Golcadomide and Nivolumab in Patients With Non-Hodgkin Lymphoma With Refractory Disease After Chimeric Antigen T-cell Therapy

Sponsor
University of Pittsburgh
Study ID
NCT06767956
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Non Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • GOLCADOMIDE — DRUG
    Golcadomide (GOLCA, CC-99282) is an oral cereblon E3 ligase modulator (CELMoD®) agent with immunomodulatory and tumor cell-autonomous activities. It is a modulator of the E3 ubiquitin ligase complex containing cereblon (CRL4-CRBN E3 ubiquitin ligase), with potential immunomodulating and antineoplastic activities.
  • Nivolumab — DRUG
    Nivolumab is an immune checkpoint inhibitor targeted therapy drug that blocks the PD-1 (programmed death receptor-1) pathway to help prevent cancer cells from hiding from the immune system, boosting the immune system's response.

Study Details

In this combined phase I/II, open label, single arm trial to study, the safety and efficacy of combination Golcadomide and nivolumab in patients with non-Hodgkin lymphoma (NHL) who have experienced refractory/residual disease, at or after 30 days of receiving chimeric antigen T-cell (CAR-T) therapy will be studied. A dose escalation phase will be followed by a dose expansion design.

Key Dates

Start date
Jun 30, 2025
Status verified
May 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

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

Arms

  • Experimental: GOLCADOMIDE + Nivolumab 480 mg IV
    GOLCADOMIDE PO QD (Day 1-14) Nivolumab 480 mg IV (Q4 wk) Continue up to 24 cycles or until intolerable toxicity or disease progression

Primary Outcome Measure

Maximum tolerated dose (MTD) / Recommended Phase 2 dose (RP2D) [ Time Frame: Up to 56 days from start of treatment ]

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