RecruitingPhase 1interventionalRules rewrite

Phase 1: testing JNJ-79635322 for Relapsed or Refractory Multiple Myeloma

Q: Is NCT05652335 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT05652335?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT05652335?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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 whether it is safe and how hard side effects are to live with of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).

Official registry: https://clinicaltrials.gov/study/NCT05652335 · Janssen Research & Development, LLC · enrollment listed as 180

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are JNJ-79635322. The registry lists allocation as randomized. 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 whether it is safe and how hard side effects are to live with of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).

They plan to enroll about 180 people at 29 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: JNJ-79635322

Primary outcome (registry wording): Part 1: Number of Participants with Dose-limiting Toxicity (DLT)

Who it is for (from inclusion criteria)

Ages 18 Years to any
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
Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
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

Who the registry excludes

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 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)

Public study contact (from the registry)

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

29 listed

City of Hope — Duarte, California (recruiting)
City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California (recruiting)
University of California San Francisco — San Francisco, California (recruiting)
Colorado Blood Cancer Institute — Denver, Colorado (recruiting)
Icahn School of Medicine at Mt. Sinai — New York, New York (recruiting)
Memorial Sloan Kettering Cancer Center — New York, New York (recruiting)
Levine Cancer Institute — Charlotte, North Carolina (recruiting)
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania (recruiting)
MD Anderson Cancer Center — Houston, Texas (recruiting)

+ 20 sites outside the US on the same record

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FAQ about this NCT record

Is NCT05652335 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05652335?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05652335?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary