Relapsed or Refractory Multiple MyelomaPhase 1NCT05652335
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis
A Phase 1 study testing JNJ-79635322 in people with Relapsed or Refractory Multiple Myeloma and Previously Treated Amyloid Light-chain (AL) Amyloidosis, run by Janssen Research & Development, LLC at 29 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma, Previously Treated Amyloid Light-chain (AL) Amyloidosis
- What is being tested?
- JNJ-79635322
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 29 sitesin 7 countries
- Study dates
- 22 Nov 2022to 15 Nov 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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%
Who cannot join
- 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
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- 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)
Trial locations and contacts
29 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
29 sites in 7 countries
United States9 sites, 9 recruiting
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28001
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Recruiting
City of Hope
Duarte, California, 91010
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
- Recruiting
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Spain5 sites, 5 recruiting
- Recruiting
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
- Recruiting
Hosp Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
- Recruiting
Clinica Univ. de Navarra
Pamplona, 31008
- Recruiting
Hosp Clinico Univ de Salamanca
Salamanca, 37007
France4 sites, 3 recruiting
- Recruiting
CHU Nantes
Nantes, 44093
- Recruiting
CHU Lyon Sud
Pierre-Bénite, 69495
- Completed
Chu Rennes Hopital Pontchaillou
Rennes, 35000
- Recruiting
Institut Claudius Regaud
Toulouse, 31100
Belgium3 sites, 3 recruiting
- Recruiting
UZ Antwerpen
Edegem, 2650
- Recruiting
UZ Gent
Ghent, 9000
- Recruiting
CHU de Liege
Liège, 4000
Japan3 sites, 2 recruiting
- Recruiting
Japanese Red Cross Medical Center
Shibuya City, 150-8935
- Recruiting
Osaka University Hospital
Suita-shi, 565-0871
- Completed
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Netherlands3 sites, 3 recruiting
- Recruiting
VUMC Amsterdam
Amsterdam, 1081 HV
- Recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
- Recruiting
UMC Utrecht
Utrecht, 3584 CX
United Kingdom2 sites, 2 recruiting
- Recruiting
University College Hospital
London, W1T 7HA
- Recruiting
Royal Marsden Hospital
Sutton, SM2 5PT
About this study
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
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).
- Conditions
- Relapsed or Refractory Multiple Myeloma, Previously Treated Amyloid Light-chain (AL) Amyloidosis
- Being tested
- JNJ-79635322
- Medical subject headings
- Recurrence, Multiple Myeloma, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-79635322Drug
JNJ-79635322 will be administered as SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. Receives: Drug: JNJ-79635322 |
| Part 2: Dose Expansion | Experimental | Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1. Receives: Drug: JNJ-79635322 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years 5 months
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.
Measured: Up to 2 years 5 months
Part 2: Number of Participants with Abnormalities in Laboratory Values
Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.
Measured: Up to 2 Years 5 months
Secondary outcomes (8)
Serum Concentration of JNJ-79635322
Serum samples will be analyzed to determine concentrations of JNJ-79635322.
Measured: Up to 2 Years 5 months
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.
Measured: Up to 2 Years 5 months
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.
Measured: Up to 2 Years 5 months
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.
Measured: Up to 2 Years 5 months
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.
Measured: Up to 2 Years 5 months
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.
Measured: Up to 2 Years 5 months
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.
Measured: Up to 2 Years 5 months
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.
Measured: Up to 2 Years 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start22 Nov 2022
- Primary completion19 Apr 2027 (estimated)
- Study completion15 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652335
- Sponsor's protocol ID
- CR109234
- Other IDs
- 79635322MMY1001, 2022-001465-12, 2023-503679-12-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 7 Dec 2022
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
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