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Monoclonal Antibodies

CC-99282 + Rituximab for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Led By Nathan Denlinger, DO, MS

Research Sponsored by Nathan Denlinger

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Evidence of sub-optimal response to CD19.CAR-T as defined in this trial by Deauville Score ≥ 3 on PET/CT at 30 days post CART infusion (+15/-5 days)

Must not have

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

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of a combination of CC-99282 and rituximab for the treatment of patients with non-Hodgkin's lymphoma who have not responded well

Who is the study for?

This trial is for patients with various types of Non-Hodgkin's Lymphoma who have had a less than ideal response to CAR T-cell therapy. It's important that participants haven't responded well to this prior treatment and are now looking for additional options.

What is being tested?

The trial is testing the combination of a new immunotherapy drug, CC-99282, with an established cancer drug called Rituximab. The study aims to find the safest dose and observe how these drugs affect the immune system in attacking lymphoma cells post CAR-T therapy.

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as fever or fatigue, issues where CC-99282 is injected, and possible complications from Rituximab like infections or heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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My cancer did not respond well to a specific immune therapy, as shown by a special scan.

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My kidney function, measured by eGFR, is sufficient for the study.

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I agree to follow strict birth control or abstinence guidelines while on CC-99282 treatment.

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I have been diagnosed with a type of B-cell Non-Hodgkin's lymphoma.

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I can swallow and absorb pills.

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I have previously received a specific CAR-T cell therapy for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received CD19.CAR-T therapy for conditions outside those specified.

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I do not have severe heart problems, uncontrolled seizures, or very high blood pressure.

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I am not using strong medication that affects liver enzymes.

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I haven't taken any experimental drugs or herbal supplements in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose

Secondary study objectives

Freedom from progression

Incidence of adverse events

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

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (rituximab, CC-99282)Experimental Treatment6 Interventions

Patients receive rituximab IV on day 1 of each cycle and CC-99282 PO QD on days 1-14 of each cycle. Treatment repeats every 28 days for up to 6 cycles of rituximab and up to 24 cycles of CC-99282 in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT and collection of blood samples throughout the trial. Patients may undergo biopsy at screening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Biopsy

2014

Completed Phase 4

~1150