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Withdrawn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

First listed
Jan 10, 2025
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 ]

Related Studies