New drug cocktail aims to boost CAR T-Cell success in lymphoma
NCT ID NCT06209619
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing whether adding two drugs—CC-99282 and rituximab—can help people with non-Hodgkin lymphoma who didn't get a good result from CAR T-cell therapy. The study will enroll 18 adults with relapsed or refractory B-cell lymphoma. Researchers are looking for the safest dose and checking for side effects, while also seeing if the combo can stop the cancer from growing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Golcadomide (CC-99282) plus rituximab
- What this could lead to
- If this works, it could offer a new treatment option for lymphoma patients who don't respond well to CAR T-cell therapy, potentially improving their chances of staying cancer-free.
- What could go wrong
- This is a very early phase 1 trial with only 18 participants, so the safety and effectiveness are not yet proven. The drug combo may cause side effects or fail to improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2024
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for B-cell non-Hodgkin lymphoma-recurrent are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43210, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a drug duo outsmart returning lymphoma?
- New combo therapy aims to stop aggressive lymphoma relapse
- New combo aims to boost CAR-T safety in lymphoma patients
- New hope for lymphoma patients after CAR T-Cell failure
- New combo aims to boost CAR T-Cell therapy for rare lymphoma
- New antibody drug may boost transplant success in tough lymphoma