Clinical Trial: NCT03145181
Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | Janssen Research & Development, LLC |
| Information Provided By: | Janssen Research & Development, LLC |
| Last Update Posted: | 2026-09-25 |
Study Overview
Brief Summary
The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.
Official Title
64007957MMY1001: 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
Conditions
Hematological Malignancies
Intervention / Treatment
- Drug: Teclistamab (IV)
- Drug: Teclistamab(SC)
Other Study ID Numbers
- CR108206
- 64007957MMY1001
- 2016-002122-36
- 2023-503438-40-00
- 2023
- 2016
Start Date (Actual)
2017-05-16
Primary Completion Date (Actual)
2025-09-25
Study Completion Date (Estimated)
2027-08-24
Enrollment (Actual)
302
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Janssen Research & Development, LLC |
| Information Provided By: | Janssen Research & Development, LLC |
| Last Update Posted: | 2026-09-25 |
Study Overview
Brief Summary
The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.
Official Title
64007957MMY1001: 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
Conditions
Hematological Malignancies
Intervention / Treatment
- Drug: Teclistamab (IV)
- Drug: Teclistamab(SC)
Other Study ID Numbers
- CR108206
- 64007957MMY1001
- 2016-002122-36
- 2023-503438-40-00
- 2023
- 2016
Start Date (Actual)
2017-05-16
Primary Completion Date (Actual)
2025-09-25
Study Completion Date (Estimated)
2027-08-24
Enrollment (Actual)
302
Study Type
Interventional
Phase
Phase 1