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Adjusted LOA
ML Risk
JNJ-87801493 · 1 trial · 1 indication
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
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 \[ICANS\]).
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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 |
|---|---|---|
| JNJ-87801493 | DRUG | JNJ-87801493 will be administered subcutaneously. |
| JNJ-80948543 | DRUG | JNJ-80948543 will be administered subcutaneously. |
| JNJ-75348780 | DRUG | JNJ-75348780 will be administered subcutaneously. |
Inclusion Criteria: * Histologic documentation of B-cell NHL. All participants in part 1 must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment. In Part 2, participants with diffuse large B-cell lymphoma (DLB...
JNJ-87801493 is an investigational small molecule being studied for the treatment of B-cell non-Hodgkin lymphoma (NHL). It is currently in Phase 1 clinical development, evaluated in combination with T-cell engagers in patients with this type of cancer.
The specific molecular target of JNJ-87801493 is not disclosed in the available information. It is a small molecule being studied in combination with T-cell engagers for B-cell non-Hodgkin lymphoma, but its precise mechanism of action has not been specified.
JNJ-87801493 is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting a Phase 1 clinical trial of this investigational small molecule for the treatment of B-cell non-Hodgkin lymphoma.
JNJ-87801493 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied in an active but not recruiting clinical trial for non-Hodgkin lymphoma.
JNJ-87801493 is being studied in clinical trial NCT06139406, titled 'A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer.' This Phase 1 trial has an enrollment of 70 participants and is active but not recruiting, with sites in Australia, Denmark, Israel, and Spain.