Johnson & JohnsonIbrutinib / Bortezomib / Rituximab
Cellectar BiosciencesIopofosine I 131 single dose
Gilead SciencesEpratuzumab
AbbVieIBRUTINIB
AbbVieIBRUTINIB
BeOne MedicinesZanubrutinib

Clinical Trials (11)

Total enrollment: 408 patients across 11 trials

Study to Assess Change in Disease Activity of Oral Venetoclax in Adult Participants With Recurring Relapsed or Refractory (R/R) Waldenström Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)

Start: Mar 2026Est. completion: Jul 202814 patients
Phase 2Recruiting
NCT05099471PfizerVenetoclax; Rituximab

Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia

Start: Mar 2025Est. completion: Mar 203380 patients
Phase 2Recruiting

A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

Start: Oct 2023Est. completion: Aug 2028114 patients
Phase 2Active Not Recruiting
NCT05190705ADC TherapeuticsLoncastuximab Tesirine

Loncastuximab Tesirine in WM

Start: Feb 2022Est. completion: Aug 2028
Phase 2Recruiting

Ibrutinib + Venetoclax in Untreated WM

Start: Jul 2020Est. completion: Feb 202845 patients
Phase 2Active Not Recruiting
NCT03620903Johnson & JohnsonIbrutinib / Bortezomib / Rituximab

Efficacy of First Line B-RI for Treatment Naive Waldenström's Macroglobulinemia

Start: Sep 2019Est. completion: Feb 202753 patients
Phase 2Active Not Recruiting
NCT02952508Cellectar BiosciencesIopofosine I 131 single dose

Study of Iopofosine I 131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) and Pivotal Expansion in Waldenstrom Macroglobulinemia

Start: Jul 2017Est. completion: Dec 2026
Phase 2Active Not Recruiting

Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia

Start: Aug 2004Est. completion: Dec 200631 patients
Phase 2Terminated

Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer

Start: Nov 2017Est. completion: Jan 202534 patients
Phase 1/2Active Not Recruiting

Optimal Dose Finding Study ABT-199 and Ibrutinib in MCL

Start: Apr 2015Est. completion: May 202137 patients
Phase 1Completed

Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia

Start: Mar 2023Est. completion: Dec 2027
N/ARecruiting

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

4 actively recruiting trials targeting 408 patients
Monoclonal Antibody is the dominant modality (67% of programs)
7 companies competing in this space