Testing JNJ-79635322 for patients with advanced multiple myeloma or AL amyloidosis
Official title: 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
Run by Janssen Research & Development, LLC · NCT05652335 · Data updated 2026-11-12
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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | CAR-T, prednisone |
| Locations | 29 sites (Duarte, California and 28 other locations) |
| Status | Recruiting |
| Started | November 22, 2022 |
| Main results expected | April 19, 2027 |
| Study ends | November 15, 2030 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT05652335 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with relapsed or refractory multiple myeloma who have undergone multiple lines of prior therapy.
✕Probably not a fit
Patients who have not been previously treated for multiple myeloma or AL amyloidosis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise with similar therapeutic approaches in treating multiple myeloma, indicating potential for success in this trial.
Who can join: the full rules
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 it's running
-
City of Hope
Duarte, California, United States Recruiting -
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States Recruiting -
University of California San Francisco
San Francisco, California, United States Recruiting -
Colorado Blood Cancer Institute
Denver, Colorado, United States Recruiting -
Icahn School of Medicine at Mt. Sinai
New York, New York, United States Recruiting -
Memorial Sloan Kettering Cancer Center
New York, New York, United States Recruiting
Show 23 more locations
-
Levine Cancer Institute
Charlotte, North Carolina, United States Recruiting -
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States Recruiting -
MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
UZ Antwerpen
Edegem, Belgium Recruiting -
UZ Gent
Ghent, Belgium Recruiting -
CHU de Liege
Liège, Belgium Recruiting -
CHU Nantes
Nantes, France Recruiting -
CHU Lyon Sud
Pierre-Bénite, France Recruiting -
Institut Claudius Regaud
Toulouse, France Recruiting -
VUMC Amsterdam
Amsterdam, Netherlands Recruiting -
Universitair Medisch Centrum Groningen
Groningen, Netherlands Recruiting -
UMC Utrecht
Utrecht, Netherlands Recruiting -
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain Recruiting -
Hosp Clinic de Barcelona
Barcelona, Spain Recruiting -
Hosp Univ Fund Jimenez Diaz
Madrid, Spain Recruiting -
Clinica Univ. de Navarra
Pamplona, Spain Recruiting -
Hosp Clinico Univ de Salamanca
Salamanca, Spain Recruiting -
University College Hospital
London, United Kingdom Recruiting -
Royal Marsden Hospital
Sutton, United Kingdom Recruiting -
Chu Rennes Hopital Pontchaillou
Rennes, France Completed -
Japanese Red Cross Medical Center
Shibuya City, Japan Active not recruiting -
Osaka University Hospital
Suita-shi, Japan Active not recruiting -
The Cancer Institute Hospital of JFCR
Tokyo, Japan Completed
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AZD4045 in Relapsed or Refractory Multiple Myeloma
This study tests AZD4045 alone and with daratumumab and aldesleukin in adults whose multiple myeloma has returned or stopped responding to treatment.
-
A new treatment approach for relapsed or refractory multiple myeloma in adults
This study tests if IBI3003 works better than the investigator's choice treatment for adults whose multiple myeloma has returned or persisted after prior therapy.
-
O&D-001 CAR‑T injection for relapsed or refractory multiple myeloma
This trial will test a CAR‑T injection called O&D‑001 that targets BCMA and GPRC5D in adults with relapsed or refractory multiple myeloma who have had at least two prior therapies.
-
F182112 given with other drugs for relapsed or refractory multiple myeloma
This trial will test whether F182112, given with different drug regimens, helps people whose multiple myeloma has returned or stopped responding to prior treatments.
-
QLS32015 versus pomalidomide+dexamethasone or selinexor+dexamethasone for relapsed or refractory multiple myeloma
This will see if QLS32015 alone controls disease and is safe compared with pomalidomide+dexamethasone or selinexor+dexamethasone in adults with relapsed or refractory multiple myeloma who have had at least three prior treatments.
-
mRNA-2808 for relapsed or refractory multiple myeloma
This will test whether mRNA-2808 is safe and tolerable for people with relapsed or refractory multiple myeloma who have already received standard therapies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.