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

ConditionsB-Cell Non-Hodgkin Lymphoma-RecurrentDiffuse Large B-Cell Lymphoma-RecurrentFollicular Lymphoma-RecurrentHigh Grade B-Cell Lymphoma-RecurrentPrimary Mediastinal Large B-Cell Lymphoma-RecurrentTransformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-RecurrentB-Cell Non-Hodgkin Lymphoma-RefractoryDiffuse Large B-Cell Lymphoma-RefractoryFollicular Lymphoma-RefractoryHigh Grade B-Cell Lymphoma-RefractoryPrimary Mediastinal Large B-Cell Lymphoma-RefractoryTransformed 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Undergo biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Golcadomide

    Drug

    Given PO

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Rituximab

    Biological/Vaccine

    Given IV

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Treatment (rituximab, CC-99282)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Will describe frequency and nature of adverse events associated with CC-99282 + rituximab post CD19 chimeric antigen receptor (CAR) -T cell therapy using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

Time frame
At 30 days post completion of enrollment
2

Maximum tolerated dose

Will use Bayesian Optimal Interval design to define the maximum tolerated dose.

Time frame
At 30 days post completion of enrollment

Secondary outcomes

1

Freedom from progression

Will utilize baseline positron emission tomography/computed tomography at 30 days post infusion of CD19.CART compared to day+150 PET post initiation of CC-99282.

Time frame
At 150 days
2

Number of patients with response to treatment as assessed by PET imaging

Patients with response to treatment assessed by PET imaging and as defined by the Lugano criteria. Lugano classification is a five-point scale for reporting FDG PET.

Time frame
At 60 days and 150 days post initiation of CC-99282 and then every 3 months, assessed up to 2 years
3

Number of patients with response to treatment as assessed by CT imaging

Patients with response to treatment assessed by CT imaging and as defined by the Lugano criteria. Lugano classification is a five-point scale for reporting FDG PET.

Time frame
At 60 days and 150 days post initiation of CC-99282 and then every 3 months, assessed up to 2 years
4

Objective response rate

Will be calculated with 95% confidence interval.

Time frame
At 60 days and 150 days post initiation of CC-99282

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nathan Denlinger

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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