CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Nathan Denlinger
- Study ID
- NCT06209619
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- B-Cell Non-Hodgkin Lymphoma-Recurrent
- B-Cell Non-Hodgkin Lymphoma-Refractory
- Diffuse Large B-Cell Lymphoma-Recurrent
- Diffuse Large B-Cell Lymphoma-Refractory
- Follicular Lymphoma-Recurrent
- Follicular Lymphoma-Refractory
- High Grade B-Cell Lymphoma-Recurrent
- High Grade B-Cell Lymphoma-Refractory
- Primary Mediastinal Large B-Cell Lymphoma-Recurrent
- Primary Mediastinal Large B-Cell Lymphoma-Refractory
- Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent
- Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Refractory
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biopsy — PROCEDUREUndergo biopsy
- Biospecimen Collection — PROCEDUREUndergo blood sample collection
- Computed Tomography — PROCEDUREUndergo PET/CT
- Golcadomide — DRUGGiven PO
- Positron Emission Tomography — PROCEDUREUndergo PET/CT
- Rituximab — BIOLOGICALGiven IV
Study Details
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.
Key Dates
- Start date
- Jan 29, 2024
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 18 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (rituximab, CC-99282)Patients receive rituximab intravenously (IV) on day 1 of each cycle and CC-99282 orally (PO) once daily (QD) on days 1-14 of each cycle. Treatment repeats every 28 days for up to 6 cycles of rituximab and up to 26 cycles of CC-99282 in the absence of disease progression or unacceptable toxicity. Patients also undergo positron emission tomography (PET)/computed tomography (CT) and collection of blood samples throughout the trial. Patients may undergo biopsy at screening.
Primary Outcome Measure
Incidence of adverse events [ Time Frame: At 30 days post completion of enrollment ]
Central Contacts
- The Ohio State Comprehensive Cancer Center800-293-5066
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Nathan Denlinger, DO, MS (PRINCIPAL_INVESTIGATOR) |