A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma

• ClinicalTrials.gov Identifier: NCT05652335
• Recruitment Status: Recruiting
• First Posted: December 15, 2022
• Last Update Posted: May 31, 2023
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

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) in Part 2 (dose expansion).

Condition or disease	Intervention/treatment	Phase
Relapsed or Refractory Multiple Myeloma	Drug: JNJ-79635322	Phase 1

Detailed Description:

The study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-79635322 administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as the last study assessment for the last participant on study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
• Actual Study Start Date: November 22, 2022
• Estimated Primary Completion Date: April 18, 2025
• Estimated Study Completion Date: May 2, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: JNJ-79635322; JNJ-79635322 will be administered as SC injection.
Experimental: Part 2: Dose Expansion; Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.	Drug: JNJ-79635322; JNJ-79635322 will be administered as SC injection.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. Serum Concentration of JNJ-79635322 [ Time Frame: Up to 2 Years 5 months ]
   Serum samples will be analyzed to determine concentrations of JNJ-79635322.
2. Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322 [ Time Frame: Up to 2 Years 5 months ]
   Number of participants with presence of anti-drug antibodies to JNJ-79635322 will be reported.
3. Preliminary Anticancer Activity of JNJ-79635322 [ Time Frame: Up to 2 Years 5 months ]
   Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.
4. Time to Response (TTR) [ Time Frame: Up to 2 Years 5 months ]
   TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for PR or better as defined by IMWG 2016 response criteria.
5. Duration of Response (DOR) [ Time Frame: Up to 2 Years 5 months ]
   DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG 2016 response criteria, or death due to any cause, whichever occurs first.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
• Have relapsed or refractory disease and have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM)
• 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 plasmacytomas (>=2 centimeter [cm])

Exclusion Criteria:

• 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 within 21 days 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, or CD3-redirecting therapy within 21 days)
• 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, etc)

Contacts and Locations

Contacts

Contact: Study Contact; 844-434-4210; Participate-In-This-Study@its.jnj.com

Locations

Belgium

UZ Antwerpen; Recruiting

Edegem, Belgium, 2650

UZ Gent; Recruiting

Gent, Belgium, 9000

CHU de Liège; Recruiting

Liege, Belgium, 4000

France

CHU Nantes; Recruiting

Nantes, France, 44093

CHU Lyon Sud; Recruiting

Pierre benite, France, 69495

Chu Rennes - Hopital Pontchaillou; Recruiting

Rennes, France, 35000

Institut Claudius Regaud; Recruiting

Toulouse, France, 31100

Netherlands

VUMC Amsterdam; Recruiting

Amsterdam, Netherlands, 1081 HV

Spain

Hosp. Univ. Germans Trias I Pujol; Recruiting

Badalona, Spain, 08916

Hosp. Clinic I Provincial de Barcelona; Recruiting

Barcelona, Spain, 08036

Hosp. Univ. Fund. Jimenez Diaz; Recruiting

Madrid, Spain, 28040

Clinica Univ. de Navarra; Recruiting

Pamplona, Spain, 31008

Hosp. Clinico Univ. de Salamanca; Recruiting

Salamanca, Spain, 37007

United Kingdom

University College Hospital; Recruiting

London, United Kingdom, W1T 7HA

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

More Information

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT05652335
• Other Study ID Numbers: CR109234; 2022-001465-12 ( EudraCT Number ); 79635322MMY1001 ( Other Identifier: Janssen Research & Development, LLC )
• First Posted: December 15, 2022
• Last Update Posted: May 31, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
• URL: https://www.janssen.com/clinical-trials/transparency

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases