BridgeMD
New treatment option for B-Cell Non-Hodgkin Lymphoma-Recurrent
Official title CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma
ClinicalTrials.gov ID: NCT06209619
What this study is testing
What is Golcadomide?
Golcadomide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for b-cell non-hodgkin lymphoma-recurrent.
Also referred to as BMS 986369, BMS-986369.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for...
- 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...
- 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
You likely can't join 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...
- Uncontrolled concomitant illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or...
- 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...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Bilirubin ≤ 1.5 × upper limit of normal (ULN). people 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Male people 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...
- people with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the experimental regimen are eligible for the...
- Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
What rules you out
- 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...
- 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...
- Patients who are actively receiving or have received other investigational agents, including herbal supplements, within 2 weeks or 5 half-lives of enrollment
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.