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NCT03933735 · ClinicalTrials.gov registry record · Phase 1
A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1 study of Multiple Myeloma, sponsored by AbbVie.
- Active
- Registry status
- Phase 1
- Development phase
- 220
- Enrollment target
- 14
- Study locations
NCT03933735 is a Phase 1 study of Multiple Myeloma that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 220 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (60% lower). The trial reports 14 study locations across 10 states.
The verdict
NCT03933735, a Phase 1 study of Multiple Myeloma, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 220 participants
- Enrollment target
- 14
- Study locations
Study Summary
This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of TNB-383B, a BCMA x CD3 T-cell engaging bispecific antibody, in participants with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 4 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B), Monotherapy once every 4 weeks (Q4W) dosing (Arm E), Monotherapy once every 3 weeks (Q3W) dosing (Arm F). Arm A will evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of escalating doses of single-agent TNB-383B, administered Q3W, in approximately 73 participants. Once the maximum tolerated dose (MTD) or recommended phase 2 dose, (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 48 participants each. Dose A will be evaluated as a monotherapy Q4W, in Arm E to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 20 participants. Dose C will be evaluated as a monotherapy, in Arm F to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 25 participants.
Conditions Studied
Interventions
- DRUG TNB-383B
Study Locations (14)
North Carolina
- University of North Carolina /ID# 238685 - Chapel Hill
- Atrium Health Levine Cancer Institute /ID# 238786 - Charlotte
- Atrium Health Wake Forest Baptist Medical Center /ID# 238787 - Winston-Salem
New York
- Mt Sinai /ID# 242317 - New York
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244831 - New York
North Rhine-Westphalia
- Universitaetsklinikum Koeln /ID# 239676 - Cologne
- Duplicate_Universitaetsklinikum Muenster /ID# 239637 - Münster
California
- University of California San Francisco (UCSF) - Parnassus Heights /ID# 238680 - San Francisco
Louisiana
- Tulane University School of Medicine /ID# 242322 - New Orleans
Minnesota
- Mayo Clinic - Rochester /ID# 238683 - Rochester
Missouri
- Washington University-School of Medicine /ID# 238681 - St Louis
Wisconsin
- Wisconsin Medical Center /ID# 238684 - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03933735
The ClinicalTrials.gov registry entry for NCT03933735 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (60% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which TNB-383B is the first listed.
NCT03933735 reports 14 study locations spanning 10 distinct geographic areas - top geographies include North Carolina, New York, North Rhine-Westphalia.
Frequently Asked Questions
What is clinical trial NCT03933735 about?
NCT03933735 is a clinical study titled "A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma". This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of TNB-383B, a BCMA x CD3 T-cell engaging bispecific antibody, in participants with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 4 portions, ...
What is the current status of trial NCT03933735?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2019-06-24. Estimated completion is 2026-05.
What conditions does trial NCT03933735 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT03933735?
The interventions under investigation include: TNB-383B (DRUG).
Who is sponsoring clinical trial NCT03933735?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03933735 being conducted?
This trial has 14 study locations across California, Louisiana, Minnesota, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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