[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nathan Denlinger\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644923","phase-1-lymphodepletion-with-low-dose-total-body-irradiation-before-standard-of-care-tisagenlecleucel-for-the-treatment-of-relapsed-and-recurrent-large-b-cell-lymphoma-100644923",false,"NCT07676877","Lymphodepletion With Low Dose Total Body Irradiation Before Standard of Care Tisagenlecleucel for the Treatment of Relapsed and Recurrent Large B-cell Lymphoma","A Phase I Trial of Lymphodepletion Intensification With Low Dose Total Body Irradiation With Dose Expansion for Standard-of-Care Tisagenlecleucel in Patients With Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Eligible for standard of care anti-CD19 CAR-T treatment with Tisa-cel\n* Age ≥ 18 years\n* Biopsy-confirmed relapsed or refractory large B-cell lymphoma after 2 lines of prior therapy\n* Qualitative CD19 expression by either immunohistochemistry (IHC) or flow cytometry\n* Measurable disease prior to lymphodepletion as determined by Lugano criteria\n* Non-RT bridging therapy allowed, but requires re-staging prior to lymphodepletion (LD) to confirm measurable disease\n* Adequate performance status Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Platelets above 75K\n* Hemoglobin above 8.0 g\u002FdL without transfusion within 1 week\n* Absolute neutrophil count (ANC) above 1,000 without granulocyte colony-stimulating factor (G-CSF) within 1 week\n* Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) =\\\u003C 3 x ULN\n* Glomerular filtration rate (GFR) \\> 60 ml\u002Fmin calculated by the Cockcroft - Gault formula\n* Oxygen saturation (SpO2) \\> 92% without supplemental oxygen\n* Ejection fraction more than 45%\n* Patients must have the ability to understand and the willingness to sign a written informed consent document\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 12 months after Tisa-cel and until CAR T-cells are no longer present by quantitative polymerase chain reaction (qPCR) on two consecutive tests\n* A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptive s that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n\n  * With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 12 months after Tisa-cel infusion and until CAR T-cells are no longer present by qPCR on two consecutive tests. Men must refrain from donating sperm during this same period\n  * With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after Tisa-cel infusion to avoid potential embryonal or fetal exposure. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception\n* For patients with prior irradiation: the study radiation oncologist co-investigator will review the patient's prior history of radiation to confirm that the investigational low dose total body irradiation is feasible and safe to respect the maximum cumulative organ radiation exposure\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease at screening or prior to lymphodepletion\n* Prior therapy with autologous or allogenic CAR-T or CAR-natural killer (NK) cell therapy\n* Prior anti-CD19 therapies (such as, but not limited to tafasitamab or loncastuximab)\n* Prior allogeneic stem cell transplant\n* Bridging therapy with radiation not allowed\n* Any contra-indications to receive low-dose TBI, standard of care lymphodepleting chemotherapy or Tisa-cel per treating physician\n* A minimum of 28 days must have elapsed between prior treatment with investigational agent(s) and start of lymphodepletion\n* Uncontrolled major medical problem as infections\n* Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast). Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial (e.g. low Gleason score prostate cancer)\n* Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study\n* Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy\n* Active hepatitis B or C as indicated by serology (for details please refer to Novartis Leukapheresis Reference Manual version \\[v\\] 4)\n* Patients with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease\n* History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) with requirement of systemic immunosuppressive medication within 6 months\n* Live vaccines given in 28 days prior to lymphodepleting chemotherapy\n* Active substance use disorders","ALL","18 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial tests the safety, side effects, and best dose of total body irradiation (TBI) in combination with standard of care lymphodepletion with cyclophosphamide and fludarabine before tisagenlecleucel (Tisa-cel) and how well the combination works in patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). TBI is a common treatment that sends radiation (for example, through x-rays) to the entire body. Lymphodepleting chemotherapy, such as cyclophosphamide and fludarabine, along with TBI helps kill cancer cells in the body and helps prepare the body for the Tisa-cel infusion. Tisagenlecleucel is made using a patient's T cells (a type of immune system cell). A gene for a special receptor called chimeric antigen receptor (CAR) is added to the T cells in the laboratory. These changed T cells called CAR T cells are grown in large numbers in the laboratory and given to the patient by infusion. Tisa-cel binds to a protein called CD19, which is found on some leukemia and lymphoma cells. This helps the body's immune system kill cancer cells. Tisa-cel is a type of CAR T-cell therapy. Giving low dose TBI in combination with standard of care lymphodepletion therapy and Tisa-cel may be safe, tolerable, and\u002For effective in treating patients with relapsed or refractory (R\u002FR) LBCL.",[26,27],"Recurrent Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","NOT_YET_RECRUITING","2026-06-23",{"date":31,"type":32},"2026-06-30","ACTUAL",{"date":34,"type":20},"2026-09-01",{"date":36,"type":20},"2027-12-31",{"name":38,"class":39},"Nathan Denlinger","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":40},"100532193","phase-1-cc-99282--rituximab-early-post-cart-for-non-hodgkins-lymphoma-100532193","NCT06209619","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","Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\n* Age ≥ 18 years at the time of consent\n* 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\n* Eastern Cooperative Oncology Group (ECOG) Score = 0-2\n* Prior receipt of standard of care CD19 directed CAR-T cell therapy including axicabtagene ciloleucel, tisagenlecleucel, or lisocabtagene maraleucel\n* 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\n* Evidence of objective response on PET\u002FCT 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\n* Evidence of sub-optimal response to CD19.CAR-T as defined in this trial by Deauville Score ≥ 3 on PET\u002FCT at 25-100 days post CD19.CAR-T infusion.\n* Absolute neutrophil count ≥ 7.5 x 10\\^8\u002FL (obtained within 30 days prior to initiating study treatment)\n* 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).\n\n  * Hematological lab values should be without the use of growth factors or transfusion support\n  * 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\u002For worsen from baseline during therapy\n* Hemoglobin ≥ 8 x 10\\^9\u002FL (obtained within 30 days prior to initiating study treatment)\n\n  * Hematological lab values should be without the use of growth factors or transfusion support\n  * 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\u002For worsen from baseline during therapy\n* Platelets ≥ 50 x 10\\^9\u002FL (obtained within 30 days prior to initiating study treatment)\n\n  * Hematological lab values should be without the use of growth factors or transfusion support\n  * 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\u002For worsen from baseline during therapy\n* Estimated glomerular filtration rate (eGFR) (based on chronic kidney disease-epidemiology collaboration \\[CKD-EPI\\] \\* patient's body surface area \\[BSA\\] \\[Du Bois method\\]\u002F1.73m\\^2) ≥ 45 ml\u002Fmin (obtained within 30 days prior to initiating study treatment)\n\n  * 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\u002For worsen from baseline during therapy\n* Bilirubin ≤ 1.5 × upper limit of normal (ULN). Subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level \\> 2.0 mg\u002FdL if their conjugated bilirubin is \\\u003C 2.0 × ULN) (obtained within 30 days prior to initiating study treatment)\n\n  * 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\u002For worsen from baseline during therapy\n* Aspartate aminotransferase (AST) ≤ 3.0 × ULN (obtained within 30 days prior to initiating study treatment)\n\n  * 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\u002For worsen from baseline during therapy\n* Alanine aminotransferase (ALT) ≤ 3.0 × ULN (obtained within 30 days prior to initiating study treatment)\n\n  * 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\u002For worsen from baseline during therapy\n* 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\n* Fridericia's formula-corrected QT interval (QTcF) \\\u003C 470 ms\n* Patients must be able to swallow\u002Fabsorb capsules\n* 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\u002Fml. 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\n* 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)\u002FCC-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\n* 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\n* 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\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee\n\nExclusion Criteria:\n\n* 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)\n* 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)\n* Receipt of CD19.CAR-T for any indication other than that stated within the inclusions criteria\n* Concomitant use of strong CYP3A inhibitors and inducers. Examples include (but are not limited to):\n\n  * CYP3A inhibitors: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin.\n  * CYP3A inducers: carbamazepine, phenytoin, and rifampin. Patients that are able to come off moderate CYP3A inhibitors\u002Finducers will require a washout period of at least 14 days or 5 half-lives, whichever is shorter, prior to the initiation of study treatment\n* Patients who are actively receiving or have received other investigational agents, including herbal supplements, within 2 weeks or 5 half-lives of enrollment",{"count":19,"type":20},[23],"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.",[52,53,54,55,56,57,58,59,60,61,62,63],"B-Cell Non-Hodgkin Lymphoma-Recurrent","Diffuse Large B-Cell Lymphoma-Recurrent","Follicular Lymphoma-Recurrent","High Grade B-Cell Lymphoma-Recurrent","Primary Mediastinal Large B-Cell Lymphoma-Recurrent","Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent","B-Cell Non-Hodgkin Lymphoma-Refractory","Diffuse Large B-Cell Lymphoma-Refractory","Follicular Lymphoma-Refractory","High Grade B-Cell Lymphoma-Refractory","Primary Mediastinal Large B-Cell Lymphoma-Refractory","Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Refractory","RECRUITING","2026-02-24",{"date":67,"type":32},"2026-02-27",{"date":69,"type":32},"2024-01-29",{"date":71,"type":20},"2026-12-31",{"name":38,"class":39},""]