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

Janssen-Cilag International NV0 sites473 target enrollmentJuly 30, 2020

ConditionsRelapsed or Refractory Multiple Myeloma MedDRA version: 20.0Level: HLGTClassification code 10005330Term: Blood and lymphatic system disorders congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disorders Therapeutic area: Diseases [C] - Cancer [C04]

DrugsTECVAYLI

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed or Refractory Multiple Myeloma
Sponsor: Janssen-Cilag International NV
Enrollment: 473
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 30, 2020

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Janssen-Cilag International NV

Eligibility Criteria

Inclusion Criteria

•1\. \=18 years of age.
•2\. Documented diagnosis of MM according to IMWG diagnostic criteria.
•3\. Part 1 and Part 2
•Measurable MM that is relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory MM or be intolerant of those established MM therapies, and a candidate for teclistamab treatment in the opinion of the treating physician. Prior lines of therapy must include a PI, an IMiD and an anti\-CD38 monoclonal antibody in any order during the course of treatment. Subjects who could not tolerate a PI, IMiD, or an anti\-CD38 monoclonal antibody are allowed. In Part 2 (dose expansion), in addition to above criteria, MM must be measurable per current IMWG published guidelines by central lab assessment. If central lab assessment is not available, relevant local lab measurement must exceed the minimum required level by at least 25%.
•Measurable disease
•Cohort A and Cohort C: MM must be measurable by central lab assessment:
•\- Serum monoclonal paraprotein (M\-protein) level \=1\.0 g/dL or urine M\-protein level \=200 mg/24 hours; or
•\- Light chain MM without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) \=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio. If central lab assessments are not available, relevant local lab measurements must exceed the min required level by at least 25%.
•Prior treatment:
•\- Cohort A: Subjects must have 1\) received \=3 prior lines of therapy and 2\) previously received a PI, an IMiD, and an anti\-CD38 monoclonal

Exclusion Criteria

•1\. Prior treatment with any BCMA\-targeted therapy, with the exception of Cohort C in Part 3\.
•2\. 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 (eg, chimeric antigen receptor modified T cells, natural killer \[NK] cells) within 3 months
•\-Radiotherapy within 14 days or focal radiation within 7 days.
•3\. Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.