Clinical trial · no report yet · Phase 1
MajesTEC-1
Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
- NCT03145181 ↗
- Active, not recruiting
- Janssen Research & Development, LLC
- Deep
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| YouTube | 109 | |
| X threads | 70 | |
| Podcasts | 58 | |
| Bluesky threads | 1 |
The trial
ClinicalTrials.gov- 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
- Phase
- Phase 1
- Status
- Active, not recruiting
- Conditions
- Hematological Malignancies
- Interventions
- Teclistamab (IV); Teclistamab(SC)
- Arms
- Part 1: Dose Escalation (IV) · Experimental
- Part 2: Dose Expansion (IV) · Experimental
- Part 1: Dose Escalation (SC) · Experimental
- Part 2: Dose Expansion (SC) · Experimental
- Enrollment
- 302
- Primary outcomes
- Dose Limiting Toxicity (DLT)
- Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
- Sponsor
- Janssen Research & Development, LLC
- Start
- May 16, 2017
- Primary completion
- Sep 25, 2025
- Results posted
- No
- Registry record
- NCT03145181 · updated Sep 25, 2026
Publications
linked from the registry- Carde NAQ, Niu J, Guo Y, Zhou J, Qiu X, Su Y, Perez-Ruixo C, Vishwamitra D, Hodin C, Stephenson T, Zuppa A, Chastain K, Kobos R, Samtani MN, Wang W, Haddish-Berhane N, Van de Donk NWCJ, Garfall AL, Matous JV. Revised Recommendations for Restarting Teclistamab Following Dose Delays: Insights from the MajesTEC-1 Study on Clinical Safety, and from Simulated Pharmacokinetics and Cytokine Dynamics. Target Oncol. 2026 May;21(3):373-383. doi: 10.1007/s11523-026-01205-4. Epub 2026 Mar 26. PubMed 41886220
- Martin TG, Mateos MV, Yi JH, van de Donk NWCJ, Cai Z, Fu W, Garfall AL, Iida S, Jung SH, Kuroda Y, Niu T, Nooka AK, Min CK, Sidana S, Chastain K, Doyle M, Nishikawa K, Wang X, Song Y, Yamazaki H, Izumi Y, Zhuo J, Zhu A, Yoon DH, Du J, Ishida T. Efficacy and safety of teclistamab in triple-class exposed relapsed/refractory multiple myeloma: Pooled findings from three clinical cohorts and a retrospective cohort. Cancer. 2026 Jan 1;132(1):e70237. doi: 10.1002/cncr.70237. PubMed 41485109
- Guo Y, Niu J, Carde NAQ, Wu L, Miao X, Hanson S, Su Y, Ruixo CP, Vishwamitra D, Chastain K, Samtani MN, Wang W, Haddish-Berhane N. Teclistamab Dosing in Responders: Modeling and Simulation Results from the MajesTEC-1 Study in Relapsed/Refractory Multiple Myeloma. Target Oncol. 2025 Jul;20(4):651-661. doi: 10.1007/s11523-025-01149-1. Epub 2025 May 7. PubMed 40332715
- Touzeau C, Krishnan AY, Moreau P, Perrot A, Usmani SZ, Manier S, Cavo M, Martinez Chamorro C, Nooka AK, Martin TG, Karlin L, Leleu X, Bahlis NJ, Besemer B, Pei L, Stein S, Wang Lin SX, Trancucci D, Verona RI, Girgis S, Miao X, Uhlar CM, Chastain K, Garfall AL. Efficacy and safety of teclistamab in patients with relapsed/refractory multiple myeloma after BCMA-targeting therapies. Blood. 2024 Dec 5;144(23):2375-2388. doi: 10.1182/blood.2023023616. PubMed 39172760
- Moreau P, Mateos MV, Gonzalez Garcia ME, Einsele H, De Stefano V, Karlin L, Lindsey-Hill J, Besemer B, Vincent L, Kirkpatrick S, Delforge M, Perrot A, van de Donk NWCJ, Pawlyn C, Manier S, Leleu X, Martinez-Lopez J, Ghilotti F, Diels J, Morano R, Albrecht C, Strulev V, Haddad I, Pei L, Kobos R, Smit J, Slavcev M, Marshall A, Weisel K. Comparative Effectiveness of Teclistamab Versus Real-World Physician's Choice of Therapy in LocoMMotion and MoMMent in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Feb;41(2):696-715. doi: 10.1007/s12325-023-02738-0. Epub 2023 Dec 19. PubMed 38110653
- Martin TG, Moreau P, Usmani SZ, Garfall A, Mateos MV, San-Miguel JF, Oriol A, Nooka AK, Rosinol L, Chari A, Karlin L, Krishnan A, Bahlis N, Popat R, Besemer B, Martinez-Lopez J, Delforge M, Trancucci D, Pei L, Kobos R, Fastenau J, Gries KS, van de Donk NWCJ. Teclistamab Improves Patient-Reported Symptoms and Health-Related Quality of Life in Relapsed or Refractory Multiple Myeloma: Results From the Phase II MajesTEC-1 Study. Clin Lymphoma Myeloma Leuk. 2024 Mar;24(3):194-202. doi: 10.1016/j.clml.2023.11.001. Epub 2023 Nov 14. PubMed 38052709
- Nooka AK, Rodriguez C, Mateos MV, Manier S, Chastain K, Banerjee A, Kobos R, Qi K, Verona R, Doyle M, Martin TG, van de Donk NWCJ. Incidence, timing, and management of infections in patients receiving teclistamab for the treatment of relapsed/refractory multiple myeloma in the MajesTEC-1 study. Cancer. 2024 Mar 15;130(6):886-900. doi: 10.1002/cncr.35107. Epub 2023 Nov 14. PubMed 37960969
- Miao X, Wu LS, Lin SXW, Xu Y, Chen Y, Iwaki Y, Kobos R, Stephenson T, Kemmerer K, Uhlar CM, Banerjee A, Goldberg JD, Trancucci D, Apte A, Verona R, Pei L, Desai R, Hickey K, Su Y, Ouellet D, Samtani MN, Guo Y, Garfall AL, Krishnan A, Usmani SZ, Zhou H, Girgis S. Population Pharmacokinetics and Exposure-Response with Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma: Results From MajesTEC-1. Target Oncol. 2023 Sep;18(5):667-684. doi: 10.1007/s11523-023-00989-z. Epub 2023 Sep 15. PubMed 37713090
- Moreau P, van de Donk NW, Nahi H, Oriol A, Nooka AK, Martin T, Rosinol L, Karlin L, Benboubker L, Mateos MV, Popat R, Martinez-Lopez J, Sidana S, Delforge M, Pei L, Trancucci D, Olyslager Y, Uhlar C, Stephenson T, Rampelbergh RV, Banerjee A, Kobos R, Usmani SZ. Plain language summary of the MajesTEC-1 study of teclistamab for the treatment of people with relapsed or refractory multiple myeloma. Future Oncol. 2023 Apr;19(12):811-818. doi: 10.2217/fon-2023-0171. Epub 2023 May 3. PubMed 37132225
- Martin TG, Mateos MV, Nooka A, Banerjee A, Kobos R, Pei L, Qi M, Verona R, Doyle M, Smit J, Sun W, Trancucci D, Uhlar C, van de Donk NWCJ, Rodriguez C. Detailed overview of incidence and management of cytokine release syndrome observed with teclistamab in the MajesTEC-1 study of patients with relapsed/refractory multiple myeloma. Cancer. 2023 Jul 1;129(13):2035-2046. doi: 10.1002/cncr.34756. Epub 2023 Mar 29. PubMed 36991547
- Girgis S, Lin SXW, Pillarisetti K, Banerjee A, Stephenson T, Ma X, Shetty S, Yang TY, Hilder BW, Jiao Q, Hanna B, Adams HC 3rd, Sun YN, Sharma A, Smit J, Infante JR, Goldberg JD, Elsayed Y. Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma. Target Oncol. 2022 Jul;17(4):433-439. doi: 10.1007/s11523-022-00893-y. Epub 2022 Jun 24. PubMed 35749004
- Moreau P, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Nooka AK, Martin T, Rosinol L, Chari A, Karlin L, Benboubker L, Mateos MV, Bahlis N, Popat R, Besemer B, Martinez-Lopez J, Sidana S, Delforge M, Pei L, Trancucci D, Verona R, Girgis S, Lin SXW, Olyslager Y, Jaffe M, Uhlar C, Stephenson T, Van Rampelbergh R, Banerjee A, Goldberg JD, Kobos R, Krishnan A, Usmani SZ. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022 Aug 11;387(6):495-505. doi: 10.1056/NEJMoa2203478. Epub 2022 Jun 5. PubMed 35661166
- Usmani SZ, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Rosinol L, Chari A, Bhutani M, Karlin L, Benboubker L, Pei L, Verona R, Girgis S, Stephenson T, Elsayed Y, Infante J, Goldberg JD, Banerjee A, Mateos MV, Krishnan A. Teclistamab, a B-cell maturation antigen x CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. Lancet. 2021 Aug 21;398(10301):665-674. doi: 10.1016/S0140-6736(21)01338-6. Epub 2021 Aug 10. PubMed 34388396
- Pillarisetti K, Powers G, Luistro L, Babich A, Baldwin E, Li Y, Zhang X, Mendonca M, Majewski N, Nanjunda R, Chin D, Packman K, Elsayed Y, Attar R, Gaudet F. Teclistamab is an active T cell-redirecting bispecific antibody against B-cell maturation antigen for multiple myeloma. Blood Adv. 2020 Sep 22;4(18):4538-4549. doi: 10.1182/bloodadvances.2020002393. PubMed 32956453