Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-80948543 · 2 trials · 2 indications
Number of participants with DLT will be reported. DLTs are defined as any of the treatment-related toxicities: any toxicity that would require discontinuation of treatment; Fatal toxicity; Non-hematologic toxicity (Grade 3 toxicity or higher with exceptions); and Hematologic Toxicity (Grade 4 neutrophil count decrease; Grade 4 febrile neutropenia; Grade 3 febrile neutropenia that does not recover with best supportive care within 7 days; Grade 4 platelet count decrease for \>=7 days or Grade \>3 with Grade \>=2 bleeding; Grade 4 anemia).
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 4 (Life-threatening). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded as per American Society for Transplantation and Cellular Therapy (ASTCT).
| Arm | Type | Description |
|---|---|---|
| JNJ-80948543 | EXPERIMENTAL | Participants will receive JNJ-80948543 in combination with JNJ-75348780 to determine the recommended phase 2 regimen (RP2R) in Part 1 (Dose escalation). JNJ-80948543 will be dosed in an escalation manner in combination with fixed doses of JNJ-75348780. In Part 2 (Dose expansion) participants will receive RP2R of JNJ-80948543 as determined in Part 1 in combination with JNJ-75348780. |
| Part A: Dose Escalation | EXPERIMENTAL | Participants will receive JNJ-80948543 either by subcutaneous (SC) or intravenous (IV) administration to determine the putative recommended Phase 2 dose (RP2D) dosing schedule(s) and route(s) of administration based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens. |
| Part B: Cohort Expansion | EXPERIMENTAL | Participants will receive JNJ-80948543 by SC or IV administration. |
| Name | Type | Description |
|---|---|---|
| JNJ-80948543 | DRUG | JNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection. |
| JNJ-75348780 | DRUG | JNJ-75348780 will be administered as SC injection. |
Inclusion Criteria: * Histologic documentation of diffuse large B-cell lymphoma (DLBCL), including high-grade B-cell lymphoma and DLBCL arising from indolent lymphoma. All participants must have received at least 2 prior lines of therapy * Participants must have measurable disease as defined by the...
JNJ-80948543 is an investigational small molecule being developed for the treatment of non-Hodgkin lymphoma. It is also being studied in chronic lymphocytic leukemia. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
JNJ-80948543 is a T-cell redirecting CD79b x CD20 x CD3 trispecific antibody. It targets CD79b, CD20, and CD3, which are proteins involved in B-cell signaling and T-cell activation. This mechanism is designed to redirect T-cells to attack B-cell malignancies.
JNJ-80948543 is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain blood cancers.
JNJ-80948543 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The drug is being studied in early-stage trials to assess its safety, tolerability, and preliminary efficacy.
JNJ-80948543 is being studied in two active Phase 1 clinical trials. NCT05424822 evaluates the drug as a monotherapy in patients with non-Hodgkin lymphoma and chronic lymphocytic leukemia. NCT06660563 studies the drug in combination with other CD3 T-cell engagers in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.
Yes, JNJ-80948543 is a trispecific antibody. It is designed to bind to three different targets: CD79b, CD20, and CD3. This trispecific structure allows the drug to simultaneously engage B-cells and T-cells, potentially enhancing its anti-tumor activity in B-cell malignancies.