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

NCT05652335 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: CR10923479635322MMY10012022-001465-122023-503679-12-00
• Study Type: interventional
• Target: 180
• Locations: 7 countries
• Sites: 29

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to 2 Years 5 months

Secondary Outcomes (8)

• Serum Concentration of JNJ-79635322

  Up to 2 Years 5 months

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

  Up to 2 Years 5 months

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

  Up to 2 Years 5 months

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

  Up to 2 Years 5 months

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

  Up to 2 Years 5 months

Study Arms (2)

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.

Drug: JNJ-79635322

Part 2: Dose Expansion

EXPERIMENTAL

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

Drug: JNJ-79635322

Interventions

JNJ-79635322 DRUG

JNJ-79635322 will be administered as SC injection.

Part 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (29)

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

ACTIVE NOT RECRUITING

Osaka University Hospital

Suita-shi, 565-0871, Japan

ACTIVE NOT 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

Related Publications (1)

• 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.

  PMID: 41100731 DERIVED

MeSH Terms

Conditions

Recurrence; Multiple Myeloma; Amyloidosis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: November 22, 2022
• Primary Completion (Estimated): April 19, 2027
• Study Completion (Estimated): August 7, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (9); NL (3); JP (3); FR (4); BE (3); ES (5); GB (2)