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A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

NCT04557098•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria
•Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
•Measurable disease: Cohort A and Cohort C: Multiple myeloma must be measurable by central laboratory assessment
•A female participant of childbearing potential must have a negative pregnancy test at screening
•Willing and able to adhere to the prohibitions and restrictions specified in this protocol
•Cohort A: received at least \>=3 prior lines of therapy and previously received a PI, an IMiD and an anti-CD38 monoclonal antibody; Cohort C: received \>= 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC)

Exclusion Criteria

•Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
•The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (\<=) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction \<= 6 m, stage III-IV congestive heart failure, etc)
•Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3
•Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug
•Toxicities from previous anticancer therapies that have not resolved to baseline or to \<= grade 1 (except for alopecia or peripheral neuropathy)
•Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
•Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma (MM)
•Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma with exceptions are: 1) Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured 2) Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. 3) Noninvasive cervical cancer treated within the last 24 months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5) Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. 6) Malignancy that is considered cured with minimal risk of recurrence
•Prior allogenic stem cell transplant \<=6 months
•Prior autologous stem cell transplant \<=12 weeks
+1 more criteria

Locations (51)

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope

Duarte, California, United States

University of California San Francisco

San Francisco, California, United States

Stanford University Medical Center

Stanford, California, United States

Winship Cancer Institute Emory University

Atlanta, Georgia, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects

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

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

September 17, 2020

Primary Completion Date

August 26, 2025

Completion Date

May 28, 2027

Last Updated

March 12, 2026

Enrollment

194

ACTUAL participants

Conditions

Hematological Malignancies

Interventions

Teclistamab

DRUG

Study of MGUS, Smoldering Myeloma, Early MDS and CLL to Assess Molecular Events of Progression and Clinical Outcome

NCT02269592

Monoclonal Gammopathy of Undetermined Significance (MGUS)Myelodysplastic Syndromes+6 more

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RECRUITING

18F-Pentixafor PET in Hematologic Malignancies

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Hematological Malignancies

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Inclusion Criteria

Exclusion Criteria

Study of MGUS, Smoldering Myeloma, Early MDS and CLL to Assess Molecular Events of Progression and Clinical Outcome

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