Linvoseltamab
DrugAdministered per the protocol
Other names: REGN5458, Lynozyfic™
NCT Number: NCT05137054
This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again.
In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies).
This study is the first time linvoseltamab will be combined with other cancer therapies.
The main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination.
The study is looking at several other research questions, including:
* How many participants treated with linvoseltamab in combination with each of the other cancer treatments have improvement of their multiple myeloma * What side effects may happen from taking linvoseltamab together with another cancer treatment * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Centre Hospitalier Universitaire (CHU) de Poitiers, Poitiers, New Aquitaine, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
General Key Inclusion Criteria:
Cohort Specific Inclusion Criteria:
For cohorts 1-6, each participant must have RRMM with progression following at least 3 lines of therapy, or at least 2 lines of therapy and either prior exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory imide drug (IMiD) and 1 Proteasome Inhibitor (PI), or double-refractory to 1 PI and 1 IMiD, or the combination of 1 PI and 1 IMiD Cohort 1: Prior treatment with daratumumab is allowed if previously tolerated, as described in the protocol Cohort 2: Prior treatment with carfilzomib is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 3: Prior treatment with lenalidomide is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 4: Prior treatment with bortezomib is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 5: Prior treatment with pomalidomide is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 6: Prior treatment with isatuximab is allowed if previously tolerated, as described in the protocol
Cohort 7 and 8:
General Key Exclusion Criteria:
Cohort Specific Exclusion Criteria:
Cohort 2: Dose expansion: Prior treatment with a BCMA-directed CAR T-cell therapy will not be exclusionary if completed at least 12 weeks prior to first study treatment Cohort 3: Known malabsorption syndrome or pre-existing gastrointestinal (GI) condition that may impair absorption of lenalidomide; delivery of lenalidomide via nasogastric tube or gastrostomy tube is not allowed Cohort 4: Peripheral neuropathy grade ≥2 Cohort 5: Known malabsorption syndrome or pre-existing GI conditions that may impair absorption of pomalidomide; delivery of pomalidomide via nasogastric tube or gastrostomy tube is not allowed
Cohort 7:
Cohort 8:
Cohort 9:
Cohort 10:
Dose finding portion: Prior treatment with any BCMA-directed immunotherapy will not be exclusionary, as described in the protocol Dose expansion portion: Prior treatment with any T cell-engaging bispecific antibody directed against BCMA will be exclusionary, as described in the protocol
NOTE: Other protocol defined inclusion/exclusion criteria apply
Administered per the protocol
Other names: REGN5458, Lynozyfic™
Administered per the protocol
Other names: Darzalex®; Darzalex Faspro™
Administered per the protocol
Other names: Kyprolis®
Administered per the protocol
Other names: Revlimid®
Administered per the protocol
Other names: Velcade®
Administered per the protocol
Other names: Imnovid, Pomalyst®
Administered per the protocol
Other names: Sarclisa®
Administered per the protocol
Other names: REGN3767
Administered per the protocol
Other names: LIBTAYO, REGN2810
Administered per the protocol
Other names: PF-03084014
Administered per the protocol
Other names: BFCR4350A, RO7187797
Time frame: Up to 28 Days
Dose finding portion only
Time frame: Up to 5 Years
Time frame: Up to 5 Years
Time frame: Up to 5 Years
Time frame: Up to 5 Years
Time frame: Up to 5 Years
Time frame: Up to 5 Years
Time frame: Up to 5 Years
≥ grade 3 per National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE v5.0]
Time frame: Up to 5 Years
Time frame: Up to 5 Years
Time frame: Up to 5 Years
Time frame: Up to 5 Years
Time frame: Up to 5 Years
Time frame: Up to 5 Years
Time frame: Up to 5 Years
Contact information is provided by the study sponsor or research team.
Regeneron Pharmaceuticals
Industry
Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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