Golcadomide and Nivolumab in Patients With Non-Hodgkin Lymphoma With Refractory Disease After Chi… (NCT06767956) | Clinical Trial Compass
WithdrawnPhase 1/2
Golcadomide and Nivolumab in Patients With Non-Hodgkin Lymphoma With Refractory Disease After Chimeric Antigen T-cell Therapy
Stopped: IND Sponsor-Investigator left institution
0Started 2025-06-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provision of signed informed consent and willingness to comply with all study requirements for the duration of the study.
✓. Patients 18 years of age or older.
✓. Patients must have histologically confirmed high-grade large B-cell lymphoma such as diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL grade 3B), primary mediastinal B-cell lymphoma (PMBCL). Patient with transformation from indolent to large cell lymphoma will be allowed to enroll in the study.
✓. Presence of FDG avid, radiographically measurable disease (Deauville 4-5) per Lugano 2014 response criteria which will include patients with metabolic partial response (PR), stable disease (SD), and progressive disease (PD), as assessed by the investigator.
✓. Patients who received FDA-approved CD19-directed CAR T-cell product(s) (exclusive of any investigational CAR T-cell products).
✓. Evidence of measurable residual disease 30 days and up to 1 year after receiving CAR-T therapy. Screening visit should be performed no later than day 365 after CAR-T infusion.
✓. Eastern Cooperative Oncology group ECOG performance status ≤ 2.
✓. Patients must have adequate organ and marrow function as defined in the protocol at the time of consent. Abnormalities reasonably attributed to underlying lymphoma will be allowed (e.g. anemia due to marrow involvement or LFT elevation due to metastatic involvement)
Exclusion criteria
✕. Treatment with any intervening anti-cancer therapies (other than palliative radiation) following CAR-T therapy. This study is intended to be the first treatment of residual disease after CAR-T therapy.
What they're measuring
1
Maximum tolerated dose (MTD) / Recommended Phase 2 dose (RP2D)
✕. Patients who have not recovered from AEs (other than hematologic) of prior anti-neoplastic therapy (i.e., have residual toxicities \> Grade 1) for the exception of alopecia, that require active management.
✕. Hypersensitivity reaction to any of the study drugs or their derivatives.
✕. Medical or psychiatric co-morbidities that in the opinion of the treating physician may compromise either compliance with or tolerance of study drugs.
✕. Patients with GI malabsorption that may compromise absorption of oral golcadomide.
✕. Presence of active autoimmune disease.
✕. Patients requiring strong CYP3A inducers or inhibitors will be excluded. Note:
✕. Avoid coadministration of moderate CYP3A inhibitors and