A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma
NCT ID: NCT06768489
Last Updated: 2026-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
140 participants
INTERVENTIONAL
2024-12-04
2028-11-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Treatment Regimen A and C: JNJ-79635322+Daratumumab
Participants who have received 1-3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (Treatment regimen A1) will receive a dose of JNJ-79635322 along with daratumumab to establish the recommended phase 2 doses (RP2D\[s\]) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Based on the study evaluation team (SET) decision, enrollment may proceed in participants with newly diagnosed multiple myeloma (NDMM) (Treatment regimen A2/C). Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
JNJ-79635322
JNJ-79635322 will be administered subcutaneously.
Daratumumab
Daratumumab will be administered subcutaneously.
Treatment Regimen B: JNJ-79635322+Pomalidomide
Participants who have received greater than or equal to (\>=)1 prior line of therapy, including a PI and lenalidomide, and are lenalidomide refractory or \>=2 prior lines of therapy, including a PI and lenalidomide will receive a dose of JNJ-79635322 along with pomalidomide to establish the RP2D(s) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
JNJ-79635322
JNJ-79635322 will be administered subcutaneously.
Pomalidomide
Pomalidomide will be administered orally.
Treatment Regimen D and E: JNJ-79635322 + Daratumumab + Lenalidomide Combination
Participants with NDMM will receive a dose of JNJ-79635322 along with daratumumab and lenalidomide to establish the RP2D\[s\] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
JNJ-79635322
JNJ-79635322 will be administered subcutaneously.
Daratumumab
Daratumumab will be administered subcutaneously.
Lenalidomide
Lenalidomide will be administered orally.
Interventions
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JNJ-79635322
JNJ-79635322 will be administered subcutaneously.
Daratumumab
Daratumumab will be administered subcutaneously.
Pomalidomide
Pomalidomide will be administered orally.
Lenalidomide
Lenalidomide will be administered orally.
Eligibility Criteria
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Inclusion Criteria
* Meet treatment regimen-specific requirements as follows: Treatment regimen A (JNJ-79635322+daratumumab):Treatment regimen A1: Have been treated with 1 to 3 prior lines of therapy, including a proteasome inhibitor (PI) and an inhibitor, immunomodulatory drug (IMiD) therapy for the treatment of multiple myeloma (MM); Treatment regimen A2: Newly diagnosed MM naïve to multiple myeloma (or other related plasma cell neoplasm)-directed treatments; Treatment regimen B (JNJ-79635322+pomalidomide): Have received greater than or equal to (\>=) 1 prior line of therapy, including a PI and lenalidomide, and are lenalidomide refractory OR \>=2 prior lines of therapy, including a PI and lenalidomide; Treatment Regimens C, D, and E: Newly diagnosed MM naïve to multiple myeloma (or other related plasma cell neoplasm)-directed treatments
* Have a weight \>=40 kilograms
* Must have an Eastern Cooperative Oncology Group status of 0 or 2
* Have measurable disease at screening as defined by at least 1 of the following: a) Serum monoclonal protein (M-protein) level \>= 0.5 gram per deciliter (g/dL); or b) Urine M-protein level \>=200 milligram (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \>= 10 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 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-computed tomography (or whole-body magnetic resonance imaging approved by sponsor), and not previously radiated
Exclusion Criteria
* Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: a) Targeted therapy, epigenetic therapy, monoclonal antibody (mAb) treatment, or treatment with an investigational drug or an invasive investigational medical device within 21 days or 5 half-lives, whichever is less. b) Gene-modified adoptive cell therapy (example, chimeric antigen receptor \[CAR\] modified T cells, natural killer cells) within 90 days. c) Prior anti-CD38 directed therapy within 90 days (for treatment regimen A only; within 21 days for treatment regimen B). d) Conventional chemotherapy within 21 days. e) PI therapy within 14 days. f) Immunomodulatory agent therapy within 7 days. g) Radiotherapy within 14 days
* Stem cell transplantation: a) Allogeneic stem cell transplant within 6 months before the first dose of study treatment. b) Received an autologous stem cell transplant less than or equal to (\<=)12 weeks before the first dose of study treatment
* Nonhematologic toxicity from prior anticancer therapy that has not resolved to baseline level or to grade \<=1 (except alopecia, tissue post-RT fibrosis \[any grade\] or peripheral neuropathy grade \<=3)
* Prior treatment with CD3-redirecting therapy
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Monash Medical Centre
Clayton, , Australia
St Vincents Hospital Melbourne
Fitzroy, , Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
Calvary Mater Newcastle Hospital
Waratah, , Australia
Wollongong Hospital
Wollongong, , Australia
Carmel Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
VU Medisch Centrum
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Hosp. Clinic de Barcelona
Barcelona, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Countries
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Central Contacts
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References
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Pillarisetti K, Yang D, Luistro L, Yao J, Smith M, Vulfson P, Testa J Jr, Ponticiello R, Brodeur SR, Heidrich B, Packman K, Singh S, Attar RM, Elsayed YA, Philippar U. Ramantamig (JNJ-79635322), a novel T-cell-engaging trispecific antibody targeting BCMA, GPRC5D, and CD3, in multiple myeloma models. Blood. 2025 Oct 16:blood.2025030027. doi: 10.1182/blood.2025030027. Online ahead of print.
Other Identifiers
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79635322MMY1002
Identifier Type: OTHER
Identifier Source: secondary_id
2024-515316-44-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
79635322MMY1002
Identifier Type: -
Identifier Source: org_study_id
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