CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma
Early, Risk Adapted CC-99282 + Rituximab Post CAR T-Cell Therapy for Non-Hodgkin's Lymphoma
2 other identifiers
interventional
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2024
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2024
CompletedFirst Posted
Study publicly available on registry
January 17, 2024
CompletedStudy Start
First participant enrolled
January 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 27, 2026
February 1, 2026
2.9 years
January 8, 2024
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
At 30 days post completion of enrollment
Maximum tolerated dose
Will use Bayesian Optimal Interval design to define the maximum tolerated dose.
At 30 days post completion of enrollment
Secondary Outcomes (7)
Freedom from progression
At 150 days
Number of patients with response to treatment as assessed by PET imaging
At 60 days and 150 days post initiation of CC-99282 and then every 3 months, assessed up to 2 years
Number of patients with response to treatment as assessed by CT imaging
At 60 days and 150 days post initiation of CC-99282 and then every 3 months, assessed up to 2 years
Objective response rate
At 60 days and 150 days post initiation of CC-99282
Progression free survival
Time from initiation of CC-99282 to clinical progression or death, assessed at 150 days and 2 years post infusion of CD19.CAR-T cell therapy
- +2 more secondary outcomes
Study Arms (1)
Treatment (rituximab, CC-99282)
EXPERIMENTALPatients 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.
Interventions
Undergo blood sample collection
Undergo PET/CT
Given PO
Undergo PET/CT
Given IV
Eligibility Criteria
You may qualify if:
- 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
- Prior receipt of standard of care CD19 directed CAR-T cell therapy including axicabtagene ciloleucel, tisagenlecleucel, or lisocabtagene maraleucel
- Evidence of objective response on PET/CT at 25-100 days post CD19.CAR-T infusion compared to baseline pre-CART imaging. Objective response in this trial is defined by reduced fludeoxyglucose F-18 (FDG) uptake or reduction in mass size and includes mixed response
- Evidence of sub-optimal response to CD19.CAR-T as defined in this trial by Deauville Score ≥ 3 on PET/CT at 25-100 days post CD19.CAR-T infusion.
- Absolute neutrophil count ≥ 7.5 x 10\^8/L (obtained within 30 days prior to initiating study treatment)
- Evidence of partial response, though sub-optimal response as determined by persistent MRD positivity. (Example: Deauville Score 1 or 2 is eligible if MRD is positive via clonoseq).
- Hematological lab values should be without the use of growth factors or transfusion support
- Note: Changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
- Hemoglobin ≥ 8 x 10\^9/L (obtained within 30 days prior to initiating study treatment)
- Hematological lab values should be without the use of growth factors or transfusion support
- Note: Changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
- Platelets ≥ 50 x 10\^9/L (obtained within 30 days prior to initiating study treatment)
- +18 more criteria
You may not qualify if:
- 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)
- Concomitant use of strong CYP3A inhibitors and inducers. Examples include (but are not limited to):
- CYP3A inhibitors: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin.
- CYP3A inducers: carbamazepine, phenytoin, and rifampin. Patients that are able to come off moderate CYP3A inhibitors/inducers will require a washout period of at least 14 days or 5 half-lives, whichever is shorter, prior to the initiation of study treatment
- Patients who are actively receiving or have received other investigational agents, including herbal supplements, within 2 weeks or 5 half-lives of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nathan Denlingerlead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan Denlinger, DO, MS
Ohio State University Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 8, 2024
First Posted
January 17, 2024
Study Start
January 29, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02