A Phase 1 interventional study of Teclistamab (IV) and Teclistamab(SC) in Hematological Malignancies, sponsored by Janssen Research & Development, LLC. Active, not recruiting at 13 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.
The study will be conducted in 2 parts, separately for IV and SC administration: dose escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of Teclistamab administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as 2 years after the last participant in Part 3 has received his or her initial dose of teclistamab. Study record NCT04557098 is Phase 2 part of this study and study record NCT03145181 is Phase 1 part of this study.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 302 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive Teclistamab intravenously (IV).
Drug: Teclistamab (IV)
Participants will receive Teclistamab IV.
Drug: Teclistamab (IV)
Participants will receive Teclistamab subcutaneously (SC).
Drug: Teclistamab(SC)
Participants will receive Teclistamab SC.
Drug: Teclistamab(SC)
Participants will receive IV infusion of Teclistamab.
Also known as: JNJ-64007957
Participants will receive SC injection of Teclistamab.
Also known as: JNJ-64007957
Dose Limiting Toxicity (DLT)
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.
Time frame: Up to Day 28
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Up to 7 years and 3 months
Teclistamab Serum Concentrations
Concentration assessment will be done to evaluate the effect of Teclistamab.
Time frame: Up to 8 weeks
Number of Participants with Teclistamab Antibodies
Antibodies to Teclistamab will be assessed to evaluate potential immunogenicity.
Time frame: Up to 8 weeks
Preliminary Antitumor Activity of Teclistamab at the RP2D(s) in Part 2
Preliminary antitumor activity of Teclistamab will be done using the International Myeloma Working Group (IMWG) response criteria.
Time frame: Up to End of Treatment (Approximately 91 days)
Biomarker Assessment
Biomarker assessment may be done to evaluate the effect of Teclistamab.
Time frame: Up to 8 weeks
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC