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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05652335
Recruitment Status : Recruiting
First Posted : December 15, 2022
Last Update Posted : May 31, 2023
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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.

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.

Information from the National Library of Medicine

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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05652335

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

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UZ Antwerpen Recruiting
Edegem, Belgium, 2650
UZ Gent Recruiting
Gent, Belgium, 9000
CHU de Liège Recruiting
Liege, Belgium, 4000
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
VUMC Amsterdam Recruiting
Amsterdam, Netherlands, 1081 HV
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
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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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    Key Record Dates
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases