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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Glofitamab
Biological/VaccineGlofitamab is a bispecific T-cell-engaging antibody, designed to bind CD20 on B-cells, and CD3 on T-cells, bringing T-cells into close contact with malignant B-cells to trigger immune-mediated killing.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Participants with relapsed/refractory DLBCL or MCLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients with an increase of CD20(-) tumor cells >= 10 fold
Proportion of patients with an increase of CD20(-) tumor cells \>= 10-fold increase in proportion of CD20(-) lymphoma cells within 3 weeks of initiation of glofitamab therapy.
Time frame
within 3 weeks of glofitamab therapy initiationSecondary outcomes
1
Transcriptional changes in tumor cells
Transcriptional changes in tumor cells within 3 weeks of initiation of glofitamab therapy, defined as the fold-change of individual gene RNA transcript counts between timepoints.
Time frame
within 3 weeks of glofitamab therapy initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Joshua Brody
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: