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 — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Golcadomide — DRUG
    Given PO
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Rituximab — BIOLOGICAL
    Given 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

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Nathan Denlinger, DO, MS
614-688-7940
Nathan Denlinger, DO, MS (PRINCIPAL_INVESTIGATOR)

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