ClinicalTrials.gov record NCT05652335
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (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
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This first-in-human Phase 1 study evaluates JNJ-79635322, a trispecific antibody, in people with relapsed or refractory multiple myeloma or previously treated AL amyloidosis. Part 1 uses sequential dose escalation to identify the recommended phase 2 dose(s); Part 2 expands those dose(s) to characterize safety and tolerability in disease subgroups. The drug is given by subcutaneous injection and investigators will monitor side effects, lab changes, drug levels, anti-drug antibodies, and preliminary disease response.
What it is studying. The study is testing which dose(s) and schedule(s) of JNJ-79635322 are safe enough to use in later studies and aims to characterize the drug's safety and tolerability. It also collects data on drug levels in the blood, the presence of anti-drug antibodies, laboratory abnormalities, and preliminary measures of anti-cancer activity using disease-specific response criteria.
What the researchers hope to learn. Identify recommended phase 2 dose(s) and schedule(s); characterize safety and tolerability; report adverse events and laboratory abnormalities; measure serum drug concentrations and anti-drug antibodies; and assess preliminary anticancer activity by IMWG and International Amyloidosis Consensus Criteria.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- JNJ-79635322
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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)
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will receive JNJ-79635322 as subcutaneous (under‑the‑skin) injections — doses are escalated in Part 1 to find the recommended Phase 2 dose(s), and Part 2 receives that dose. Study visits include blood tests for drug levels, anti‑drug antibodies and safety labs; disease assessments by blood/urine tests and imaging (for example PET‑CT or whole‑body MRI) as needed; and regular checks for adverse events. If CNS involvement is suspected, brain MRI and lumbar puncture (lumbar cytology) are required. Participants will be followed for safety and response assessments for up to about 2 years and 5 months.
How the study is structured. Phase 1, first‑in‑human interventional trial. Non-randomized, open‑label, sequential dose‑escalation (Part 1) to find recommended phase 2 dose(s), followed by dose‑expansion (Part 2) to assess safety and tolerability at those dose(s) in disease subgroups. JNJ-79635322 is given by subcutaneous injection.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in Belgium, France, Japan, Netherlands, Spain, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on AL amyloidosis
Important dates
- Study start
- Nov 22, 2022
- Primary completion
- Apr 19, 2027 (estimated)
- Study completion
- Nov 15, 2030 (estimated)
- Target enrollment
- 180 participants (estimated)
- Last updated on registry
- Sep 28, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Janssen Research & Development, LLC
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Study Contact 📞 844-434-4210 ✉ Participate-In-This-Study1@its.jnj.com
Participating sites (29)
- City of HopeRecruiting
Duarte, California, 91010 · United States
- City of Hope Orange County Lennar Foundation Cancer CenterRecruiting
Irvine, California, 92618 · United States
- University of California San FranciscoRecruiting
San Francisco, California, 94143 · United States
- Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, 80218 · United States
- Icahn School of Medicine at Mt. SinaiRecruiting
New York, New York, 10029 · United States
- Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, 10065 · United States
- Levine Cancer InstituteRecruiting
Charlotte, North Carolina, 28001 · United States
- University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced MedicineRecruiting
Philadelphia, Pennsylvania, 19104 · United States
- MD Anderson Cancer CenterRecruiting
Houston, Texas, 77030 · United States
- UZ AntwerpenRecruiting
Edegem, 2650 · Belgium
Terms used on this page · explanations by MedicalUpdates.ai
- primary purpose
- The main reason an interventional study is being done, for example treatment, prevention, diagnosis, supportive care or basic science.
- recommended phase 2 dose
- The dose chosen at the end of a phase 1 study for testing in later studies, based on safety and other measurements.
- dose escalation
- Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
- relapsed or refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- prior lines
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- ECOG
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
- at screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- free light chain
- Small pieces of antibody protein made by plasma cells and measured in a blood test. In some conditions, such as AL amyloidosis, abnormal free light chains are the source of the disease.
- Positron Emission Tomography
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
- Computed Tomography
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- magnetic resonance imaging
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- sponsor
- The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
- involved free light chain
- The difference between the abnormal ('involved') and normal ('uninvolved') free light chain levels in the blood. Used in some conditions to decide whether disease is measurable and to track response.
- corticosteroids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- time frame
- The period over which an outcome is measured, for example 'at 12 weeks'. It is not necessarily the total length of the study.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- CAR-T
- A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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