A Ph1/2 Study of Linvoseltamab in Pts with Relapsed/Refractory AL Amyloidosis
Research type
Research Study
Full title
A PHASE 1/2 STUDY OF LINVOSELTAMAB IN PATIENTS WITH RELAPSED OR REFRACTORY SYSTEMIC LIGHT CHAIN AMYLOIDOSIS
IRAS ID
1009644
Contact name
Hui Wang
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Research summary
Linvoseltamab is an antibody-based drug which binds to abnormal cells in the body and triggers the body's immune system to remove those abnormal cells. This study looks to see the safety and efficacy of linvoseltamab, for the treatment of AL amyloidosis.
The study consists of 2 phases (Phase 1 [P1] and Phase 2 [P2]) and participants will be told which part they will be participating in. P1 will study the side effects and determine the recommended doses to be given to pts in P2. P2 will continue to assess the side effects and efficacy of linvoseltamab.
220 participants will participate worldwide for up to 7 years (2 treatment years, 5 follow-up years).
Following informed consent, participants will undergo screening procedures lasting up to 28 days.
During treatment, participants will receive increasing doses (5mg, then 25mg) for the first 2 to 3 weeks via intravenous infusion (through a vein) before getting the full dose (80 or 240 mg). The full dose will be given under the skin (subcutaneous) via injection. Sarilumab may be given before the highest dose of linvoseltamab to determine tolerability. Sarilumab (among other drugs) may help reduce the chance of developing reactions to the drug. Participants will have weekly full doses of linvoseltamab during 4-week cycles, for 12-24 cycles. Time in clinic is determined by the doctor depending on participants response to drug.
Participants return to the clinic 30 days after their last dose for an end-of-treatment visit. They return to the clinic approximately 60 and 90 days after their last dose, then every 8 weeks (for up to 1 year) and then every 12 weeks (beginning 1 year after their last dose for 4 years) for monitoring.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0087
Date of REC Opinion
1 Jul 2024
REC opinion
Further Information Favourable Opinion