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| ID | Type | Description | Link |
|---|---|---|---|
| 79635322MMY1002 | Other Identifier | Janssen Research & Development, LLC | |
| 2024-515316-44-00 | Registry Identifier | EUCT number |
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The primary purpose of this study for Part 1 (Dose Escalation) is to identify the safe effective dose (recommended Phase 2 doses [RP2Ds]) and schedule for JNJ-79635322 treatment regimen in combination with daratumumab with or without lenalidomide or with pomalidomide; and for Part 2 (Dose Expansion) is to further characterize the safety and tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Regimen A and C: JNJ-79635322+Daratumumab | Experimental | Participants who have received 1-3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) (Treatment regimen A1 and A3) will receive 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 regimens A2, A4 and 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. |
|
| Treatment Regimen B: JNJ-79635322+Pomalidomide | Experimental | 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 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. |
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| Treatment Regimen D and E: JNJ-79635322 + Daratumumab + Lenalidomide Combination | Experimental | Participants with NDMM will receive 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-79635322 | Drug | JNJ-79635322 will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants with Dose-limiting Toxicity (DLT) | DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. | Up to 28 days |
| Number of Participants with Adverse Events (AEs) by Severity | An AE 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. | Up to 3 Years and 3 months |
| Number of Participants with Clinically Significant Laboratory Abnormalities | Participants with clinically significant laboratory abnormalities (hematology and chemistry) will be reported. | Up to 3 Years and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Response Rate | Overall response rate is defined as percentage of participants who have a partial response (PR) or better evaluated by the investigator as per international myeloma working group (IMWG) 2016 criteria. | Up to 3 Years and 3 months |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash Medical Centre | Recruiting | Clayton | 3168 | Australia | ||
| St Vincents Hospital Melbourne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41100731 | Derived | Pillarisetti K, Yang D, Luistro L, Yao J, Smith M, Vulfson P, Testa JS, Ponticiello R, Brodeur S, Heidrich B, Packman K, Singh S, Attar R, Elsayed Y, Philippar U. Ramantamig (JNJ-79635322), a novel T-cell-engaging trispecific antibody targeting BCMA, GPRC5D, and CD3, in multiple myeloma models. Blood. 2026 Feb 19;147(8):834-847. doi: 10.1182/blood.2025030027. |
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The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/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
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|
| Daratumumab | Drug | Daratumumab will be administered subcutaneously. |
|
| Pomalidomide | Drug | Pomalidomide will be administered orally. |
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| Lenalidomide | Drug | Lenalidomide will be administered orally. |
|
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), as per IMWG 2016 response criteria, or death due to progression, whichever occurs first. |
| Up to 3 Years and 3 months |
| Time to Response (TTR) | TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better as defined by IMWG 2016 response criteria. | Up to 3 Years and 3 months |
| Serum Concentration of JNJ-79635322 and Daratumumab | Serum samples will be analyzed to determine concentrations of JNJ-79635322 and daratumumab. | Up to 3 Years and 3 months |
| Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUCinf) for JNJ-79635322 and Daratumumab | AUCinf for JNJ-79635322 and daratumumab will be reported. | Up to 3 Years and 3 months |
| Area Under the Serum Concentration Time Curve from Time Zero to the Last Measurable Concentration [AUC(0-t)] for JNJ-79635322 and Daratumumab | AUC(0-t) for JNJ-79635322 and daratumumab will be reported. | Up to 3 Years and 3 months |
| Area Under the Serum Concentration Time Curve During the Dosing Interval (AUCtau) for JNJ-79635322 and Daratumumab | AUCtau for JNJ-79635322 and daratumumab will be reported. | Up to 3 Years and 3 months |
| Maximum Serum Concentration (Cmax) for JNJ-79635322 and Daratumumab | Cmax for JNJ-79635322 and daratumumab will be reported. | Up to 3 Years and 3 months |
| Half Life (T1/2) for JNJ-79635322 and Daratumumab | T1/2 for JNJ-79635322 and daratumumab will be reported. | Up to 3 Years and 3 months |
| Time to Reach Cmax (Tmax) for JNJ-79635322 and Daratumumab | Tmax for JNJ-79635322 and daratumumab will be reported. | Up to 3 Years and 3 months |
| Systemic Clearance (CL/F) for JNJ-79635322 and Daratumumab | CL/F for JNJ-79635322 and daratumumab will be reported. | Up to 3 Years and 3 months |
| Apparent Volume of Distribution at Steady State (Vss/F) for JNJ-79635322 and Daratumumab | Vss/F for JNJ-79635322 and daratumumab will be reported. | Up to 3 Years and 3 months |
| Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322 and Daratumumab | Participants with anti-drug antibodies to JNJ-79635322 and daratumumab will be reported. | Up to 3 Years and 3 months |
| Recruiting |
| Fitzroy |
| 3065 |
| Australia |
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | 3000 | Australia |
| Calvary Mater Newcastle Hospital | Recruiting | Waratah | 2298 | Australia |
| Wollongong Hospital | Recruiting | Wollongong | 2500 | Australia |
| Carmel Medical Center | Recruiting | Haifa | 3436212 | Israel |
| Hadassah Medical Center | Recruiting | Jerusalem | 9112001 | Israel |
| Sheba Medical Center | Recruiting | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 64239 | Israel |
| VU Medisch Centrum | Recruiting | Amsterdam | 1081 HV | Netherlands |
| Universitair Medisch Centrum Groningen | Recruiting | Groningen | 9713 GZ | Netherlands |
| UMC Utrecht | Recruiting | Utrecht | 3584 CX | Netherlands |
| Hosp. Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hosp Clinico Univ de Salamanca | Recruiting | Salamanca | 37007 | Spain |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C556306 | daratumumab |
| C467566 | pomalidomide |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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