Teclistamab In Waldenstrom's Macroglobulinemia

Conditions

• Waldenstrom's Macroglobulinemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Teclistamab — DRUG
  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.

Study Details

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.

Key Dates

First listed

Aug 28, 2026

Start date

Feb 19, 2027

Status verified

Aug 2026

Primary completion

Sep 1, 2027

Completion

Sep 1, 2029

Study Design

Enrollment

24 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Teclistamab
  Participants with relapsed or refractory Waldenstrom's macroglobulinemia will receive teclistamab. Teclistamab will be administered at the pre-determined dose on days 1, 4, and 7 of the first 14-day cycle via subcutaneous injection into their abdomen. Then, participants will be given teclistamab once every week for up to four 28-day cycles, and then for up to four 56-day cycles, with a maximum of 9 cycles.

Primary Outcome Measure

Overall Immunoglobulin M Response in Relapsed or Refractory Participants with Waldenstrom's Macroglobulinemia [ Time Frame: Day 1 of cycle 1 to first documentation of ORR, PR or better up to 3 years from the last treatment date. ]

Central Contacts

• Andrew Branangan, MD, PhD
  617-724-4000
  [email protected]

Locations (2)

Find similar trials in Boston, MA