NCT07791498 Teclistamab Waldenstrom's macroglobulinaemia refractory Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07791498 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 1 September 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07791498 is a hot trial to watch
Waldenstrom's macroglobulinaemia refractory is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07791498 is notable because it evaluates Teclistamab in a Phase 2 design sponsored by The Massachusetts General Hospital. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07791498 |
| Official title | Teclistamab In Waldenstrom's Macroglobulinemia |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Teclistamab |
| Sponsor | The Massachusetts General Hospital |
| Geography | United States |
| Enrollment | 24 |
| Primary endpoint | Overall Immunoglobulin M Response in Relapsed or Refractory Participants with Waldenstrom's Macroglobulinemia |
| Endpoint time frame | Day 1 of cycle 1 to first documentation of ORR, PR or better up to 3 years from the last treatment date. |
| Primary completion / readout proxy | Not reported |
Protocol design and endpoint interpretation
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 trea
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 24 participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Overall Immunoglobulin M Response in Relapsed or Refractory Participants with Waldenstrom's Macroglobulinemia (Day 1 of cycle 1 to first documentation of ORR, PR or better up to 3 years from the last treatment date.) — Overall immunoglobulin M (IgM) efficacy will be evaluated by assessing the IgM response rate and the objective response rate (ORR, PR or better; at least 25% improvement in IgM from baseline). Overall response rate (ORR) includes patients who achieved minor response (MR), partial response (PR), very good partial response (VGPR), and complete response (CR). Response rates will be presented with exact 95% confidence in
Readout outlook and evidence gap
The current protocol points to Not reported as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Teclistamab is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: The Massachusetts General Hospital is resolved to a normalized organization record in SUFFOLK COUNTY, United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07791498 provides a focused lens on Waldenstrom's macroglobulinaemia refractory development. Its value will be determined by whether Teclistamab can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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