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Testing JNJ-79635322 for patients with advanced multiple myeloma or AL amyloidosis

Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated AL Amyloidosis

Phase 1 Interventional Janssen Research & Development, LLC · NCT05652335

This study is testing a new drug called JNJ-79635322 to see how much of it is safe to give to people with advanced multiple myeloma or AL amyloidosis who haven't responded to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsCAR-T, prednisone
Locations29 sites (Duarte, California and 28 other locations)
Trial IDNCT05652335 on ClinicalTrials.gov

What this trial studies

This study aims to determine the recommended phase 2 dose and schedule for the drug JNJ-79635322 in patients with relapsed or refractory multiple myeloma or previously treated AL amyloidosis. The trial consists of two parts: the first part focuses on dose escalation to identify safe dosing, while the second part evaluates the safety and tolerability of the selected doses in specific disease subgroups. Participants will be closely monitored for their response to the treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates include individuals with relapsed or refractory multiple myeloma who have undergone multiple lines of prior therapy.

Not a fit: Patients who have not been previously treated for multiple myeloma or AL amyloidosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat multiple myeloma and AL amyloidosis.

How similar studies have performed: Other studies have shown promise with similar therapeutic approaches in treating multiple myeloma, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

For participants with relapsed or refractory multiple myeloma:

* Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
* Part 1: Have relapsed or refractory disease, have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM),and should have been treated with at least 3 prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, and an anti-CD38-based therapy regardless of prior lines of therapy, Part 2: Have relapsed or refractory disease, have been treated with a PI, IMiD and an anti-CD38 based therapy
* Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
* Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL); or b) Urine M-protein level \>=200 milligrams (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \>=10 milligrams per deciliter (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 (EMD) 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 and Computed Tomography (PET-CT) Scans (or whole body magnetic resonance imaging \[MRI\] approved by sponsor), and not previously radiated (Part 2C participants are not required to have measurable disease)

For participants with previously treated AL amyloidosis:

* Initial histopathological diagnosis of amyloidosis
* Participant who is not a candidate for available AL amyloidosis therapy with established clinical benefit and should have received at least 3 cycles of 1 prior line of therapy or a total of at least 2 cycles of 2 or more prior lines of therapy for AL amyloidosis
* Measurable disease at screening defined by at least 1 of the following: serum involved free light chain (iFLC) \>=50 mg/L or difference between involved and uninvolved free light chains (dFLC) \>=50 mg/L, or serum m-protein \>= 0.5 g/dL
* One or more organs impacted by systemic AL amyloidosis
* Left ventricular ejection fraction (LVEF) \>=45%

Exclusion Criteria:

For participants with relapsed or refractory multiple myeloma:

* Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
* Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
* Received a cumulative dose of corticosteroids equivalent to greater than (\>) 140 mg of prednisone within the 14-day period before the start of study treatment administration
* Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: (proteasome inhibitor \[PI\] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days \[not applicable for Part 2C participants\], or CD3-redirecting therapy within 21 days\[not applicable for Part 2B or 2C participants\])
* Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
* Live, attenuated vaccine within 4 weeks before the first dose of study treatment
* Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (\<=) 1 (except alopecia, tissue post-RT fibrosis \[any grade\] or peripheral neuropathy to Grade \<=3)
* 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, autoimmune disease, serious active viral or bacterial infection, uncontrolled systemic fungal infection, cardiac conditions (myocardial infarction \<=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, et cetera)
* Part 2C: have progressive disease or refractory disease per IMWG after CAR-T administration

For participants with previously treated AL amyloidosis:

* CNS involvement or clinical signs of meningeal involvement of AL amyloidosis. If either is suspected, whole brain MRI and lumbar cytology are required
* Any form of non-AL amyloidosis, including but not limited to transthyretin (ATTR) amyloidosis
* Active plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome
* Pulmonary compromise requiring supplemental oxygen use
* Any serious medical conditions such as: active viral, bacterial, fungal infection; active autoimmune disease; HIV infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, significant cardiovascular conditions
* Previous or current diagnosis of symptomatic multiple myeloma
* Macroglossia that impairs swallowing difficulty
* Received a cumulative dose of corticosteroids equivalent to \> 140 mg of prednisone within the 14-day period before the start of study treatment administration
* Prior antitumor therapy within 21 days prior to the first dose of study treatment (PI therapy or radiotherapy within 14 days, IMiD agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days, or CD3-redirecting therapy within 21 days)
* Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
* Live, attenuated vaccine within 4 weeks before the first dose of study treatment
* Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to \<=1 (except alopecia, tissue post-RT fibrosis \[any grade\] or peripheral neuropathy to Grade \<=3)

Where this trial is running

Duarte, California and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed or Refractory Multiple MyelomaPreviously Treated Amyloid Light-chain Amyloidosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.