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Teclistamab In Waldenstrom's Macroglobulinemia

NCT07791498 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-08-28

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the efficacy of teclistamab in participants with relapsed or refractory Waldenstrom's macroglobulinemia who have received prior therapy. This study also aims to assess the safety and tolerability of teclistamab, how quickly and to what extent response is seen in participants, how strong any clinical benefit of teclistamab might be, and determine the response to teclistamab based on the combination of MY88 and CXCR4 mutations. The main questions it aims to answer are:

* Will teclistamab be effective in treating Waldenstrom's macroglobulinemia?
* By targeting BCMA with teclistamab, will direct Waldenstrom's macroglobulinemia tumor death occur? Participants will receive teclistamab for up to 9 cycles (cycle 1 is 14 days, cycles 2-5 are 28 days, and cycles 6-9 are 56 days) or until their disease progresses, another illness or change in their condition prevents them from further receiving the treatment, they experience unacceptable side effects, they demonstrate an inability or unwillingness to receive the medication regimen, or they decide to withdraw from the study. Participants will be followed for up to 3 years from the last treatment.

Conditions

  • Waldenstrom's Macroglobulinemia

Interventions

DRUG

Teclistamab

Subcutaneous injection into the abdomen received on days 1, 4, and 7 of the first 14-day cycle, then every week for up to four 28-day cycles, and then for up to four 56-day cycles, with a maximum of 9 cycles.

Sponsors & Collaborators

Principal Investigators

  • Andrew Branagan, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-02-19
Primary Completion
2027-09-01
Completion
2029-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07791498 on ClinicalTrials.gov