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NCT03145181 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1 study of Hematological Malignancies, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 1
- Development phase
- 302
- Enrollment target
- 13
- Study locations
NCT03145181 is a Phase 1 study of Hematological Malignancies that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 302 participants, below the 758-participant average among 16 other Hematological Malignancies trials with a reported enrollment target (60% lower). The trial reports 13 study locations across 6 states.
The verdict
NCT03145181, a Phase 1 study of Hematological Malignancies, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 302 participants
- Enrollment target
- 13
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Teclistamab (IV)
- DRUG Teclistamab(SC)
Study Locations (13)
Other
- Hospices Civils de Lyon HCL - Lyon
- CHRU Tours Hopital Bretonneau - Tours
- VU Medisch Centrum - Amsterdam
- Hosp. Univ. Germans Trias I Pujol - Badalona
- Hosp Clinic de Barcelona - Barcelona
- Clinica Univ. de Navarra - Pamplona
- Hosp Clinico Univ de Salamanca - Salamanca
- Haematology Centre, R 51 - Stockholm
California
- City of Hope - Duarte
Colorado
- Colorado Blood Cancer Institute - Denver
New York
- Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects - New York
North Carolina
- Levine Cancer Institute - Charlotte
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2017-05-16 |
| Est. Completion | 2027-05-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03145181
The ClinicalTrials.gov registry entry for NCT03145181 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 758-participant average among 16 other Hematological Malignancies trials with a reported enrollment target (60% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hematological Malignancies appearing as the primary indexed condition, and to 2 interventions - of which Teclistamab (IV) is the first listed.
NCT03145181 reports 13 study locations spanning 6 distinct geographic areas - top geographies include Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT03145181 about?
NCT03145181 is a clinical study titled "Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma". 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.
What is the current status of trial NCT03145181?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 302 participants. The study started on 2017-05-16. Estimated completion is 2027-05-28.
What conditions does trial NCT03145181 study?
This clinical trial studies the following conditions: Hematological Malignancies.
What interventions are being tested in trial NCT03145181?
The interventions under investigation include: Teclistamab (IV) (DRUG), Teclistamab(SC) (DRUG).
Who is sponsoring clinical trial NCT03145181?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03145181 being conducted?
This trial has 13 study locations across California, Colorado, New York, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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