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| ID | Type | Description | Link |
|---|---|---|---|
| 79635322MMY1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2022-001465-12 | EudraCT Number | ||
| 2023-503679-12-00 | Registry Identifier | EUCT number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. |
|
| Part 2: Dose Expansion | Experimental | Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-79635322 | Drug | JNJ-79635322 will be administered as SC injection. |
|
| 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 2 years 5 months |
| Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity | 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. | Up to 2 years 5 months |
| Part 2: Number of Participants with Abnormalities in Laboratory Values | Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported. | Up to 2 Years 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of JNJ-79635322 | Serum samples will be analyzed to determine concentrations of JNJ-79635322. | Up to 2 Years 5 months |
| Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322 |
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Inclusion Criteria:
For participants with relapsed or refractory multiple myeloma:
For participants with previously treated AL amyloidosis:
Exclusion Criteria:
For participants with relapsed or refractory multiple myeloma:
For participants with previously treated AL amyloidosis:
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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 |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States | |
| City of Hope Orange County Lennar Foundation Cancer Center |
| 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 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
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Number of participants with presence of anti-drug antibodies to JNJ-79635322 will be reported.
| Up to 2 Years 5 months |
| Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Myeloma Working Group (IMWG) 2016 Response Criteria | Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria. | Up to 2 Years 5 months |
| Time to Response (TTR) as Defined by IMWG 2016 Response Criteria | 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 partial response (PR) or better as defined by IMWG 2016 response criteria. | Up to 2 Years 5 months |
| Duration of Response (DOR) as Defined by IMWG 2016 Response Criteria | 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. | Up to 2 Years 5 months |
| Part 2: Time to Response (TTR) as Defined by International Amyloidosis Consensus Criteria | 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 International Amyloidosis Consensus Criteria. | Up to 2 Years 5 months |
| Part 2: Duration of Response (DOR) as Defined by International Amyloidosis Consensus Criteria | 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 International Amyloidosis Consensus Criteria or death due to any cause, whichever occurs first. | Up to 2 Years 5 months |
| Part 2: Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Amyloidosis Consensus Criteria | Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Amyloidosis Consensus Criteria. | Up to 2 Years 5 months |
| Recruiting |
| Irvine |
| California |
| 92618 |
| United States |
| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States |
| Colorado Blood Cancer Institute | Recruiting | Denver | Colorado | 80218 | United States |
| Icahn School of Medicine at Mt. Sinai | Recruiting | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28001 | United States |
| University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| UZ Antwerpen | Recruiting | Edegem | 2650 | Belgium |
| UZ Gent | Recruiting | Ghent | 9000 | Belgium |
| CHU de Liege | Recruiting | Liège | 4000 | Belgium |
| CHU Nantes | Recruiting | Nantes | 44093 | France |
| CHU Lyon Sud | Recruiting | Pierre-Bénite | 69495 | France |
| Chu Rennes Hopital Pontchaillou | Completed | Rennes | 35000 | France |
| Institut Claudius Regaud | Recruiting | Toulouse | 31100 | France |
| Japanese Red Cross Medical Center | Recruiting | Shibuya City | 150-8935 | Japan |
| Osaka University Hospital | Recruiting | Suita-shi | 565-0871 | Japan |
| The Cancer Institute Hospital of JFCR | Completed | Tokyo | 135-8550 | Japan |
| VUMC Amsterdam | Recruiting | Amsterdam | 1081 HV | Netherlands |
| Universitair Medisch Centrum Groningen | Recruiting | Groningen | 9713 GZ | Netherlands |
| UMC Utrecht | Recruiting | Utrecht | 3584 CX | Netherlands |
| Hosp. Univ. Germans Trias I Pujol | Recruiting | Badalona | 08916 | Spain |
| Hosp Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hosp Univ Fund Jimenez Diaz | Recruiting | Madrid | 28040 | Spain |
| Clinica Univ. de Navarra | Recruiting | Pamplona | 31008 | Spain |
| Hosp Clinico Univ de Salamanca | Recruiting | Salamanca | 37007 | Spain |
| University College Hospital | Recruiting | London | W1T 7HA | United Kingdom |
| Royal Marsden Hospital | Recruiting | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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