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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: Active Phase 1 study of Multiple Myeloma, sponsored by AbbVie.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A DLT is defined as a Treatment-emergent adverse event that is not unequivocally due to the participant's underlying malignancy or other extraneous cause.
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 |
What the registry record for NCT03933735 still lists
NCT03933735 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (60% lower).
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 lists 14 locations in 10 states (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.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03933735's enrollment target sits among peer trials
220 103rd of 438 higher than 335 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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