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B-Cell Non-Hodgkin Lymphoma-RecurrentPhase 1NCT06209619

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

A Phase 1 study testing Biopsy, Biospecimen Collection and Computed Tomography in people with B-Cell Non-Hodgkin Lymphoma-Recurrent and Diffuse Large B-Cell Lymphoma-Recurrent, run by Nathan Denlinger at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy, Biospecimen Collection and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
29 Jan 2024to 31 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Pre-CART imaging within 90 days of infusion of CD19.CAR-T for baseline disease evaluation. If patient's receive bridging therapy, imaging evaluation post bridging therapy is encouraged as part of institutional guidelines, but not mandated for inclusion
Show all 34Show fewer
  • 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)
  • 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
  • Estimated glomerular filtration rate (eGFR) (based on chronic kidney disease-epidemiology collaboration [CKD-EPI] * patient's body surface area [BSA] [Du Bois method]/1.73m^2) ≥ 45 ml/min (obtained within 30 days prior to initiating study treatment)
  • 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
  • Bilirubin ≤ 1.5 × upper limit of normal (ULN). Subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level > 2.0 mg/dL if their conjugated bilirubin is < 2.0 × ULN) (obtained within 30 days prior to initiating study treatment)
  • 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
  • Aspartate aminotransferase (AST) ≤ 3.0 × ULN (obtained within 30 days prior to initiating study treatment)
  • 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
  • Alanine aminotransferase (ALT) ≤ 3.0 × ULN (obtained within 30 days prior to initiating study treatment)
  • 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
  • Patients must be able to provide adequate tissue samples for minimal residual disease (MRD) analysis for identification (ID) of baseline tumor deoxyribonucleic acid (DNA). 2 forms of tissue will be acceptable: optional baseline biopsy tissue post CART and prior to initiation of CC-99282, or archival tumor tissue (ex. formalin-fixed paraffin embedded [FFPE] tumor blocks) from a biopsy containing lymphoma prior to CD19.CART
  • Fridericia's formula-corrected QT interval (QTcF) < 470 ms
  • Patients must be able to swallow/absorb capsules
  • Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to enrollment. Pregnancy tests must be medically supervised with a minimum sensitivity of 25mIU/ml. NOTE: a female of childbearing potential is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months, i.e. has had menses at any time in the preceding 24 consecutive months. Documentation of postmenopausal status must be provided. Further information on pregnancy testing and the definition of a female of childbearing potential located in the CC-99282 pregnancy prevention plan document
  • Females of childbearing potential are required to use 2 forms of effective methods of contraception or to agree to practice complete abstinence from the time of informed consent, without interruption, at least 28 days before starting CC-99282, throughout the entire duration of CC-99282, during dose interruptions and for at least 6 months and 2 weeks after the last dose of golcadomide (BMS-986369)/CC-99282. The two contraception methods can be comprised one highly effective method and one additional effective (barrier) method. Further information on acceptable methods is located in the CC-99282 pregnancy prevention plan document
  • Male subjects with female partners must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of child bearing potential while taking CC-99282, during dose interruptions and for at least 3 months and 2 weeks following the last dose of CC-99282, even if he has undergone a successful vasectomy. Additional information regarding prevention of pregnancy as it pertains to male subjects is contained within the CC-99282 pregnancy prevention plan document
  • Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the experimental regimen are eligible for the trial
  • Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee

Who cannot join

  • 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
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site, 1 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Nathan Denlinger, DO, MS, 614-688-7940, nathan.denlinger@osumc.edu

    Nathan Denlinger, DO, MS

    Recruiting

Other trials in United States

About this study

Official title: Early, Risk Adapted CC-99282 + Rituximab Post CAR T-Cell Therapy for Non-Hodgkin's Lymphoma

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the safety profile and maximum tolerated dose (MTD) of early, risk adapted golcadomide (CC-99282)/rituximab for patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL) post-commercial CD19.CAR-T infusion.

SECONDARY OBJECTIVES:

  1. To perform a preliminary efficacy analysis of CC-99282 and rituxan early post CD19.CAR-T defined as the progression free survival (PFS) rate at day+150 post initiation of CC-99282.

II. To describe disease response rates in patients with active disease who are treated with CC-99282 + rituximab.

III. To estimate PFS in subjects treated with CC-99282 + rituximab. IV. To estimate the overall survival (OS) in subjects treated with CC-99282 + rituximab.

EXPLORATORY OBJECTIVES:

  1. To describe CD19.CAR-T cell expansion and persistence following treatment with CC-99282/rituximab.

II. To evaluate CC-99282/rituximab's effect on CAR T-cells and other immune cell subsets composition and how this effects clinical outcomes.

III. To evaluate CC-99282/rituximab's effect on CAR T-cell and other immune cell subset function and how this effects clinical outcomes.

IV. To evaluate CC-99282/rituximab's effect on the tumor microenvironment (TME) and how this effects clinical outcomes.

OUTLINE: This is a dose-escalation study of CC-99282 in combination with fixed-dose rituximab.

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.

After completion of study treatment, patients are followed up at days 240, 365, 455, 547, 637, and 730.

Being tested
Biopsy, Biospecimen Collection, Computed Tomography, Golcadomide, Positron Emission Tomography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT

  • GolcadomideDrug

    Also called BMS 986369, BMS-986369, BMS986369, CC -99282

    Given PO

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • RituximabBiological

    Also called ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody

    Given IV

Study groups in NCT06209619
Study groupRoleWhat they receive
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.
Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Golcadomide; Procedure: Positron Emission Tomography; Biological: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 30 days post completion of enrollment

  2. Maximum tolerated dose

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

    Measured: At 30 days post completion of enrollment

Secondary outcomes (7)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: At 60 days and 150 days post initiation of CC-99282

  5. Progression free survival

    Will be estimated using the Kaplan-Meier method.

    Measured: 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

  6. Overall survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Time from CD19.CAR-T infusion to date of death as a result of any cause, assessed at 150 days and 2 years post infusion of CD19.CAR-T cell therapy

  7. Incidence of adverse events

    The frequency and nature of adverse events associated with CC-99282 + rituximab post CD19.CAR-T cell therapy will be described using CTCAE v5.0.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2024
  2. Study start29 Jan 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06209619
Sponsor's protocol ID
OSU-23214
Other IDs
NCI-2023-10172
Status last verified
Feb 2026
First submitted
8 Jan 2024
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biopsy, Biospecimen Collection and Computed Tomography in people with B-Cell Non-Hodgkin Lymphoma-Recurrent and Diffuse Large B-Cell Lymphoma-Recurrent, run by Nathan Denlinger at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact The Ohio State Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: At 30 days post completion of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06209619.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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