Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07518186 | A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma | PHASE3 | RECRUITING | 700 | — | — | May 31, 2026 | Dec 8, 2032 | Jun 5, 2026 | 8 | United States, Israel +2 |
| NCT07258511 | A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma | PHASE3 | RECRUITING | 400 | — | — | Feb 4, 2026 | Sep 30, 2031 | Jun 5, 2026 | 65 | United States, Australia +8 |
| NCT07266441 | A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma | PHASE2 | RECRUITING | 157 | — | — | Feb 8, 2026 | Dec 12, 2028 | Jun 5, 2026 | 51 | United States, Israel +4 |
| NCT06768489 | A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma | PHASE1 | RECRUITING | 140 | — | — | Dec 4, 2024 | Nov 23, 2028 | May 8, 2026 | 14 | Australia, Israel +2 |
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.
PFS is defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria.
ORR is defined as the percentage of participants who achieve partial response (PR) or better, according to the international myeloma working group (IMWG) response criteria.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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 (Treatment regimen A1) will receive a dose of 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 regimen A2/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 a dose of 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 a dose of 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. |
| Name | Type | Description |
|---|---|---|
| JNJ-79635322 | DRUG | JNJ-79635322 will be administered as SC injection. |
| Teclistamab | DRUG | Teclistamab will be administered as SC injection. |
| Daratumumab | DRUG | Daratumumab will be administered subcutaneously. |
| Pomalidomide | DRUG | Pomalidomide will be administered orally. |
| Lenalidomide | DRUG | Lenalidomide will be administered orally. |
Inclusion criteria: * Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory * Received 1 to 3 prior lines o...