A Phase II Study of Stapokibart Combined With Immune Checkpoint Inhibitors in Relapsed/Refractory Lymphoma

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT07791615
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Stapokibart, immune checkpoint inhibitor — DRUG
    Stapokibart, subcutaneous injection (SC), every 3 weeks (Q3W); Immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Sintilimab), Q3W; until disease progression.

Study Details

This is an open-label clinical study designed to evaluate the efficacy of Stapokibart combined with immune checkpoint inhibitors in patients with relapsed/refractory lymphoma. Approximately 20 patients with relapsed/refractory lymphoma who have failed prior immune checkpoint inhibitor therapy or failed to achieve remission are planned to be enrolled.

Key Dates

First listed
Aug 28, 2026
Start date
Dec 31, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

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

Arms

  • Experimental: Stapokibart combination investigational arm
    Participants will receive combination therapy with stapokibart and an immune checkpoint inhibitor.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: 6 months ]

Central Contacts

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