Glofitamab in B-NHL Using Mid-Therapy Intratumoral Transcriptomics
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJoshua Brody
About this trial
This trial will enroll patients with relapsed/refractory DLBCL and MCL, with the opportunity to receive single-agent glofitamab as early as the second-line. Patients will have superficially accessible disease to enable core-needle biopsy prior to therapy initiation, and on cycle 1 day 15 and cycle 2 day 1 of therapy administration to enable high throughput molecular profiling of disease and immune dynamics while on treatment.
Eligibility criteria
Qualifiers
Patients with pathologically confirmed diagnosis of aggressive CD20(+) B-NHL,
including DLBCL and MCL.
Stage II, III or IV by Ann Arbor Classification.
Superficially accessible lesion for core-needle biopsy, e.g. cervical, axillary,
Disqualifiers
Contraindication to any of the individual components of glofitamab or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Any prior treatment with a BsAb targeting CD3 and CD20
Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation
Prior treatment with systemic immunotherapeutic agents, including but not limited to, radio-immuno-conjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (mAbs) (e.g., anti-cytotoxic T lymphocyte associated protein 4, anti-PD-1, and anti-PD-L1) within 4 weeks or five half-lives of the drug, whichever is shorter
Trial design
Treatments tested in this trial
- Glofitamab
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Joshua Brody
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov