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

Active, enrolled Phase 1/Phase 2 Last updated 4 February 2026

What this trial tests

Phase 1/Phase 2 trial testing TNB-383B in Multiple Myeloma in 220 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 June 2019

Primary endpoint
1 May 2026

1 May 2026

Quick facts

Lead sponsor	AbbVie
Phase	Phase 1/Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	220
Start date	24 June 2019
Primary completion	1 May 2026
Estimated completion	1 May 2026
Sites	14 locations across United States, Germany

Drugs / interventions tested

• TNB-383B — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

AbbVie — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants with Dose-limiting toxicities (DLT)
  Time frame: Day 21
  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.
• Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
  Time frame: Up to 3 Years
  An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or signi
• Maximum Observed Plasma Concentration of TNB-383B (Cmax)
  Time frame: Week 12
  Cmax of TNB-383B.
• Time to Cmax of TNB-383B (Tmax)
  Time frame: Week 12
  Time to maximum plasma concentration (Tmax) of TNB-383B.
• Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUClast)
  Time frame: Week 12
  Area under the concentration versus time curve from time zero to the last measurable concentration of TNB-383B.
• Clearance (CL) of TNB-383B
  Time frame: Week 12
  Clearance is defined the volume of plasma cleared of the drug per unit time.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. B-cell maturation antigen (BCMA) in multiple myeloma: rationale for targeting and current therapeutic approaches.
   Shah N, Chari A, Scott E, Mezzi K, et al · · 2020 · cited 342× · PMID 32055000 · DOI 10.1038/s41375-020-0734-z
2. Bispecific Antibodies: From Research to Clinical Application.
   Ma J, Mo Y, Tang M, Shen J, et al · · 2021 · cited 199× · PMID 34025638 · DOI 10.3389/fimmu.2021.626616
3. The landscape of bispecific T cell engager in cancer treatment.
   Zhou S, Liu M, Ren F, Meng X, et al · · 2021 · cited 172× · PMID 34039409 · DOI 10.1186/s40364-021-00294-9
4. BCMA-targeted immunotherapy for multiple myeloma.
   Yu B, Jiang T, Liu D. · · 2020 · cited 165× · PMID 32943087 · DOI 10.1186/s13045-020-00962-7
5. Current landscape and future directions of bispecific antibodies in cancer immunotherapy.
   Wei J, Yang Y, Wang G, Liu M. · · 2022 · cited 127× · PMID 36389699 · DOI 10.3389/fimmu.2022.1035276
6. Monitoring, prophylaxis, and treatment of infections in patients with MM receiving bispecific antibody therapy: consensus recommendations from an expert panel.
   Raje N, Anderson K, Einsele H, Efebera Y, et al · · 2023 · cited 120× · PMID 37528088 · DOI 10.1038/s41408-023-00879-7
7. A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen × CD3 Bispecific T-Cell Redirecting Antibody, in Patients With Relapsed/Refractory Multiple Myeloma.
   D'Souza A, Shah N, Rodriguez C, Voorhees PM, et al · · 2022 · cited 111× · PMID 36029527 · DOI 10.1200/jco.22.01504
8. How to Train Your T Cells: Overcoming Immune Dysfunction in Multiple Myeloma.
   Cohen AD, Raje N, Fowler JA, Mezzi K, et al · · 2020 · cited 90× · PMID 31672768 · DOI 10.1158/1078-0432.ccr-19-2111