Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

Hematological Malignancies Clinical Trial

— MajesTEC-1  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03145181
• Other study ID #: CR108206
• Secondary ID: 2016-002122-3664
• Status: Recruiting
• Phase: Phase 1
• Start date: May 16, 2017
• Est. completion date: July 22, 2026

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 282
• Est. completion date: July 22, 2026
• Est. primary completion date: November 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancies
• Multiple Myeloma

Intervention

Drug:
• Teclistamab (IV)
Participants will receive IV infusion of Teclistamab.
• Teclistamab(SC)
Participants will receive SC injection of Teclistamab.

Locations

Country	Name	City	State
France	Centre hospitalier Lyon-Sud	Pierre Benite cedex
France	CHRU Tours Hopital Bretonneau	Tours
Netherlands	VU Medisch Centrum	Amsterdam
Spain	Hosp. Univ. Germans Trias I Pujol	Badalona
Spain	Hosp Clinic de Barcelona	Barcelona
Spain	Clinica Univ. de Navarra	Pamplona
Spain	Hosp Clinico Univ de Salamanca	Salamanca
Sweden	Haematology Centre, R 51	Stockholm
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	City of Hope	Duarte	California
United States	Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  France,  Netherlands,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Teclistamab Serum Concentrations	Concentration assessment will be done to evaluate the effect of Teclistamab.	Up to 8 weeks
Secondary	Number of Participants with Teclistamab Antibodies	Antibodies to Teclistamab will be assessed to evaluate potential immunogenicity.	Up to 8 weeks
Secondary	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)
Secondary	Biomarker Assessment	Biomarker assessment may be done to evaluate the effect of Teclistamab.	Up to 8 weeks

External Links

•   A Study of Teclistamab, in Participants With Relapsed or Refractory Multiple Myeloma