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

Part of paid clinical trials in Duarte, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05652335
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JNJ-79635322 — DRUG
    JNJ-79635322 will be administered as SC injection.

Study Details

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).

Key Dates

First listed
Dec 15, 2022
Start date
Nov 22, 2022
Status verified
Jul 2026
Primary completion
Apr 19, 2027
Completion
Aug 28, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation
    Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.
  • Experimental: Part 2: Dose Expansion
    Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.

Primary Outcome Measure

Part 1: Number of Participants with Dose-limiting Toxicity (DLT) [ Time Frame: Up to 2 years 5 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
City of Hope Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618-
University of California San FranciscoSan FranciscoCalifornia94143-
Colorado Blood Cancer InstituteDenverColorado80218-
Icahn School of Medicine at Mt. SinaiNew YorkNew York10029-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Levine Cancer InstituteCharlotteNorth Carolina28001-
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CACity of Hope Orange County Lennar Foundation Cancer Center· Irvine, CAUniversity of California San Francisco· San Francisco, CAColorado Blood Cancer Institute· Denver, COIcahn School of Medicine at Mt. Sinai· New York, NYMemorial Sloan Kettering Cancer Center· New York, NY

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