Glofitamab in Relapsed or Refractory Diffuse Large B-cell Lymphoma After CD19 Chimeric Antigen Receptor T-cell Therapy

Sponsor
Samsung Medical Center
Study ID
NCT06552572
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glofitamab — DRUG
    Glofitamab is administered to patients who have residual disease after CD19 CAR T-cell therapy for their relapsed or refractory diffuse large B-cell lymphoma

Study Details

The objective of this clinical trial is to determine whether the CD20-CD3 bispecific antibody, glofitamab, is effective in treating residual diffuse large B-cell lymphoma (DLBCL) in adults who have responded to CD19 Chimeric antigen receptor (CAR) T-cell therapy for their relapsed or refractory DLBCL. Additionally, the trial will assess the safety of glofitamab in patients undergoing CD19 CAR T-cell therapy. The primary questions to be addressed are: Does glofitamab reduce the number of participants experiencing disease progression following CD19 CAR T-cell therapy? What are the medical complications in participants already treated with CD19 CAR T-cell therapy when administered glofitamab? Participants are required to: Receive glofitamab every 21 days for 12 cycles or until disease progression. Attend the clinic for checkups and tests every three weeks.

Key Dates

Start date
Nov 26, 2024
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Dec 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Glofitamab
    Glofitamab every 21 days for 12 cycles or until progression. 1. First cycle * Obinutuzumab (GPT) 1000mg (D1) * Glofitamab step up dosing 2.5mg (D8) → 10mg (D15) 2. After the first cycle (completed priming): 30mg IV every 3 weeks.

Primary Outcome Measure

1-year progression free survival rate after enrollment [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years ]

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