PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL

Sponsor
University of Alabama at Birmingham
Study ID
NCT06290622
Phase
PHASE1
Status
Withdrawn

Conditions

  • Diffuse Large B Cell Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Follicular

Eligibility Criteria

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

Interventions

  • Retifanlimab, INCAGN02385, INCAGN02390 — DRUG
    Treatment: Retifanlimab -infused over 60 minutes for C1D1 followed by a 60-minute observation period. If no infusion related reactions are observed infusion may be reduced to 30 minutes and no further observation period is needed for future cycles. If there is a reaction continue with 60 minute infusion and observation period for following cycle. Retifanlimab should always be administered first. INCAGN02385 and INCAGN02390 -individually administered over 30 minutes one after another. For first infusions of retifanlimab, INCAGN02385 and INCAGN02390, a 4 hour observation period is necessary after completion of all infusion. If no infusion related reactions are observed, for subsequent infusions no further observation period is needed for future cycles.

Study Details

This study is investigating the optimal dose and the advantage in combining investigational immunotherapy drugs known as Retifanlimab, INCAGN02385 and INCAGN02390 to improve the responses to CAR T-cell therapy. Additionally, the study will investigate that triple checkpoint blockade of PD-1, TIM-3 and LAG-3 molecules will overcome CAR T-cell therapy resistance in patients with suboptimal responses.

Key Dates

Start date
Aug 30, 2024
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Jan 31, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level Assignments
    Dose Level 1 Retifanlimab 375mg INCAGN02385 250mg INCAGN02390 200mg Dose Level 2 Retifanlimab 500mg INCAGN02385 250mg INCAGN02390 200mg Dose Level 3 Retifanlimab 750mg INCAGN02385 250mg INCAGN02390 200mg

Primary Outcome Measure

Identify the optimal biological dose (OBD) for Retifanlimab in combination with INCAGN02385 and INCAGN02390 in relapsed/refractory DLBCL. [ Time Frame: 12 and 24 months ]

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