Hematological MalignanciesPhase 1MajesTEC-1NCT03145181
Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing Teclistamab (IV) and Teclistamab(SC) in people with Hematological Malignancies, run by Janssen Research & Development, LLC at 13 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- Teclistamab (IV) and Teclistamab(SC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 16 May 2017to 24 Aug 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Measurable multiple myeloma that is relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory multiple myeloma or be intolerant of those established multiple myeloma therapies, and a candidate for Teclistamab treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory drug and anti-CD38 monoclonal antibody in any order during the course of treatment. Participants who could not tolerate a proteasome inhibitor or immunomodulatory drugs and an anti-CD38 monoclonal antibody are allowed
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Female participants of childbearing potential must use acceptable method of contraception
- Participants must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease
Who cannot join
- Prior treatment with any B cell maturation antigen (BCMA) targeted therapy
- Prior antitumor therapy as follows, before the first dose of study drug: Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less; Monoclonal antibody treatment for multiple myeloma within 21 days; Cytotoxic therapy within 21 days; Proteasome inhibitor therapy within 14 days; Immunomodulatory agent therapy within 7 days; Gene modified adoptive cell therapy (example, chimeric antigen receptor modified T cells, natural killer [NK] cells) within 3 months; Radiotherapy within 14 days or focal radiation within 7 days
- Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
- Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
United States5 sites
Levine Cancer Institute
Charlotte, North Carolina, 28204
Colorado Blood Cancer Institute
Denver, Colorado, 80218
City of Hope
Duarte, California, 91010
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
New York, New York, 10029
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Spain4 sites
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
Hosp Clinic de Barcelona
Barcelona, 08036
Clinica Univ. de Navarra
Pamplona, 31008
Hosp Clinico Univ de Salamanca
Salamanca, 37007
France2 sites
Hospices Civils de Lyon HCL
Lyon, 69002
CHRU Tours Hopital Bretonneau
Tours, 37044
About this study
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
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.
Read the detailed description
The study will be conducted in 2 parts, separately for IV and SC administration: dose escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of Teclistamab administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as 2 years after the last participant in Part 3 has received his or her initial dose of teclistamab. Study record NCT04557098 is Phase 2 part of this study and study record NCT03145181 is Phase 1 part of this study.
- Conditions
- Hematological Malignancies
- Being tested
- Teclistamab (IV), Teclistamab(SC)
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teclistamab (IV)Drug
Also called JNJ-64007957
Participants will receive IV infusion of Teclistamab.
Teclistamab(SC)Drug
Also called JNJ-64007957
Participants will receive SC injection of Teclistamab.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation (IV) | Experimental | Participants will receive Teclistamab intravenously (IV). Receives: Drug: Teclistamab (IV) |
| Part 2: Dose Expansion (IV) | Experimental | Participants will receive Teclistamab IV. Receives: Drug: Teclistamab (IV) |
| Part 1: Dose Escalation (SC) | Experimental | Participants will receive Teclistamab subcutaneously (SC). Receives: Drug: Teclistamab(SC) |
| Part 2: Dose Expansion (SC) | Experimental | Participants will receive Teclistamab SC. Receives: Drug: Teclistamab(SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.
Measured: Up to Day 28
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measured: Up to 7 years and 3 months
Secondary outcomes (4)
Teclistamab Serum Concentrations
Concentration assessment will be done to evaluate the effect of Teclistamab.
Measured: Up to 8 weeks
Number of Participants with Teclistamab Antibodies
Antibodies to Teclistamab will be assessed to evaluate potential immunogenicity.
Measured: Up to 8 weeks
Preliminary Antitumor Activity of Teclistamab at the RP2D(s) in Part 2
Preliminary antitumor activity of Teclistamab will be done using the International Myeloma Working Group (IMWG) response criteria.
Measured: Up to End of Treatment (Approximately 91 days)
Biomarker Assessment
Biomarker assessment may be done to evaluate the effect of Teclistamab.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start16 May 2017
- Primary completion25 Sep 2025
- Study completion24 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145181
- Sponsor's protocol ID
- CR108206
- Other IDs
- 64007957MMY1001, 2016-002122-36, 2023-503438-40-00, 2023, 2016
- Acronym
- MajesTEC-1
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2017
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Publications
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 41886220Martin 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 41485109Guo 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 40332715Touzeau 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 39172760Moreau 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 38110653Martin 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 38052709Nooka 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 37960969Miao 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 37713090Moreau 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 37132225Martin 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 36991547Girgis 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 35749004Moreau 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 35661166Usmani 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 34388396Pillarisetti 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