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RecruitingNCT05652335Updated Sep 28, 2026

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

A Phase 1 interventional study of JNJ-79635322 in Relapsed or Refractory Multiple Myeloma and Previously Treated Amyloid Light-chain (AL) Amyloidosis, sponsored by Janssen Research & Development, LLC. Recruiting at 29 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Relapsed or Refractory Multiple Myeloma
  • Previously Treated Amyloid Light-chain (AL) Amyloidosis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Part 1: Dose Escalation

    Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.

    Drug: JNJ-79635322

  • Experimental
    Part 2: Dose Expansion

    Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.

    Drug: JNJ-79635322

Interventions

  • DrugJNJ-79635322

    JNJ-79635322 will be administered as SC injection.

05

What researchers measure

Primary outcomes

  1. Part 1: Number of Participants with Dose-limiting Toxicity (DLT)

    DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

    Time frame: Up to 2 years 5 months

  2. Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity

    An adverse event 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.

    Time frame: Up to 2 years 5 months

  3. Part 2: Number of Participants with Abnormalities in Laboratory Values

    Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.

    Time frame: Up to 2 Years 5 months

Secondary outcomes

  1. Serum Concentration of JNJ-79635322

    Serum samples will be analyzed to determine concentrations of JNJ-79635322.

    Time frame: Up to 2 Years 5 months

  2. Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322

    Number of participants with presence of anti-drug antibodies to JNJ-79635322 will be reported.

    Time frame: Up to 2 Years 5 months

  3. Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Myeloma Working Group (IMWG) 2016 Response Criteria

    Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.

    Time frame: Up to 2 Years 5 months

  4. Time to Response (TTR) as Defined by IMWG 2016 Response Criteria

    TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for partial response (PR) or better as defined by IMWG 2016 response criteria.

    Time frame: Up to 2 Years 5 months

  5. Duration of Response (DOR) as Defined by IMWG 2016 Response Criteria

    DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG 2016 response criteria, or death due to any cause, whichever occurs first.

    Time frame: Up to 2 Years 5 months

  6. Part 2: Time to Response (TTR) as Defined by International Amyloidosis Consensus Criteria

    TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for PR or better as defined by International Amyloidosis Consensus Criteria.

    Time frame: Up to 2 Years 5 months

  7. Part 2: Duration of Response (DOR) as Defined by International Amyloidosis Consensus Criteria

    DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per International Amyloidosis Consensus Criteria or death due to any cause, whichever occurs first.

    Time frame: Up to 2 Years 5 months

  8. Part 2: Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Amyloidosis Consensus Criteria

    Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Amyloidosis Consensus Criteria.

    Time frame: Up to 2 Years 5 months

06

Study locations

27 of 29 sites recruiting
  • City of Hope
    Duarte, California 91010, United States
    Recruiting
  • City of Hope Orange County Lennar Foundation Cancer Center
    Irvine, California 92618, United States
    Recruiting
  • University of California San Francisco
    San Francisco, California 94143, United States
    Recruiting
  • Colorado Blood Cancer Institute
    Denver, Colorado 80218, United States
    Recruiting
  • Icahn School of Medicine at Mt. Sinai
    New York, New York 10029, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    Recruiting
  • Levine Cancer Institute
    Charlotte, North Carolina 28001, United States
    Recruiting
  • University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
  • UZ Antwerpen
    Edegem, 2650, Belgium
    Recruiting
  • UZ Gent
    Ghent, 9000, Belgium
    Recruiting
  • CHU de Liege
    Liège, 4000, Belgium
    Recruiting
  • CHU Nantes
    Nantes, 44093, France
    Recruiting
  • CHU Lyon Sud
    Pierre-Bénite, 69495, France
    Recruiting
  • Chu Rennes Hopital Pontchaillou
    Rennes, 35000, France
    Completed
  • Institut Claudius Regaud
    Toulouse, 31100, France
    Recruiting
  • Japanese Red Cross Medical Center
    Shibuya City, 150-8935, Japan
    Recruiting
  • Osaka University Hospital
    Suita-shi, 565-0871, Japan
    Recruiting
  • The Cancer Institute Hospital of JFCR
    Tokyo, 135-8550, Japan
    Completed
  • VUMC Amsterdam
    Amsterdam, 1081 HV, Netherlands
    Recruiting
  • Universitair Medisch Centrum Groningen
    Groningen, 9713 GZ, Netherlands
    Recruiting
  • UMC Utrecht
    Utrecht, 3584 CX, Netherlands
    Recruiting
  • Hosp. Univ. Germans Trias I Pujol
    Badalona, 08916, Spain
    Recruiting
  • Hosp Clinic de Barcelona
    Barcelona, 08036, Spain
    Recruiting
  • Hosp Univ Fund Jimenez Diaz
    Madrid, 28040, Spain
    Recruiting
  • Clinica Univ. de Navarra
    Pamplona, 31008, Spain
    Recruiting
  • Hosp Clinico Univ de Salamanca
    Salamanca, 37007, Spain
    Recruiting
  • University College Hospital
    London, W1T 7HA, United Kingdom
    Recruiting
  • Royal Marsden Hospital
    Sutton, SM2 5PT, United Kingdom
    Recruiting
07

References and documents

Publications

  • Pillarisetti K, Yang D, Luistro L, Yao J, Smith M, Vulfson P, Testa JS, Ponticiello R, Brodeur S, Heidrich B, Packman K, Singh S, Attar R, Elsayed Y, Philippar U. Ramantamig (JNJ-79635322), a novel T-cell-engaging trispecific antibody targeting BCMA, GPRC5D, and CD3, in multiple myeloma models. Blood. 2026 Feb 19;147(8):834-847. doi: 10.1182/blood.2025030027. PubMed 41100731 ↗

Individual participant data

Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

08

Registry details

Key details

Study ID
NCT05652335
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Dec 15, 2022
Start date
Nov 22, 2022
Primary completion
Apr 19, 2027 (estimated)
Completion
Nov 15, 2030 (estimated)
Last update
Sep 28, 2026

Study contacts

Study Contact
Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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