A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D 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

CTIS2023-504581-29-00

Acronym

64407564MMY1001

Enrollment

291

Registered

2024-02-22

Start date

2018-04-26

Completion date

Unknown

Last updated

2025-12-22

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

Conditions

Multiple myeloma

Brief summary

Part 1 and Part 2: Frequency and type of DLT; frequency and severity of adverse events, serious adverse events, and laboratory abnormalities, Part 3: ORR (PR or better) as defined by the IMWG criteria based on review by the IRC, Occurrence and severity of TEAEs, serious TEAEs, adverse events of clinical interest, and ORR [PR or better], DOR, VGPR or better/CR or better/sCR, TTR, PFS, and OS.

Interventions

DRUGJNJ-64407564

DRUGRoActemra 20 mg/mL concentrate for solution for infusion

DRUGTyenne 20 mg/ml concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1 and Part 2: Frequency and type of DLT; frequency and severity of adverse events, serious adverse events, and laboratory abnormalities, Part 3: ORR (PR or better) as defined by the IMWG criteria based on review by the IRC, Occurrence and severity of TEAEs, serious TEAEs, adverse events of clinical interest, and ORR [PR or better], DOR, VGPR or better/CR or better/sCR, TTR, PFS, and OS.	—

Countries

Belgium, France, Germany, Netherlands, Poland, Spain

Outcome results

None listed

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