Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05652335

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

Led by Janssen Research & Development, LLC · Updated on 2026-05-08

180

Participants Needed

29

Research Sites

300 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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%
Not Eligible

You will not qualify if you...

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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 29 locations

1

City of Hope

Duarte, California, United States, 91010

Actively Recruiting

2

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States, 92618

Actively Recruiting

3

University of California San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

4

Colorado Blood Cancer Institute

Denver, Colorado, United States, 80218

Actively Recruiting

5

Icahn School of Medicine at Mt. Sinai

New York, New York, United States, 10029

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

7

Levine Cancer Institute

Charlotte, North Carolina, United States, 28001

Actively Recruiting

8

University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

9

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

10

UZ Antwerpen

Edegem, Belgium, 2650

Actively Recruiting

11

UZ Gent

Ghent, Belgium, 9000

Actively Recruiting

12

CHU de Liege

Liège, Belgium, 4000

Actively Recruiting

13

CHU Nantes

Nantes, France, 44093

Actively Recruiting

14

CHU Lyon Sud

Pierre-Bénite, France, 69495

Actively Recruiting

15

Chu Rennes Hopital Pontchaillou

Rennes, France, 35000

Completed

16

Institut Claudius Regaud

Toulouse, France, 31100

Actively Recruiting

17

Japanese Red Cross Medical Center

Shibuya City, Japan, 150-8935

Actively Recruiting

18

Osaka University Hospital

Suita-shi, Japan, 565-0871

Actively Recruiting

19

The Cancer Institute Hospital of JFCR

Tokyo, Japan, 135-8550

Completed

20

VUMC Amsterdam

Amsterdam, Netherlands, 1081 HV

Actively Recruiting

21

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

Actively Recruiting

22

UMC Utrecht

Utrecht, Netherlands, 3584 CX

Actively Recruiting

23

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain, 08916

Actively Recruiting

24

Hosp Clinic de Barcelona

Barcelona, Spain, 08036

Actively Recruiting

25

Hosp Univ Fund Jimenez Diaz

Madrid, Spain, 28040

Actively Recruiting

26

Clinica Univ. de Navarra

Pamplona, Spain, 31008

Actively Recruiting

27

Hosp Clinico Univ de Salamanca

Salamanca, Spain, 37007

Actively Recruiting

28

University College Hospital

London, United Kingdom, W1T 7HA

Actively Recruiting

29

Royal Marsden Hospital

Sutton, United Kingdom, SM2 5PT

Actively Recruiting

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Research Team

S

Study Contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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