Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ramantamig
JNJ-79635322 · 7 trials · 5 indications
PFS is defined as the duration from randomization to either confirmed progression of disease (PD) or death, whichever occurs first.
12-month MRD-negative CR rate is defined as participants who achieve MRD-negative status at 12 months (+/-3 months) from randomization, as determined by next-generation sequencing (NGS), prior to PD or subsequent antimyeloma therapy (including ASCT). Additionally, participant must achieve CR or better any time from randomization up to and including 12+3 months prior to PD or subsequent antimyeloma therapy, according to international myeloma working group (IMWG) criteria.
CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria during or after the study treatment.
Overall response is defined as having achieved partial response (PR) or better, according to the international myeloma working group (IMWG) response criteria, as assessed any time after first administration of study treatment, but prior to progression of disease (PD) or subsequent antimyeloma therapy.
Percentage of participants alive and free of treatment-emergent ASTCT Grade \>=2 CRS without the use of intervening treatment for CRS of any grade by the end of day 28 from first ramantamig dose will be reported.
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
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.
Participants with clinically significant laboratory abnormalities (hematology and chemistry) will be reported.
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.
Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.
| Arm | Type | Description |
|---|---|---|
| Arm A: Ramantamig plus Daratumumab (Ramantamig-D) | EXPERIMENTAL | Participants will receive ramantamig D subcutaneous injection. |
| Arm B: Investigator's Choice (DVRd or DRd) | ACTIVE_COMPARATOR | Participants will receive either daratumumab, bortezomib, lenalidomide, dexamethasone (DVRd) or daratumumab, lenalidomide, dexamethasone (DRd) as per investigator's choice. |
| Arm A: JNJ-79635322 | EXPERIMENTAL | Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first). |
| Arm B: Teclistamab | ACTIVE_COMPARATOR | Participants will receive teclistamab as a SC injection until PD or intolerable toxicity. |
| JNJ-79635322 | EXPERIMENTAL | Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity. |
| Anti BCMAxCD3 Bispecific Antibody | ACTIVE_COMPARATOR | Participants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity. |
| Arm A: Tocilizumab + Ramantamig | EXPERIMENTAL | Participants will receive tocilizumab along with ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until progressive disease (PD) or intolerable toxicity (whichever is earlier). |
| Arm B: Placebo + Ramantamig | PLACEBO_COMPARATOR | Participants will receive placebo (saline) along with ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until PD or intolerable toxicity (whichever is earlier). |
| 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. |
| 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. |
| Treatment Regimen F: JNJ-79635322 + Daratumumab | EXPERIMENTAL | Participants with newly diagnosed amyloid light chain (ND AL) amyloidosis will receive JNJ-79635322 in treatment regimen F along with daratumumab 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 and daratumumab 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 G: JNJ-79635322 + Daratumumab | EXPERIMENTAL | Participants with high-risk smoldering multiple myeloma (SMM) will receive JNJ-79635322 in treatment regimen G along with daratumumab 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 and daratumumab at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens. |
| 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 |
|---|---|---|
| Ramantamig | DRUG | Ramantamig will be administered subcutaneously. |
| Daratumumab | DRUG | Daratumumab will be administered subcutaneously. |
| Lenalidomide | DRUG | Lenalidomide will be administered orally. |
| Bortezomib | DRUG | Bortezomib will be administered subcutaneously or intravenously. |
| Dexamethasone | DRUG | Dexamethasone will be administered orally or intravenously. |
| JNJ-79635322 | DRUG | JNJ-79635322 will be administered as SC injection. |
| Teclistamab | DRUG | Teclistamab will be administered as SC injection. |
| Tocilizumab | DRUG | Tocilizumab will be administered as intravenous (IV) injection. |
| Placebo | DRUG | Placebo (saline) will be administered as IV injection. |
| Pomalidomide | DRUG | Pomalidomide will be administered orally. |
Inclusion criteria: * Documented diagnosis of multiple myeloma (MM) according to the IMWG diagnostic criteria * Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: i. ineligible due to advanced age; or ii. ineligible due to presence of comorbid conditi...
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JNJ-79635322 is an investigational small molecule being studied for multiple myeloma, including relapsed or refractory multiple myeloma. Clinical trials also include newly diagnosed AL amyloidosis and high-risk smoldering multiple myeloma. It is not yet approved for any indication and remains in clinical development.
JNJ-79635322 targets BCMA, or B-cell maturation antigen, a protein expressed on myeloma cells. By binding BCMA, the drug is designed to act on this target in multiple myeloma. BCMA is also the target of approved bispecific antibodies used in relapsed or refractory disease.
JNJ-79635322 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is running the clinical program across multiple countries, including the United States, Europe, and Asia, in relapsed or refractory multiple myeloma and related plasma cell disorders.
JNJ-79635322 is in Phase 3 development. Two Phase 3 trials are recruiting, one comparing it with teclistamab and another comparing it with a BCMA x CD3 bispecific antibody in relapsed or refractory multiple myeloma. A Phase 2 study is active but not recruiting, and a Phase 1 combination study is recruiting.
JNJ-79635322 is being studied in four active trials. NCT07518186 is a Phase 3 comparison with teclistamab, and NCT07258511 is a Phase 3 comparison with a BCMA x CD3 bispecific antibody. NCT07266441 is a Phase 2 study, and NCT06768489 is a Phase 1 combination study with daratumumab and lenalidomide or pomalidomide.
The JNJ-79635322 clinical program has a planned total enrollment of 1,544 participants across four active trials. The Phase 3 studies plan to enroll 700 and 400 participants, the Phase 2 study 168, and the Phase 1 combination study 276. All trials enroll adults aged 18 years and older.