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RecruitingLast updated: 27 November 2025

Trilogy 2: A study recruiting people with multiple myeloma to identify the safe and effective dose of a new drug when given in combination with other treatmentsA Phase 1b Study of JNJ-79635322 in Combination With Daratumumab or Pomalidomide for Multiple Myeloma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

Trilogy 2

Clinical summary

Summary

This study has two parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). Each treatment arm will follow the two parts.

  • The goal of Part 1 will be to identify safe and effective dose (called RP2D) to test further in Part 2, and to determine the dosing schedule.
  • The goal of Part 2 will be to further study how safe and tolerable these treatments are at the RP2D identified in Part 1.

Eligible participants will be assigned to one of two treatment arms, depending on whether they have had prior treatment or not.

Experimental Treatment Regimen A and C Arms

This arm will involve participants who have received:

  • 1-3 prior lines of therapy, including a proteasome inhibitor (PI) and
  • an immunomodulating drug (Treatment regimen A1).

Participants will receive a dose of JNJ-79635322 plus with daratumumab to establish the RP2Ds of JNJ-79635322 during Part 1 of the study. 

In Part 2 participants will receive a dose of JNJ-79635322 combination treatmen regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s).

Experimental Treatment Regimen B Arm

This arm will enrol people who have received:

  • great than or equal to 1 prior line of therapy, including a PI and lenalidomide, and
  • are lenalidomide refractory or more than or equal to 2 prior lines of therapy, including a PI and lenalidomide.

Participants will receive a dose of JNJ-79635322 along with pomalidomide to establish the RP2D(s) of the JNJ-79635322 during Part 1 of the study.

In Part 2, participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part  and in disease subgroup(s).

Experimental Treatment Regimen D and E Arms

This arm will enrol people with newly diagnosed multiple myeloma (NDMM).

Participants will receive a dose of JNJ-79635322 along with daratumumab and lenalidomide to establish the RP2D(s) of the JNJ079635322 during Part 1.

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).

Conditions

This trial is treating people with multiple myeloma, who either have or have not had prior treatment

Eligibility

Inclusion

  • Have documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria
  • Meet treatment regimen-specific requirements as follows: Treatment regimen A (JNJ-79635322+daratumumab):Treatment regimen A1: Have been treated with 1 to 3 prior lines of therapy, including a proteasome inhibitor (PI) and an inhibitor, immunomodulatory drug (IMiD) therapy for the treatment of multiple myeloma (MM); Treatment regimen A2: Newly diagnosed MM naïve to multiple myeloma (or other related plasma cell neoplasm)-directed treatments; Treatment regimen B (JNJ-79635322+pomalidomide): 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
  • Have a weight >=40 kilograms
  • Must have an Eastern Cooperative Oncology Group status of 0 or 2
  • Have measurable disease at screening as defined by at least 1 of the following: a) Serum monoclonal protein (M-protein) level >= 0.5 gram per deciliter (g/dL); or b) Urine M-protein level >=200 milligram (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal serum Ig kappa lambda FLC ratio. d) For participants without measurable disease in the serum, urine, or involved FLC: presence of 1 or more focus of extramedullary disease which meets the following criteria: extramedullary plasmacytoma not contiguous with a bone lesion, at least 1 lesion >=2 centimeter (cm) (at its greatest dimension) diameter on whole body positron emission tomography-computed tomography (or whole-body magnetic resonance imaging approved by sponsor), and not previously radiated

Exclusion

  • Any serious underlying medical conditions, such as: a) Evidence of active viral, bacterial, or systemic fungal infection requiring ongoing antiviral, antibacterial, or antifungal treatment. b) Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment. c) Cardiac conditions (myocardial infarction, unstable angina, or coronary artery bypass graft <=6 months prior to enrollment; New york heart association stage III or IV congestive heart failure etcetera)
  • Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: a) Targeted therapy, epigenetic therapy, monoclonal antibody (mAb) treatment, or treatment with an investigational drug or an invasive investigational medical device within 21 days or 5 half-lives, whichever is less. b) Gene-modified adoptive cell therapy (example, chimeric antigen receptor [CAR] modified T cells, natural killer cells) within 90 days. c) Prior anti-CD38 directed therapy within 90 days (for treatment regimen A only; within 21 days for treatment regimen B). d) Conventional chemotherapy within 21 days. e) PI therapy within 14 days. f) Immunomodulatory agent therapy within 7 days. g) Radiotherapy within 14 days
  • Stem cell transplantation: a) Allogeneic stem cell transplant within 6 months before the first dose of study treatment. b) Received an autologous stem cell transplant less than or equal to (<=)12 weeks before the first dose of study treatment
  • Nonhematologic toxicity from prior anticancer therapy that has not resolved to baseline level or to grade <=1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy grade <=3)
  • Prior treatment with CD3-redirecting therapy
  • The following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

  • NCT06768489 *
  • 79635322MMY1002; 79635322MMY1002; 2024-515316-44-00

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 1b Study of JNJ-79635322 in Combination With Daratumumab or Pomalidomide for Multiple Myeloma

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