Glofitamab in B-NHL Using Mid-Therapy Intratumoral Transcriptomics

Conditions

• Relapsed/Refractory Diffuse Large B-cell Lymphoma
• Relapsed/Refractory Mantle Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Glofitamab — BIOLOGICAL
  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.

Study Details

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.

Key Dates

First listed

Aug 5, 2026

Start date

Sep 30, 2026

Status verified

Jul 2026

Primary completion

Jul 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

16 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Participants with relapsed/refractory DLBCL or MCL
  Participants will receive step-up dosing of IV infusion of glofitamab on cycle 1 day 8 (2.5 mg) and cycle 1 day 15 (10 mg), followed by full dose (30 mg) starting on cycle 2 (C2) day 1 (day 22 overall) and then days 1±3 of all subsequent 21 day cycles.

Primary Outcome Measure

Proportion of patients with an increase of CD20(-) tumor cells >= 10 fold [ Time Frame: within 3 weeks of glofitamab therapy initiation ]

Central Contacts

• Martine Van Voorthuysen
  (646) 745-6092
  [email protected]

Locations (1)

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