Phase
Condition
Multiple Myeloma
Amyloidosis
Leukemia
Treatment
JNJ-79635322
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For participants with relapsed or refractory multiple myeloma:
Have a documented initial diagnosis of multiple myeloma according to InternationalMyeloma Working Group (IMWG) diagnostic criteria
Part 1: Have relapsed or refractory disease, have been treated with a proteasomeinhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy forthe treatment of multiple myeloma (MM),and should have been treated with at least 3prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, andan anti-CD38-based therapy regardless of prior lines of therapy, Part 2: Haverelapsed or refractory disease, have been treated with a PI, IMiD and an anti-CD38based 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 chainmultiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligramsper deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio; d) Forparticipants without measurable disease in the serum, urine, or involved FLC,presence of 1 or more focus of extramedullary disease (EMD) which meets thefollowing criteria: extramedullary plasmacytoma not contiguous with a bone lesion,at least 1 lesion >=2 centimeter [cm] (at its greatest dimension) diameter on wholebody Positron Emission Tomography and Computed Tomography (PET-CT) Scans (or wholebody magnetic resonance imaging [MRI] approved by sponsor), and not previouslyradiated (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 withestablished clinical benefit and should have received at least 3 cycles of 1 priorline of therapy or a total of at least 2 cycles of 2 or more prior lines of therapyfor AL amyloidosis
Measurable disease at screening defined by at least 1 of the following: seruminvolved free light chain (iFLC) >=50 mg/L or difference between involved anduninvolved 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
Exclusion Criteria:
For participants with relapsed or refractory multiple myeloma:
Central Nervous System (CNS) involvement or clinical signs of meningeal involvementof 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), orprimary light chain amyloidosis
Received a cumulative dose of corticosteroids equivalent to greater than (>) 140 mgof prednisone within the 14-day period before the start of study treatmentadministration
Prior antitumor therapy as follows, in the specified time frame prior to the firstdose of study treatment: (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modifiedadoptive cell therapy within 90 days [not applicable for Part 2C participants], orCD3-redirecting therapy within 21 days[not applicable for Part 2B or 2Cparticipants])
Prior allogeneic transplant within 6 months before the start of study treatmentadministration or autologous transplant within 12 weeks before the start of studytreatment 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 tobaseline levels or to Grade less than or equal to (<=) 1 (except alopecia, tissuepost-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3)
The following medical conditions: pulmonary compromise requiring supplemental oxygenuse to maintain adequate oxygenation, human immunodeficiency (HIV) infection, activehepatitis B or C infection, stroke or seizure within 6 months prior to first dose ofstudy 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 IVcongestive heart failure, et cetera)
Part 2C: have progressive disease or refractory disease per IMWG after CAR-Tadministration
For participants with previously treated AL amyloidosis:
CNS involvement or clinical signs of meningeal involvement of AL amyloidosis. Ifeither 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, strokeor seizure within 6 months prior to first dose of study treatment, significantcardiovascular 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 prednisonewithin 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 therapywithin 21 days)
Prior allogeneic transplant within 6 months before the start of study treatmentadministration or autologous transplant within 12 weeks before the start of studytreatment 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 tobaseline levels or to <=1 (except alopecia, tissue post-RT fibrosis [any grade] orperipheral neuropathy to Grade <=3)
Study Design
Connect with a study center
UZ Antwerpen
Edegem, 2650
BelgiumActive - Recruiting
UZ Gent
Gent, 9000
BelgiumActive - Recruiting
CHU de Liege
Liege, 4000
BelgiumActive - Recruiting
CHU de Liège
Liege, 4000
BelgiumActive - Recruiting
CHU Nantes
Nantes, 44093
FranceActive - Recruiting
CHU Lyon Sud
Pierre benite, 69495
FranceActive - Recruiting
Chu Rennes - Hopital Pontchaillou
Rennes, 35000
FranceActive - Recruiting
Chu Rennes Hopital Pontchaillou
Rennes, 35000
FranceCompleted
Institut Claudius Regaud
Toulouse, 31100
FranceActive - Recruiting
Japanese Red Cross Medical Center
Shibuya, 150-8935
JapanActive - Recruiting
Osaka University Hospital
Suita-shi, 565-0871
JapanActive - Recruiting
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
JapanActive - Recruiting
VUMC Amsterdam
Amsterdam, 1081 HV
NetherlandsActive - Recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
NetherlandsActive - Recruiting
UMC Utrecht
Utrecht, 3584 CX
NetherlandsActive - Recruiting
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
SpainActive - Recruiting
Hosp Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp. Clinic I Provincial de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp. Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
Hosp. Univ. Fund. Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
Clinica Univ. de Navarra
Pamplona, 31008
SpainActive - Recruiting
Hosp Clinico Univ de Salamanca
Salamanca, 37007
SpainActive - Recruiting
Hosp. Clinico Univ. de Salamanca
Salamanca, 37007
SpainActive - Recruiting
University College Hospital
London, W1T 7HA
United KingdomActive - Recruiting
The Christie NHS Foundation Trust - Christie Hospital
Manchester, M20 4BX
United KingdomSite Not Available
Royal Marsden Hospital
Sutton, SM2 5PT
United KingdomActive - Recruiting
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California 92618
United StatesActive - Recruiting
University of California San Francisco
San Francisco, California 94143
United StatesActive - Recruiting
Colorado Blood Cancer Institute
Denver, Colorado 80218
United StatesActive - Recruiting
Icahn School of Medicine at Mt. Sinai
New York, New York 10029
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Levine Cancer Institute
Charlotte, North Carolina 28001
United StatesActive - Recruiting
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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