Phase II Trial of Glofitamab in B-NHL Using Mid-Therapy Intratumoral Transcriptomics
Joshua Brody
Summary
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.
Description
This trial will enable patients with relapsed/refractory disease to receive glofitamab at an earlier line than is currently approved in the United States. Overall, it is anticipated that the benefits of glofitamab as a single agent will outweigh its potential risks, particularly given the poor prognosis of patients with relapsed/refractory DLBCL or MCL who have failed SoC regimens. Glofitamab offers high rates of complete response with durable disease control and favorable toxicity profile relative to current SoC regimens, such as chemotherapy or autologous stem cell transplantation.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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, * inguinal, subcutaneous. * Disease that has progressed (clinically or radiographically) after standard-of-care * prior therapy, including anthracycline-based therapy for DLBCL and anti-CD20 * mAb-based therapy for all histologies. Exclusion Criteria: Patients who meet any of the following criteria will be excluded from study entry:…
Interventions
- BiologicalGlofitamab
Glofitamab 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.
Location
- Icahn School of Medicine at Mount SinaiNew York, New York