A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma

Study Purpose

The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Cohort A: Received a minimum of 1 to a maximum of 3 prior lines of therapy including a proteasome inhibitor (PI) and immunomodulatory therapy (IMiD), and lenalidomide refractory per International Myeloma Working Group (IMWG) guidelines.
  • - Cohort B: Received one line of prior therapy including a PI and an IMiD, and disease progression per IMWG criteria less than or equal to (<=) 12 months after treatment with autologous stem cell transplantation (ASCT) or <=12 months from the start of anti-myeloma therapy for participants who have not had an ASCT.
  • - Cohort C: Previously treated with a PI, an IMiD, an anti-CD38 monoclonal antibody and B-cell maturation antigen (BCMA)-directed therapy.
  • - Cohort D: Newly diagnosed multiple myeloma per IMWG with a history of 4 to 8 total cycles of initial therapy, including induction, high-dose therapy, and ASCT with or without consolidation.
  • - Cohort E: Have newly diagnosed multiple myeloma without prior therapy (one cycle of prior therapy before enrollment is acceptable) and classified as high risk defined as either: 1) International Staging System (ISS) stage III criteria, Beta 2 microglobulin greater than or equal to (>=) 5.5 milligram per liter (mg/L) (via local or central laboratory assessment) or 2) high risk cytogenetic features del(17/17p), t (14;16), t(14;20), 1q amplification (at least 4 total copies) in at least 20 percent (%) of the total plasma cell population.
  • - Cohort F: - Participant must have a documented efficacy response of very good partial response (VGPR) or better, without progressive disease prior to enrollment, as assessed per IMWG 2016 criteria.
  • - Received initial therapy as specified below.
The dose/schedule of cycles administered will be as per standard of care. It is acceptable for up to 1 cycle of the protocol-specified regimens to be missing one of the listed agents (example, held due to toxicity). Acceptable combinations include: At least 5 to 8 cycles of initial therapy with daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd). The dose/schedule of cycles administered will be as per standard of care or; at least 4 to 8 cycles of initial therapy with daratumumab, lenalidomide and dexamethasone (D-Rd) or; at least 4 to 8 cycles of initial therapy with a carfilzomib-based triplet or quadruplet regimen.
  • - Cohorts A, B, C, E: - Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours.
  • - Light chain multiple myeloma in whom only measurable disease is by serum free light chain (FLC) levels in the serum: Serum immunoglobulin FLC >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
  • - Cohort A: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole -body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria.
A minimum of one lesion with a bi-dimensional measurement of at least 1 centimeter (cm)*1 cm is required.
  • - Cohorts B, C: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria.
  • - Cohorts A, B, C, D, E, F: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1.

Exclusion Criteria:

  • - Cohorts A, B, D, F: Any therapy that is targeted to BCMA.
  • - Cohorts A, B, C, D, F: Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target.
  • - Cohorts A, B, C, D, F: - Ongoing toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
  • - Received a cumulative dose of corticosteroids equivalent to >=70 mg of prednisone within the 7 days (Cohort A, B, C, F) or 14 days (Cohort D) prior to apheresis.
  • - Serious underlying medical condition, such as (a) evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection; (b) active autoimmune disease or a history of autoimmune disease within 3 years; (c) overt clinical evidence of dementia or altered mental status; (d) any history of Parkinson's disease or other neurodegenerative disorder.
- Cohorts A, B, C, D, E, F: Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04133636
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, France, Germany, Israel, Netherlands, Saudi Arabia, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

Multiple myeloma is characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function. The main aim of the study is to determine the safety and efficacy of JNJ-68284528 in various clinical settings. JNJ-68284528 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA). The study comprises of a Screening Phase (less than or equal to [<=] 28 days prior to apheresis) followed by Apheresis (will occur upon enrollment); a Treatment Phase including a conditioning regimen followed by infusion of JNJ-68284528 and post-infusion assessments from Day 1 to Day 100 (participants who receive an infusion of JNJ-68284528 should continue all subsequent assessments); and a Post-treatment Phase (Day 101 and up to the end of each study cohort). Safety evaluations will include a review of adverse events, laboratory test results, vital sign measurements, physical examination findings (including neurologic examination), assessment of cardiac function, immune effector cell-associated encephalopathy (ICE) score, handwriting assessment, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status grade. Efficacy evaluations will include measurements of tumor burden/residual disease, myeloma proteins, bone marrow examinations, skeletal surveys, extramedullary plasmacytomas, and serum calcium corrected for albumin. For certain participants (those without measurable disease in serum or urine) efficacy will be assessed via imaging: positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI). The overall duration of the study is up to 2.5 years.

Arms & Interventions

Arms

Experimental: JNJ-68284528

Single group assignment-After lymphodepletion, JNJ-68284528 will be administered as single infusion to participants in cohort A (Progressive disease after 1-3 prior lines of therapy), cohort B (Early relapse after front-line), cohort C (Relapsed/refractory multiple myeloma after PI, IMiD, anti-CD38, and anti- BCMA therapy), cohort D (Less than CR after ASCT front-line therapy; some participants will be administered JNJ-68284528 followed by lenalidomide), cohort F (Newly diagnosed multiple myeloma [NDMM] with standard risk [international staging system {ISS} Stage I and II] and after initiation of therapy). Participants in cohort E (NDMM, transplant not planned, high risk disease) will first be administered with quadruplet induction regimen of daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd), followed by lymphodepletion and JNJ-68284528, followed by consolidation regimen of lenalidomide.

Interventions

Drug: - JNJ-68284528

Participants in cohort A,B,C, D, E and F will receive JNJ-68284528 intravenously.

Drug: - Lenalidomide

Some participants in cohort D and all participants in cohort E will also receive lenalidomide capsules orally.

Drug: - Daratumumab

Participants in cohort E will also receive daratumumab subcutaneous (SC) injection.

Drug: - Bortezomib

Participants in cohort E will also receive bortezomib subcutaneously.

Drug: - Dexamethasone

Participants in cohort E will also receive dexamethasone orally or intravenously.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City Of Hope Med Ctr, Duarte, California

Status

Withdrawn

Address

City Of Hope Med Ctr

Duarte, California, 91010

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94143

Moffitt Cancer Center, Tampa, Florida

Status

Recruiting

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30322

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

University of Chicago, Chicago, Illinois

Status

Recruiting

Address

University of Chicago

Chicago, Illinois, 60637

Indiana University, Indianapolis, Indiana

Status

Recruiting

Address

Indiana University

Indianapolis, Indiana, 46202

Johns Hopkins, Baltimore, Maryland

Status

Withdrawn

Address

Johns Hopkins

Baltimore, Maryland, 21287

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115

Mayo Clinic Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic Rochester

Rochester, Minnesota, 55905

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Hackensack University Medical Center, Hackensack, New Jersey

Status

Recruiting

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey

Status

Recruiting

Address

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

Montefiore Medical Center, Bronx, New York

Status

Recruiting

Address

Montefiore Medical Center

Bronx, New York, 10467

Roswell Park Cancer Institute, Buffalo, New York

Status

Recruiting

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

Mount Sinai Medical Center, New York, New York

Status

Recruiting

Address

Mount Sinai Medical Center

New York, New York, 10029

Memorial Sloan-Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065

Charlotte, North Carolina

Status

Recruiting

Address

Levine Cancer Institute, Carolinas HealthCare System

Charlotte, North Carolina, 28204

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

University of Pittsburgh, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232

Baylor University Medical Center, Dallas, Texas

Status

Withdrawn

Address

Baylor University Medical Center

Dallas, Texas, 75246

Houston, Texas

Status

Withdrawn

Address

University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030

Fred Hutchinson Cancer Center, Seattle, Washington

Status

Recruiting

Address

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

International Sites

Universitair Ziekenhuis - Antwerpen, Antwerp, Belgium

Status

Withdrawn

Address

Universitair Ziekenhuis - Antwerpen

Antwerp, , 2650

Institut Jules Bordet, Brussel, Belgium

Status

Withdrawn

Address

Institut Jules Bordet

Brussel, , 1000

UZ Gent, Gent, Belgium

Status

Recruiting

Address

UZ Gent

Gent, , 9000

UZ Leuven, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, , 3000

CHRU de Lille - Hôpital Claude Huriez, Lille, France

Status

Recruiting

Address

CHRU de Lille - Hôpital Claude Huriez

Lille, , 59037

C.H.U. Hotel Dieu - France, Nantes, France

Status

Recruiting

Address

C.H.U. Hotel Dieu - France

Nantes, , 44093

Hopital Saint-Louis, Paris cedex 10, France

Status

Recruiting

Address

Hopital Saint-Louis

Paris cedex 10, , 75475

Dresden, Germany

Status

Withdrawn

Address

Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

Dresden, , 01307

Universitaetsklinikum Hamburg Eppendorf, Hamburg, Germany

Status

Recruiting

Address

Universitaetsklinikum Hamburg Eppendorf

Hamburg, , 20246

Universitaetsklinikum Heidelberg, Heidelberg, Germany

Status

Not yet recruiting

Address

Universitaetsklinikum Heidelberg

Heidelberg, , 69120

Universitatsklinikum Leipzig, Leipzig, Germany

Status

Withdrawn

Address

Universitatsklinikum Leipzig

Leipzig, , 04103

Tübingen, Germany

Status

Withdrawn

Address

Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany

Tübingen, , 72076

Universitätsklinikum Würzburg, Würzburg, Germany

Status

Recruiting

Address

Universitätsklinikum Würzburg

Würzburg, , 97080

Sheba Medical Center Tel Hashomer, Ramat Gan, Israel

Status

Recruiting

Address

Sheba Medical Center Tel Hashomer

Ramat Gan, , 52621

Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel

Status

Recruiting

Address

Tel-Aviv Sourasky Medical Center

Tel-Aviv, , 64239

VU Medisch Centrum, Amsterdam, Netherlands

Status

Recruiting

Address

VU Medisch Centrum

Amsterdam, , 1081 HV

University Medical Center Groningen, Groningen, Netherlands

Status

Recruiting

Address

University Medical Center Groningen

Groningen, , 9713 GZ

Riyadh, Saudi Arabia

Status

Recruiting

Address

King Faisal Specialist Hospital & Research Center

Riyadh, , 11211

Clinica Univ. de Navarra, Pamplona, Spain

Status

Recruiting

Address

Clinica Univ. de Navarra

Pamplona, , 31008

Hosp. Clinico Univ. de Salamanca, Salamanca, Spain

Status

Recruiting

Address

Hosp. Clinico Univ. de Salamanca

Salamanca, , 37007