A Phase 1/2 Study of Linvoseltamab in Patients with Relapsed or Refractory Systemic Light Chain Amyloidosis

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objective:

Dose Escalation - Phase 1

To assess the safety, tolerability, and to determine the RP2DRs of linvoseltamab in participants with relapsed or refractory AL amyloidosis.

Dose Expansion - Phase 2 (Secondary for Phase 1)

To evaluate the effect of linvoseltamab on hematologic CR in participants with relapsed or refractory AL amyloidosis.

Secondary Objective: Phases 1 and 2

To evaluate the effect of linvoseltamab on hematologic VGPR or better response.
To evaluate the effect of linvoseltamab on overall hematologic response.
To evaluate the effect of linvoseltamab on the timing of hematologic Response.
To evaluate the effect of linvoseltamab on the duration of hematologic response.
To evaluate the effect of linvoseltamab on hematologic PFS.
To evaluate the safety of linvoseltamab.
Phase 2 only: To compare the efficacy between the 2 RP2DRs that are expected to be linvoseltamab 80 mg SC and 240 mg SC.
Phase 2 only: To compare the safety between the 2 RP2DRs that are expected to be linvoseltamab 80 mg SC and 240 mg SC.
To evaluate the impact of linvoseltamab on major organ deterioration and/or death.
To evaluate the impact of linvoseltamab on OS.
To evaluate the effect of linvoseltamab on induction of a clinically meaningful renal response in participants with baseline renal involvement.
To evaluate the effect of linvoseltamab on induction of a clinically meaningful cardiac response in participants with baseline cardiac involvement.
To evaluate the timing of renal response to linvoseltamab in participants with baseline renal involvement.
To evaluate the timing of cardiac response to linvoseltamab in participants with baseline cardiac involvement.
To evaluate the PK of linvoseltamab.
To assess the immunogenicity of linvoseltamab.

Eligibility

Inclusion Criteria:

Confirmed diagnosis of AL amyloidosis, as described in the protocol
Measurable disease as defined by serum difference between involved and uninvolved free light chains (dFLC) concentration, as described in the protocol
Previously treated after at least 1 prior therapy and requiring further treatment as assessed by the Investigator
N-terminal pro b-type natriuretic peptide (NT-proBNP) ≤8500 ng/L during screening
Adequate hepatic, hematologic, renal, and cardiac function, as described in the protocol
Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening

Exclusion Criteria:

History of other non-AL amyloidosis
Greater than 60% plasmacytosis on a bone marrow biopsy and/or aspirate during screening
Presence of lytic bone lesion(s) or extramedullary plasmacytoma on imaging during screening
Myocardial infarction within the past 6 months prior to the first screening visit
Known active infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first administration of study drug

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices