Golcadomide + Nivolumab for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByNatalie Galanina, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Natalie Galanina

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with Non-Hodgkin Lymphoma who haven't responded to CAR-T therapy. Participants should be at least 30 days post-CAR-T treatment and meet other health requirements set by the study.

Inclusion Criteria

I am 18 years old or older.

I have received an FDA-approved CAR T-cell therapy targeting CD19.

I can take care of myself and am up and about more than half of the day.

I am HIV positive, on treatment, and my viral load is undetectable.

I have a type of aggressive large B-cell lymphoma.

My cancer shows up on PET scans and can be measured.

My cancer has spread to my brain from another part of my body.

Exclusion Criteria

I have not had cancer treatment after my CAR-T therapy.

I am not taking strong medication that affects liver enzyme activity.

Participant Groups

The trial tests Golcadomide combined with Nivolumab in a two-phase approach: first, finding the right dose (escalation), then giving it to more people (expansion) to see how safe and effective it is.

1Treatment groups

Experimental Treatment

Group I: GOLCADOMIDE + Nivolumab 480 mg IVExperimental Treatment2 Interventions

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