Clinical Trials/NCT05652335

NCT05652335

Recruiting

Phase 1

Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated AL Amyloidosis

Janssen Research & Development, LLC53 sites in 7 countries180 target enrollmentNovember 22, 2022

ConditionsRelapsed or Refractory Multiple Myeloma Previously Treated Amyloid Light-chain (AL) Amyloidosis

InterventionsJNJ-79635322

DrugsJNJ-79635322

Overview

Phase: Phase 1
Intervention: JNJ-79635322
Conditions: Relapsed or Refractory Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
Enrollment: 180
Locations: 53
Primary Endpoint: Part 2: Number of Participants with Abnormalities in Laboratory Values
Status: Recruiting
Last Updated: 19 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).

Registry

clinicaltrials.gov

Start Date

November 22, 2022

End Date

August 7, 2028

Last Updated

19 days ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Janssen Research & Development, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•For participants with relapsed or refractory multiple myeloma:
•Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
•Part 1: Have relapsed or refractory disease, have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM),and should have been treated with at least 3 prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, and an anti-CD38-based therapy regardless of prior lines of therapy, Part 2: Have relapsed or refractory disease, have been treated with a PI, IMiD and an anti-CD38 based therapy
•Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
•Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL); or b) Urine M-protein level \>=200 milligrams (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \>=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio; d) For participants without measurable disease in the serum, urine, or involved FLC, presence of 1 or more focus of extramedullary disease (EMD) which meets the following criteria: extramedullary plasmacytoma not contiguous with a bone lesion, at least 1 lesion \>=2 centimeter \[cm\] (at its greatest dimension) diameter on whole body Positron Emission Tomography and Computed Tomography (PET-CT) Scans (or whole body magnetic resonance imaging \[MRI\] approved by sponsor), and not previously radiated (Part 2C participants are not required to have measurable disease)
•For participants with previously treated AL amyloidosis:
•Initial histopathological diagnosis of amyloidosis
•Participant who is not a candidate for available AL amyloidosis therapy with established clinical benefit and should have received at least 3 cycles of 1 prior line of therapy or a total of at least 2 cycles of 2 or more prior lines of therapy for AL amyloidosis
•Measurable disease at screening defined by at least 1 of the following: serum involved free light chain (iFLC) \>=50 mg/L or difference between involved and uninvolved free light chains (dFLC) \>=50 mg/L, or serum m-protein \>= 0.5 g/dL
•One or more organs impacted by systemic AL amyloidosis

Exclusion Criteria

•For participants with relapsed or refractory multiple myeloma:
•Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
•Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
•Received a cumulative dose of corticosteroids equivalent to greater than (\>) 140 mg of prednisone within the 14-day period before the start of study treatment administration
•Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: (proteasome inhibitor \[PI\] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days \[not applicable for Part 2C participants\], or CD3-redirecting therapy within 21 days\[not applicable for Part 2B or 2C participants\])
•Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
•Live, attenuated vaccine within 4 weeks before the first dose of study treatment
•Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (\<=) 1 (except alopecia, tissue post-RT fibrosis \[any grade\] or peripheral neuropathy to Grade \<=3)
•The following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, autoimmune disease, serious active viral or bacterial infection, uncontrolled systemic fungal infection, cardiac conditions (myocardial infarction \<=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, et cetera)
•Part 2C: have progressive disease or refractory disease per IMWG after CAR-T administration

Arms & Interventions

Part 1: Dose Escalation

Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.

Intervention: JNJ-79635322

Part 2: Dose Expansion

Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.

Intervention: JNJ-79635322

Outcomes

Primary Outcomes

Part 2: Number of Participants with Abnormalities in Laboratory Values

Time Frame: Up to 2 Years 5 months

Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.

Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity

Time Frame: Up to 2 years 5 months

An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.

Part 1: Number of Participants with Dose-limiting Toxicity (DLT)

Time Frame: Up to 2 years 5 months

DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

Secondary Outcomes

Duration of Response (DOR) as Defined by IMWG 2016 Response Criteria(Up to 2 Years 5 months)
Part 2: Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Amyloidosis Consensus Criteria(Up to 2 Years 5 months)
Serum Concentration of JNJ-79635322(Up to 2 Years 5 months)
Time to Response (TTR) as Defined by IMWG 2016 Response Criteria(Up to 2 Years 5 months)
Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322(Up to 2 Years 5 months)
Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Myeloma Working Group (IMWG) 2016 Response Criteria(Up to 2 Years 5 months)
Part 2: Duration of Response (DOR) as Defined by International Amyloidosis Consensus Criteria(Up to 2 Years 5 months)
Part 2: Time to Response (TTR) as Defined by International Amyloidosis Consensus Criteria(Up to 2 Years 5 months)