A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503438-40-00

Acronym

64007957MMY1001

Enrollment

267

Registered

2024-07-31

Start date

2017-10-05

Completion date

Unknown

Last updated

2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory Multiple Myeloma

Brief summary

Part 1 (Dose Escalation): Frequency and type of DLT; Part 2 (Dose Expansion): Occurrence and severity of adverse events, serious adverse events, and laboratory values; Part 3 (Phase 2): ORR (PR or better) as defined by the IMWG criteria

Interventions

DRUGteclistamab

DRUGPrivigen 100 mg/ml solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1 (Dose Escalation): Frequency and type of DLT; Part 2 (Dose Expansion): Occurrence and severity of adverse events, serious adverse events, and laboratory values; Part 3 (Phase 2): ORR (PR or better) as defined by the IMWG criteria	—

Countries

Belgium, France, Germany, Italy, Netherlands, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026