A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously T

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

Last Updated April 22, 2025

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CR109234

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 1

1
Sites
29 Sites
Status

Recruiting

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

ELIGIBILITY

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)

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

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DETAILS

LOCATIONS

Locations in:

United States, Belgium, France, Japan, Netherlands, Spain, United Kingdom

Country (7)	City or Province (29)	Status
United States	Duarte City of Hope	RECRUITING
United States	Irvine City of Hope Orange County Lennar Foundation Cancer Center	RECRUITING
United States	San Francisco University of California San Francisco	RECRUITING
United States	Denver Colorado Blood Cancer Institute	RECRUITING
United States	New York Icahn School of Medicine at Mt. Sinai	RECRUITING
United States	New York Memorial Sloan Kettering Cancer Center	RECRUITING
United States	Charlotte Levine Cancer Institute	RECRUITING
United States	Philadelphia University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine	RECRUITING
United States	Houston MD Anderson Cancer Center	RECRUITING
Belgium	Edegem UZ Antwerpen	RECRUITING
Belgium	Gent UZ Gent	RECRUITING
Belgium	Liege CHU de Liege	RECRUITING
France	Nantes CHU Nantes	RECRUITING
France	Pierre benite CHU Lyon Sud	RECRUITING
France	Toulouse Institut Claudius Regaud	RECRUITING
Japan	Suita-shi Osaka University Hospital	RECRUITING
Netherlands	Amsterdam VUMC Amsterdam	RECRUITING
Netherlands	Utrecht UMC Utrecht	RECRUITING
Spain	Badalona Hosp. Univ. Germans Trias I Pujol	RECRUITING
Spain	Barcelona Hosp Clinic de Barcelona	RECRUITING
Spain	Madrid Hosp Univ Fund Jimenez Diaz	RECRUITING
Spain	Pamplona Clinica Univ. de Navarra	RECRUITING
Spain	Salamanca Hosp Clinico Univ de Salamanca	RECRUITING
United Kingdom	London University College Hospital	RECRUITING
United Kingdom	Sutton Royal Marsden Hospital	RECRUITING
Japan	Shibuya Japanese Red Cross Medical Center	RECRUITING
Japan	Tokyo The Cancer Institute Hospital of JFCR	RECRUITING
Netherlands	Groningen Universitair Medisch Centrum Groningen	RECRUITING
France	Rennes Chu Rennes Hopital Pontchaillou	COMPLETED

Geo Locations

34.13945, -117.97729

33.66946, -117.82311

37.77493, -122.41942

39.73915, -104.9847

40.71427, -74.00597

35.22709, -80.84313

39.95233, -75.16379

29.76328, -95.36327

51.15662, 4.44504

51.05, 3.71667

50.63373, 5.56749

47.21725, -1.55336

45.7009, 4.82511

43.60426, 1.44367

34.76143, 135.51567

52.37403, 4.88969

52.09083, 5.12222

41.45004, 2.24741

41.38879, 2.15899

40.4165, -3.70256

42.81687, -1.64323

40.96882, -5.66388

51.50853, -0.12574

51.35, -0.2

35.469, 140.29807

35.6895, 139.69171

53.21917, 6.56667

48.11198, -1.67429

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

LOCATIONS

34.13945, -117.97729

33.66946, -117.82311

37.77493, -122.41942

39.73915, -104.9847

40.71427, -74.00597

40.71427, -74.00597

35.22709, -80.84313

39.95233, -75.16379

29.76328, -95.36327

51.15662, 4.44504

51.05, 3.71667

50.63373, 5.56749

47.21725, -1.55336

45.7009, 4.82511

43.60426, 1.44367

34.76143, 135.51567

52.37403, 4.88969

52.09083, 5.12222

41.45004, 2.24741

41.38879, 2.15899

40.4165, -3.70256

42.81687, -1.64323

40.96882, -5.66388

51.50853, -0.12574

51.35, -0.2

35.469, 140.29807

35.6895, 139.69171

53.21917, 6.56667

48.11198, -1.67429

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