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Clinical Trials in the UK / NCT03761108
Recruiting Phase 1/2

Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

NCT03761108 · tracked via the Priya Life Science UK tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 1/2
Started
2019-01-23
Last updated
2026-04-20

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Linvoseltamab

Linvoseltamab: Administered per the protocol

Study summary

The main purpose of this study is to learn about the safety of linvoseltamab and to find out what is the best dose of linvoseltamab to give to patients with multiple myeloma and to look for any signs that linvoseltamab can effectively treat cancer.

The study is looking at several other research questions, including:

* Side effects that may be experienced by people receiving linvoseltamab
* How linvoseltamab works in the body
* How much linvoseltamab is present in the blood
* How linvoseltamab may work to treat cancer

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 2. Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria 3. Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria as defined in the protocol. * Phase 1, Part 1 (Dose Escalation): Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease or intolerance of the therapy and including either: a. Progression on or after at least 3 lines of therapy, or intolerance of therapy, including a proteasome inhibitor, an Immunomodulatory agent (IMiD), and an anti-CD38 antibody, OR b. Progression on or after an anti-CD38 antibody and have disease that is "double refractory" to a proteasome inhibitor and an IMiD, or intolerance of therapy. The anti-CD38 antibody may have been administered alone or in combination with another agent such as a proteasome inhibitor (PI). Refractory disease is defined as lack of response or relapse within 60 days of last treatment. * Phase 1, Part 2 (SC Administration): Patients with MM whose disease meets the following criteria: a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b. Patients must be triple-refractory, defined as being refractory to prior treatment with at least 1 anti-CD38 antibody, a proteasome inhibitor, and an IMiD. * Phase 2 (Cohorts 1 and 2): Patients with MM whose disease meets the following criteria: a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b. Patients must be triple- refractory, defined as being refractory\* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody. * Phase 2 (Cohort 3): Patients with MM whose disease meets the following criteria: 1. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR 2. Patients must be triple- refractory, defined as being refractory\* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody. * Refractory disease is defined as progression during treatment or within 60 days after completion of therapy, or \<25% response to therapy. AND, for ALL patients, if they have relapsed after a BCMA-directed CAR-T cellular therapy then: • Treatment with a CAR-T must have been associated with a response of PR or better, and • If CAR-T cellular therapy was the most recent prior therapy, excluding corticosteroids, then treatment must have been a minimum of 60 days prior to treatment with linvoseltamab. Key Exclusion Criteria: 1\. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 2. Patients with known MM brain lesions or meningeal involvement 3. Cardiac ejection fraction \<40% by echocardiogram or multi-gated acquisition scan (MUGA) 4. Prior treatment with BCMA-directed immunotherapies, including BCMA bispecific antibodies and BiTEs. Note: BCMA antibody-drug conjugates are not excluded and BCMA-directed CAR-T treatment is not excluded in Phase 2 Cohort 3. 5\. History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment Note: Other protocol defined inclusion / exclusion criteria apply

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
Sylvester Comprehensive Cancer Center Miami Florida Active Not Recruiting
Moffitt Cancer Center - McKinley Drive Tampa Florida Recruiting
Emory University Hospital Atlanta Georgia Recruiting
Indiana University_Michigan Street Indianapolis Indiana Active Not Recruiting
Norton Cancer Institute Louisville Kentucky Recruiting
C. S. Mott_University of Michigan Ann Arbor Michigan Active Not Recruiting
Barbara Ann Karmanos Cancer Center Detroit Michigan Active Not Recruiting
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey Active Not Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
Columbia University Medical Center New York New York Active Not Recruiting
Ohio State University James Cancer Hospital Columbus Ohio Recruiting
Oregon Health and Science University (OHSU) Marquam Hill Campus Portland Oregon Recruiting
University of Texas MD Anderson Clinic Houston Texas Active Not Recruiting
Swedish Cancer Institute Seattle Washington Recruiting
ZNA Psychiatrisch Ziekenhuis Stuivenberg Antwerp Belgium Recruiting
Cliniques Universitaires Saint-Luc Brussels Belgium Recruiting
Universitatsklinikum Essen Essen North Rhine-Westphalia Completed
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR Mainz Rhineland-Palatinate Completed
Universitatsklinikum Wurzburg Würzburg Germany Completed
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital Nagoya Aichi-ken Completed
Nagoya City University Hospital Nagoya Aichi-ken Recruiting
National Cancer Center Hospital East Kashiwa-shi Chiba Recruiting
Gunma University Hospital Maebashi Gunma Recruiting
Ibaraki Prefectural Central Hospital Kasama-shi Ibaraki Recruiting
University Hospital Kyoto Prefectural Univ of Medicine Kyoto Kyoto Recruiting
Saitama Medical University International Medical Center Hidaka Saitama Completed
Tokushima Prefectural Central Hospital Tokushima Tokushima Recruiting
Japanese Red Cross Medical Center Shibuya-ku Tokyo Completed
Keio University Hospital Tokyo Japan Recruiting
National Cancer Center Korea Goyang South Korea Recruiting
Seoul National University Cancer Hospital Seoul South Korea Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital Seoul South Korea Recruiting
Yonsei University College of Medicine, Severance Hospital Seoul South Korea Recruiting
Hospital de la Santa Creu i Sant Pau Barcelona Catalonia Recruiting
Clinica Universidad de Navarra Pamplona Navarre Recruiting
Universitary Hospital La Princesa Madrid Salamanca Recruiting
Hospital Universitario Ramon y Cajal Madrid Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Hospital Clinico Universitario de Salamanca Salamanca Spain Recruiting
Royal Marsden Hospital Sutton Surrey Withdrawn

More Regeneron Pharmaceuticals trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03761108 on ClinicalTrials.gov ↗ ← All trials in the UK