A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma (NCT03933735)
A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-383B, a Bispecific Antibody Targeting BCMA in Subjects With Relapsed or Refractory Multiple Myeloma
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California San Francisco (UCSF) - Parnassus Heights /ID# 238680 — San Francisco, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- University of California San Francisco (UCSF) - Parnassus Heights /ID# 238680 — San Francisco, California
- Tulane University School of Medicine /ID# 242322 — New Orleans, Louisiana
- Mayo Clinic - Rochester /ID# 238683 — Rochester, Minnesota
- Washington University-School of Medicine /ID# 238681 — St Louis, Missouri
- Mt Sinai /ID# 242317 — New York, New York
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244831 — New York, New York
- University of North Carolina /ID# 238685 — Chapel Hill, North Carolina
- Atrium Health Levine Cancer Institute /ID# 238786 — Charlotte, North Carolina
- Atrium Health Wake Forest Baptist Medical Center /ID# 238787 — Winston-Salem, North Carolina
- Wisconsin Medical Center /ID# 238684 — Milwaukee, Wisconsin
- Universitaetsklinikum Koeln /ID# 239676 — Cologne, North Rhine-Westphalia
- Duplicate_Universitaetsklinikum Muenster /ID# 239637 — Münster, North Rhine-Westphalia
- Universitaetsklinikum Carl Gustav Carus Dresden /ID# 239638 — Dresden, Saxony
- Universitaetsklinikum Hamburg-Eppendorf /ID# 239636 — Hamburg,
📞 Contact the Study Coordinator
Phone: (877) 827-3222
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.