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| ID | Type | Description | Link |
|---|---|---|---|
| 87801493LYM1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-505165-93-00 | Registry Identifier | EUCT number |
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The purpose of this study is to characterize safety and to determine the recommended phase 2 regimen (RP2R) for JNJ-87801493 in combination with T-cell engagers (TCEs) [Part A: Dose Escalation] and to further assess the safety of JNJ-87801493 at the RP2R in combination with TCEs [Part B: Dose Expansion].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose escalation | Experimental | Participants will receive one cycle of TCE monotherapy (step up dosing) with either JNJ-80948543 or JNJ-75348780 followed by initiation of combination therapy with JNJ-87801493 at least one week later. |
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| Part 2:Dose expansion | Experimental | Participants with specific B-cell NHL histologies will receive recommended phase 2 regimen (RP2R) of JNJ-87801493 with TCE as determined in Part 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-87801493 | Drug | JNJ-87801493 will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) | Number of participants with DLTs will be reported. The DLTs are drug-related toxicities and are defined as any of the following: fatal toxicity, high grade non-hematologic toxicity, or hematologic toxicity | Up to 2 years 7 months |
| Part 1 and 2: Percentage of Participants with Adverse Events (AEs) by Severity | An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity for AEs will be specified as per: NCI-CTCAE grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and; American Society for Transplantation and Cellular Therapy (ASTCT) guidelines which is Grade 5 (death related to adverse event); Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events [ICANS]). | Up to 2 years 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780 | Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. | Up to 2 years 7 months |
| Area Under the Curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin Hospital | Heidelberg | 3084 | Australia | |||
| The Alfred Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41742895 | Derived | Kuchnio A, Yang D, Vloemans N, Cornelissen I, Amorim R, Perova T, Lowenstein C, Janssen L, Suls T, Bekkers M, Lasorsa E, Fontan L, Nemani N, Hojnacki T, Han C, Sukumaran S, Medeiros N, Srinivasan S, Wu B, Chen J, Feldkamp MD, Wu S, Habte H, McRee AJ, Daskalakis N, Krayer J, Holland C, Attar R, DeYoung PM, Singh S, Elsayed Y, Philippar U. Characterization of JNJ-80948543 a novel CD79bxCD20xCD3 trispecific antibody for B-cell non-Hodgkin lymphoma. Haematologica. 2026 Feb 26. doi: 10.3324/haematol.2025.288473. Online ahead of print. |
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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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| JNJ-80948543 | Drug | JNJ-80948543 will be administered subcutaneously. |
|
| JNJ-75348780 | Drug | JNJ-75348780 will be administered subcutaneously. |
|
AUC tau is defined as area under the serum concentration-time curve during a dosing interval (tau).Area under the serum concentration curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
| Up to 2 years 7 months |
| Maximum Serum Concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 | Maximum observed serum concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. | Up to 2 years 7 months |
| Minimum Serum Concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 | Minimum observed serum concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. | Up to 2 years 7 months |
| Area Under the Curve (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 | Area under the curve from time zero to t (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. | Up to 2 years 7 months |
| Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 | Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. | Up to 2 years 7 months |
| Time to Reach Cmax (Tmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 | Tmax is the time to reach maximum observed serum concentartion for JNJ-87801493, JNJ-80948543 and JNJ-75348780. | Up to 2 years 7 months |
| Apparent Total Body Clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 | Apparent total body clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. | Up to 2 years 7 months |
| Apparent Volume of Distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 | Apparent volume of distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. | Up to 2 years 7 months |
| Number of Participants with Presence of Anti-JNJ-87801493, Anti-JNJ- 80948543 and Anti-JNJ-75348780 Antibodies | Number of participants with presence of antibodies binding to JNJ-87801493 or each combination partner (JNJ- 80948543 and JNJ-75348780). | Up to 2 years 7 months |
| Overall Response as Assessed by the Investigator | Overall response is defined as a best response of partial response (PR) or better. | Up to 2 years 7 months |
| Complete Response (CR) as Assessed by the Investigator | Complete response (CR) is defined as a best response of CR. | Up to 2 years 7 months |
| Very Good Partial Response (VGPR) or better for Waldenström Macroglobulinemia (WM) Participants as Assessed by the Investigator | Very good partial response (VGPR) or better is defined as a best response of VGPR or better. | Up to 2 years 7 months |
| Time to Response (TTR) as Assessed by the Investigator | Time to response (TTR) is defined for participants who achieve a response of PR or better as the time from the first dose of any study drug to the first response of PR or better. | Up to 2 years 7 months |
| Duration of Response (DOR) as Assessed by the Investigator | Duration of response (DOR) is defined for participants who achieved a response of PR or better as the time from the first efficacy evaluation at which the participant meet all criteria for a response of PR or better to the date of first documented evidence of progressive disease or death. | Up to 2 years 7 months |
| Melbourne |
| 3004 |
| Australia |
| Linear Clinical Research Ltd | Nedlands | 6009 | Australia |
| Scientia Clinical Research | Randwick | 2031 | Australia |
| Rigshospitalet | Copenhagen | DK-2100 | Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| Hadassah Medical Center | Jerusalem | 9112001 | Israel |
| Sourasky (Ichilov) Medical Center | Tel Aviv | 6423906 | Israel |
| Hosp Univ Vall D Hebron | Barcelona | 08035 | Spain |
| Hosp Univ Fund Jimenez Diaz | Madrid | 28040 | Spain |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37007 | Spain |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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