CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma

ConditionsB-Cell Non-Hodgkin Lymphoma-Recurrent Diffuse Large B-Cell Lymphoma-Recurrent Follicular Lymphoma-Recurrent High Grade B-Cell Lymphoma-Recurrent Primary Mediastinal Large B-Cell Lymphoma-Recurrent Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent B-Cell Non-Hodgkin Lymphoma-Refractory Diffuse Large B-Cell Lymphoma-Refractory Follicular Lymphoma-Refractory High Grade B-Cell Lymphoma-Refractory Primary Mediastinal Large B-Cell Lymphoma-Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Refractory

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorNathan Denlinger

About this trial

This phase I trial tests the safety, side effects and best dose of CC-99282 with rituximab for the treatment of patients who have received chimeric antigen receptor (CAR) T cell therapy for non-Hodgkins lymphoma and in whom have had a sub-optimal response early on to CAR T-cell therapy. Immunotherapy with CC-99282 may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving CC-99282 with rituximab may be a safe and effective treatment option for patients who have received CAR-T cell therapy for relapsed or refractory non-Hodgkin's lymphoma.

Eligibility criteria

Qualifiers

Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information

Age ≥ 18 years at the time of consent

Diagnosis of B-cell Non-Hodgkin's lymphoma including either large B-cell lymphoma or follicular lymphoma. Large B-cell subtypes include but are not limited to diffuse large B-cell lymphoma, high grade B-cell lymphoma (except Burkitt's Lymphoma), primary mediastinal B-cell lymphoma, and diffuse large B cell lymphoma transformed from indolent lymphomas

Eastern Cooperative Oncology Group (ECOG) Score = 0-2

Disqualifiers

Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study and lactating females must agree to not breastfeed while taking study drugs)

Uncontrolled concomitant illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, myocardial infarction within 1 month prior to enrollment, uncontrolled cardiac arrhythmias, uncontrolled seizures, or severe non compensated hypertension (Systolic blood pressure >= 180mmHg or diastolic blood pressure >= 120mmHg)

Receipt of CD19.CAR-T for any indication other than that stated within the inclusions criteria

CYP3A inhibitors: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin.

Trial design

Treatments tested in this trial

Biopsy
Biospecimen Collection
Computed Tomography
Golcadomide
Positron Emission Tomography
Rituximab

Treatment groups

18 Participants

are divided into 1 treatment group

Sponsors and collaborators

Nathan Denlinger

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov