RecruitingPhase 1NCT05652335

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

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

Sponsor

Janssen Research & Development, LLC

Enrollment

180 participants

Start Date

Nov 22, 2022

Study Type

INTERVENTIONAL

Conditions

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

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called JNJ-79635322 in people with relapsed or refractory multiple myeloma (a blood cancer) or a related condition called AL amyloidosis, where abnormal proteins build up and damage organs. This is an early-phase study testing safety and dosing. **You may be eligible if...** - You have been diagnosed with multiple myeloma that has come back or stopped responding to treatment, including prior therapy with specific drug classes - OR you have AL amyloidosis that has been previously treated **You may NOT be eligible if...** - You have not received prior required treatments - You have active serious infections or significant organ problems - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJNJ-79635322

JNJ-79635322 will be administered as SC injection.

Locations(29)

City of Hope

Duarte, California, United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

University of California San Francisco

San Francisco, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Icahn School of Medicine at Mt. Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

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

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

UZ Antwerpen

Edegem, Belgium

UZ Gent

Ghent, Belgium

CHU de Liege

Liège, Belgium

CHU Nantes

Nantes, France

CHU Lyon Sud

Pierre-Bénite, France

Chu Rennes Hopital Pontchaillou

Rennes, France

Institut Claudius Regaud

Toulouse, France

Japanese Red Cross Medical Center

Shibuya City, Japan

Osaka University Hospital

Suita-shi, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

VUMC Amsterdam

Amsterdam, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

UMC Utrecht

Utrecht, Netherlands

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp Clinico Univ de Salamanca

Salamanca, Spain

University College Hospital

London, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05652335

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