Actively Recruiting
Early, Risk Adapted CC-99282 with Rituximab After CAR T-Cell Therapy for Non-Hodgkin's Lymphoma
Led by Nathan Denlinger · Updated on 2026-02-27
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nathan Denlinger
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and best dose of a combination treatment using CC-99282 and rituximab in patients with relapsed or refractory non-Hodgkin lymphoma who have had a sub-optimal response early after receiving CD19-directed CAR T-cell therapy. This phase I trial aims to better understand how this combination affects the immune system and tumor growth. The study also explores how the treatment impacts CAR T-cell activity and the tumor environment. Participants receive rituximab through an intravenous infusion on the first day of each 28-day cycle and take CC-99282 orally once daily for the first 14 days of each cycle. Rituximab is given for up to 6 cycles, while CC-99282 can be continued for up to 26 cycles unless the disease progresses or unacceptable side effects occur. Patients may undergo biopsy at screening and have PET/CT scans and blood samples collected throughout the study. During the trial, patients are regularly monitored with imaging and laboratory tests to assess disease response and progression. Researchers measure treatment safety, maximum tolerated dose, progression-free survival, overall survival, and immune cell activity. After treatment, participants continue follow-up visits for up to two years to assess long-term outcomes and any lasting effects of the therapy.
CONDITIONS
Brief Title
CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization obtained
- Age 18 years or older at consent
- Diagnosis of B-cell Non-Hodgkin's lymphoma including large B-cell lymphoma or follicular lymphoma
- ECOG performance status of 0 to 2
- Prior standard of care CD19-directed CAR-T cell therapy received
- Pre-CAR-T imaging within 90 days of CD19.CAR-T infusion
- Evidence of objective response on PET/CT at 25-100 days post CD19.CAR-T compared to baseline
- Sub-optimal response to CD19.CAR-T defined by Deauville Score ≥ 3 on PET/CT at 25-100 days post infusion
- Absolute neutrophil count ≥ 7.5 x 10^8/L within 30 days prior to study treatment
- Partial response with persistent MRD positivity
- Hemoglobin ≥ 8 x 10^9/L within 30 days prior to study treatment
- Platelets ≥ 50 x 10^9/L within 30 days prior to study treatment
- Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min within 30 days prior to study treatment
- Bilirubin ≤ 1.5 times upper limit of normal (except Gilbert's syndrome exceptions)
- AST ≤ 3.0 times upper limit of normal within 30 days prior to study treatment
- ALT ≤ 3.0 times upper limit of normal within 30 days prior to study treatment
- Able to provide adequate tissue samples for MRD analysis
- Corrected QT interval (QTcF) < 470 ms
- Able to swallow and absorb capsules
- Females of childbearing potential must have negative pregnancy test and use contraception
- Male subjects with female partners must use contraception or abstain
- Prior or concurrent malignancy allowed if not interfering with study
- Willing and able to comply with study procedures
You will not qualify if you...
- Pregnant or breastfeeding
- Uncontrolled illnesses such as severe heart failure, unstable angina, recent heart attack, uncontrolled arrhythmias, seizures, or severe hypertension
- Receipt of CD19.CAR-T for indications not stated in inclusion criteria
- Use of strong CYP3A inhibitors or inducers unless washed out prior to study
- Receipt of other investigational agents within 2 weeks or 5 half-lives before enrollment
- Lactating females must agree not to breastfeed during study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 26 months (26 cycles of 28 days)
Participants receive rituximab intravenously on day 1 of each 28-day cycle and take CC-99282 orally once daily on days 1 through 14 of each cycle. Treatment may continue for up to 6 cycles of rituximab and up to 26 cycles of CC-99282 if there is no disease progression or unacceptable toxicity. Participants also undergo PET/CT scans and blood sample collections throughout this period to monitor their condition.
Up to 26 cycles with rituximab given on day 1 of each cycle and daily oral CC-99282 on days 1-14; PET/CT and blood samples collected periodically
Duration - Up to 2 years post treatment
After completing study treatment, participants are followed up to monitor their health and disease status at scheduled intervals.
6 visits at days 240, 365, 455, 547, 637, and 730 post treatment
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State Comprehensive Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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