A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma

Titre officiel

A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Subjects With Multiple Myeloma

Sommaire:

The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab) and to characterize the safety of each RP2D for selected treatment combinations.

Description de l'essai

Primary Outcome:

  • Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
  • Part 1: Number of Participants With Dose Limiting Toxicity by Severity
  • Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
  • Part 2: Number of Participants With Adverse Events and SAEs by Severity
Secondary Outcome:
  • Serum Concentration of Daratumumab
  • Serum Concentration of Talquetamab
  • Serum Concentration of Teclistamab
  • Biomarker Assessment of Daratumumab
  • Biomarker Assessment of Talquetamab
  • Biomarker Assessment of Teclistamab
  • Number of Participants With Anti-Drug Antibodies to Daratumumab
  • Number of Participants With Anti-Drug Antibodies to Talquetamab
  • Number of Participants With Anti-Drug Antibodies to Teclistamab
  • Overall Response Rate (ORR)
  • Clinical Benefit Rate
  • Duration of Response (DOR)
  • Time to Response
Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions, increased susceptibility to infections, hypercalcemia, and renal failure. Overall rationale of study is that daratumumab in combination with talquetamab or teclistamab may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. Daratumumab is human immunoglobulin G1 kappa monoclonal antibody (IgG1k) that binds with high affinity to a unique epitope on cluster of differentiation 38 (CD38) in a variety of hematological malignancies including multiple myeloma. Talquetamab and teclistamab are bispecific T cell redirection antibodies. Talquetamab binds to cluster of differentiation 3 (CD3) receptor complex on T cells and to G protein-coupled receptor family C group 5-member D (GPRC5D), a 7-transmembrane receptor protein on plasma cells and teclistamab binds to human and cynomolgus-CD3 and B cell maturation antigen (BCMA). Purpose of study is to evaluate safety of daratumumab in combination with talquetamab and teclistamab, and to evaluate preliminary antitumour activity of each combination. Study consists of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion) and a post treatment follow-up period (after end of treatment and up to 16 weeks after last dose. End of study is defined as last study assessment for last participant in study. Total duration of study is approximately 2.4 years. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points. Participants safety will be monitored throughout study by Study Evaluation Team (SET). SET consists of members of sponsor's study team and participating investigators.

Voir cet essai sur ClinicalTrials.gov

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