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Clinical Trial NCT03145181 (MajesTEC-1) for Hematological Malignancies is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1) Phase 1, Phase 2 302 Dose Escalation
Clinical Trial NCT03145181 (MajesTEC-1) is designed to study Treatment for Hematological Malignancies. It is a Phase 1 Phase 2 interventional study that is active, not recruiting, having started on 16 May 2017, with plans to enroll 302 participants. Led by Janssen Research & Development, LLC, it is expected to complete by 28 May 2027. The latest data from ClinicalTrials.gov was last updated on 12 March 2026.
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.
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 Cooperativ...Show More
Official Title
A Phase 1, 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 MalignanciesPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- MajesTEC-1
- CR108206
- 64007957MMY1001 (Other Identifier) (Janssen Research & Development, LLC)
- 2016-002122-36 (EudraCT Number)
- 2023-503438-40-00 (Registry Identifier) (EUCT number)
NCT ID Number
Start Date (Actual)
2017-05-16
Last Update Posted
2026-03-12
Completion Date (Estimated)
2027-05-28
Enrollment (Estimated)
302
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPart 1: Dose Escalation (IV) Participants will receive Teclistamab intravenously (IV). | Teclistamab (IV) Participants will receive IV infusion of Teclistamab. |
ExperimentalPart 2: Dose Expansion (IV) Participants will receive Teclistamab IV. | Teclistamab (IV) Participants will receive IV infusion of Teclistamab. |
ExperimentalPart 1: Dose Escalation (SC) Participants will receive Teclistamab subcutaneously (SC). | Teclistamab(SC) Participants will receive SC injection of Teclistamab. |
ExperimentalPart 2: Dose Expansion (SC) Participants will receive Teclistamab SC. | Teclistamab(SC) Participants will receive SC injection of Teclistamab. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | Up to 7 years and 3 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Teclistamab Serum Concentrations | Concentration assessment will be done to evaluate the effect of Teclistamab. | Up to 8 weeks |
Number of Participants with Teclistamab Antibodies | Antibodies to Teclistamab will be assessed to evaluate potential immunogenicity. | 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. | Up to End of Treatment (Approximately 91 days) |
Biomarker Assessment | Biomarker assessment may be done to evaluate the effect of Teclistamab. | Up to 8 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Janssen Research & Development, LLCNo contact data.
13 Study Locations in 5 Countries
California
City of Hope, Duarte, California, 91010, United States
Colorado
Colorado Blood Cancer Institute, Denver, Colorado, 80218, United States
New York
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects, New York, New York, 10029, United States
North Carolina
Levine Cancer Institute, Charlotte, North Carolina, 28204, United States
Pennsylvania
University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States
Hospices Civils de Lyon HCL, Lyon, 69002, France
CHRU Tours Hopital Bretonneau, Tours, 37044, France
VU Medisch Centrum, Amsterdam, 1081 HV, Netherlands
Hosp. Univ. Germans Trias I Pujol, Badalona, 08916, Spain
Hosp Clinic de Barcelona, Barcelona, 08036, Spain
Clinica Univ. de Navarra, Pamplona, 31008, Spain
Hosp Clinico Univ de Salamanca, Salamanca, 37007, Spain
Haematology Centre, R 51, Stockholm, SE-141 86, Sweden