A Study of Polatuzumab Vedotin and Glofitamab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Within 12 Months After R-CHOP

Sponsor
Yonsei University
Study ID
NCT07702851
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Polatuzumab vedotin, Glofitamab — DRUG
    Participants will receive fixed-duration treatment with polatuzumab vedotin in combination with glofitamab. Obinutuzumab 1000 mg will be administered once by intravenous infusion on Cycle 1 Day 1 as pretreatment before glofitamab administration. Polatuzumab vedotin 1.8 mg/kg will be administered by intravenous infusion on Cycle 1 Day 2 and then on Day 1 of each cycle from Cycle 2 through Cycle 6. Glofitamab will be administered by intravenous infusion using step-up dosing: 2.5 mg on Cycle 1 Day 8, 10 mg on Cycle 1 Day 15, and 30 mg on Day 1 of each cycle from Cycle 2 through Cycle 12. Each cycle is 21 days.

Study Details

Patients with diffuse large B-cell lymphoma (DLBCL) who are primary refractory to first-line R-CHOP therapy or relapse within 12 months after R-CHOP have a poor prognosis and limited treatment options. Conventional salvage chemotherapy has limited efficacy, and CAR-T cell therapy may be limited by manufacturing time, accessibility, and patient condition. Therefore, an immediately available, chemotherapy-free treatment strategy that may reduce the cumulative toxicity of conventional cytotoxic chemotherapy is needed. Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that delivers a cytotoxic agent to malignant B cells, and glofitamab is a CD20×CD3 bispecific antibody that activates T cells and induces immune-mediated antitumor activity. The combination of these two agents may provide complementary antitumor effects through direct tumor cell killing and T-cell-mediated immune response. This single-arm, open-label, phase 2 study will evaluate the efficacy and safety of polatuzumab vedotin in combination with glofitamab in patients with DLBCL who are primary refractory to or relapse within 12 months after first-line R-CHOP therapy. Approximately 47 participants will be enrolled. The primary endpoint is the complete response rate at the end of treatment, as assessed by the investigator according to Lugano 2014 criteria.

Key Dates

First listed
Jul 14, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

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

Arms

  • Experimental: Polatuzumab vedotin, Glofitamab
    Participants will receive fixed-duration treatment with polatuzumab vedotin in combination with glofitamab, followed by glofitamab monotherapy. Treatment will be administered in 21-day cycles for up to 12 cycles. In Part A, corresponding to Cycles 1 through 6, participants will receive obinutuzumab pretreatment, polatuzumab vedotin, and glofitamab. In Part B, corresponding to Cycles 7 through 12, participants will receive glofitamab monotherapy.

Primary Outcome Measure

Complete response rate at the end of treatment [ Time Frame: At the end of treatment (EOT), up to approximately 36 weeks after the first dose. ]

Central Contacts

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