[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"David Avigan\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100621700","phase-1-adoptive-t-cell-therapy-with-dcaml-fusion-vaccine-plus-decitabine-and-venetoclax-in-aml-100621700",false,"NCT07374029","Adoptive T Cell Therapy With DC\u002FAML Fusion Vaccine Plus Decitabine and Venetoclax in AML","A Phase 1, First in Human Study of Adoptive T Cell Therapy With T Cells Stimulated by Dendritic Cell (DC)\u002FTumor Fusions in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia (AML)","Inclusion Criteria Prior to Tumor Collection\n\n* Patients must have AML at initial diagnosis for which decitabine\u002Fvenetoclax is planned as standard of care therapy. This can include patients with IDH or FLT-3 mutations for whom the addition of targeted therapy agents directed at IDH or FLT-3 mutations to the decitabine\u002Fvenetoclax regimen is preferred per the treating physician.\n* Patients with AML in first relapse after cytotoxic and\u002For targeted therapy for which decitabine and venetoclax therapy is appropriate standard of care. This can include patients with IDH or FLT-3 mutations for whom the addition of targeted therapy agents directed at IDH or FLT-3 mutations to the decitabine\u002Fvenetoclax regimen is preferred per the treating physician.\n* ECOG performance status ≤ 2 (Appendix A)\n* Participants must have normal organ and marrow function as defined below:\n\n  * total bilirubin≤ 2.0 mg\u002FdL\n  * AST\u002FALT ≤ 3 × institutional upper limit of normal\n  * creatinine ≤ 2.0 mg\u002Fdl\n* The effects of vaccine stimulated T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria Prior to Tumor Collection\n\n* Patients diagnosed with acute promyelocytic leukemia\n* Patients treated at initial diagnosis who are appropriate for intensive induction therapy.\n* Patients with active systemic autoimmune disease requiring ongoing systemic therapy are excluded. The following is an exception to this criterion: subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement. Patients with paraneoplastic auto-immune manifestations related to AML are allowed.\n* Patients who have received a prior allogeneic transplant will be excluded.\n* Because of compromised cellular immunity, patients who have active human immunodeficiency virus (HIV), untreated hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).\n* Patients must not have active significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia.\n* Patients must not be pregnant. All premenopausal patients will undergo pregnancy testing. Men will agree to not father a child while on protocol treatment. Men and women will practice effective birth control while receiving protocol treatment.\n\nInclusion Criteria Prior to Leukapheresis\n\n* Patients must have obtained a response of PR or better to decitabine and venetoclax as defined in Section 11.\n* Resolution of all HMA\u002Fvenetoclax related grade III-IV toxicity as per CTC criteria 4.0, other than grade 3 anemia.\n* Laboratories:\n\n  * ANC ≥ 1,000\u002FµL\n  * Platelets ≥ 50,000\u002FuL\n  * Bilirubin ≤ 2.0 mg\u002FdL\n  * Creatinine ≤ 2.0 mg\u002FdL\n  * AST\u002FALT ≤ 3.0 x ULN\n\nExclusion Criteria Prior to Leukapheresis\n\n* Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure\n* Patients who, with their treating physician, choose to proceed with an allogeneic transplant at the time of remission will not be eligible for leukapheresis\n* Patients with active systemic autoimmune disease requiring ongoing systemic therapy are excluded. The following is an exception to this criterion: subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement. Patients with paraneoplastic auto-immune manifestations related to AML are permitted.\n* Current or prior use of immunosuppressive medication within 14 days prior to first T cell infusion. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (eg. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10mg\u002Fday of prednisone or equivalent\n* Known human immunodeficiency virus (HIV), untreated hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).\n* Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control from starting treatment, including dosing interruptions through 90 days after last dose of treatment. Refrain from egg cell donation while receiving vaccination and for at least 90 days after the last dose of treatment.\n* Male subjects who are not employing an effective method of birth control from starting vaccine, including dosing interruptions through 90 days after receipt of the last dose of treatment. Refrain from sperm cell donation while receiving vaccination and for at least 90 days after the last dose of treatment.\n\nInclusion Criteria Prior to Treatment with DC\u002FAML Primed T cells and DC\u002FAML fusion vaccine\n\n* Patient completed 4 cycles of decitabine and venetoclax without evidence of disease recurrence or progression\n* Resolution of all chemotherapy related grade III-IV toxicity as per CTC criteria 4.0, other than grade 3 anemia, at the time of initiation of cycle 5, 6, or 7 of decitabine\u002Fvenetoclax therapy.\n* Laboratories:\n\n  * ANC ≥ 1,000\u002FµL\n  * Platelets ≥ 50,000\u002FuL\n  * Bilirubin ≤ 2.0 mg\u002FdL\n  * Creatinine ≤ 2.0 mg\u002FdL\n  * AST\u002FALT ≤ 3.0 x ULN\n* Generation of adequate yield of T cells to meet dosing requirement","ALL",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","The goal of this research study is to test if the combination of a new T cell therapy (dendritic cell (DC) \u002F acute myeloid leukemia (AML) primed T cells), vaccine (DC\u002FAML fusion vaccine) and standard of care decitabine and venetoclax is feasible and safe and effective for treatment of acute myeloid leukemia (AML).\n\nThe names of the study drugs involved in this study are:\n\n* DC\u002FAML fusion vaccine (immune cell vaccine)\n* Granulocyte-macrophage colony-stimulating factor (GM-CSF) (a type of growth factor or hormone)\n* DC\u002FAML Primed T cells (immune cells)\n* Decitabine (a type of chemotherapy drug)\n* Venetoclax (a type of antineoplastic agent)",[25,26],"Acute Myeloid Leukemia","Acute Myeloid Leukemia, in Relapse",[28,29,30],"Acute Myeloid Leukemia (AML)","Newly Diagnosed Acute Myeloid Leukemia (AML)","Relapsed Acute Myeloid Leukemia (AML)","RECRUITING","2026-05-04",{"date":34,"type":35},"2026-05-05","ACTUAL",{"date":37,"type":35},"2026-02-12",{"date":39,"type":19},"2030-10-01",{"name":41,"class":42},"David Avigan","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":43},"100621962","phase-1-dcmm-fusion-vaccine-with-bcma-car-t-in-rr-mm-100621962","NCT07377435","DC\u002FMM Fusion Vaccine With BCMA CAR-T in R\u002FR MM","Phase I Study of Vaccination With DC\u002FMM Fusion Cells in Combination With BCMA Directed CAR-T Cell Therapy in Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Patients must be eligible to receive standard of care CAR T-cell therapy for relapsed or refractory multiple myeloma\n* Patients must be ≥18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Patients must have 20% or more plasma cells in the bone marrow core or aspirate differential within 30 days prior to enrollment.\n* Patients must have adequate organ function as defined below:\n\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal\n  * AST ≤ 3 x institutional upper limit of normal\n  * ALT ≤ 3 x institutional upper limit of normal\n  * Creatinine clearance ≥ 40 mL\u002Fmin for participants with creatinine levels above institutional normal\n* The effects of DC\u002FMM fusion vaccine on the developing human fetus are unknown. For this reason, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier methods of birth control or abstinence) prior to study enrollment and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of treatment.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients receiving other investigational drugs\n* Patients with Plasma Cell Leukemia\n\n  * Patients who have known active uncontrolled infections with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)\n  * Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.\n* Female patients who are pregnant (positive β-HCG) or breastfeeding.\n* Prior organ transplant requiring immunosuppressive therapy.\n* Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* History of intolerance to CAR-T related drugs or GM-CSF.\n\nInclusion Criteria Prior to Vaccination with DC\u002FMM Fusions:\n\n* Resolution of all CAR T- related grade 3-4 toxicities\n* Successful production of at least 2 vaccines with a minimum of 1 x 106 fusion cells\n* Absence of disease progression following CAR T-cell therapy\n* ECOG performance status ≤ 2\n* Patients must have adequate organ function as defined below:\n\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal\n  * AST ≤ 3 x institutional upper limit of normal\n  * ALT ≤ 3 x institutional upper limit of normal\n  * Creatinine within normal limits or Creatinine clearance ≥ 40 mL\u002Fmin for participants with creatinine levels above institutional normal\n  * ANC \\>1000 in the absence of growth factor support in the prior 7 days\n  * Platelet count \\>50K without the need for transfusion in the prior 7 days\n  * No myeloma-directed therapy following administration of CAR T-cells","18 Years",{"count":53,"type":19},25,[22],"This study is to evaluate the safety and effectiveness of dendritic cell DC\u002FMM fusion vaccine in combination with standard of care B-cell maturation antigen (BCMA) CAR-T cell therapy in participants with relapsed\u002Frefractory multiple myeloma.\n\nThe names of the study drugs involved in this study are:\n\n* DC\u002FMM fusion vaccine (a type of personalized cancer vaccine)\n* Granulocyte-macrophage colony-stimulating factor (GM-CSF) (a type of growth factor or hormone)",[57,58,59],"Multiple Myeloma","Refractory Multiple Myeloma","Relapse Multiple Myeloma",[57,58,61,62],"Relapsed Multiple Myeloma","MM",{"date":64,"type":35},"2026-05-08",{"date":66,"type":35},"2026-01-30",{"date":68,"type":19},"2032-03-01",{"name":41,"class":42},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":20,"phases":77,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100577494","phase-1-a-phase-1-study-of-vaccination-with-dendritic-cell-dcmultiple-myeloma-mm-fusions-in-combination-with-elranatamab-in-relapsed-or-refractory-multiple-myeloma-100577494","NCT06799026","A Phase 1 Study of Vaccination With Dendritic Cell (DC)\u002FMultiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma","Inclusion Criteria for Tumor Collection:\n\n* Participants must have an established diagnosis of multiple myeloma\n* Participant must have multiple myeloma and have relapsed following or are refractory to proteasome inhibitors, IMiDs and anti-CD38 mAb therapy\n* Participants must have at least 3 prior lines of therapy\n* Participants must be ≥18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Participants must have \\> 20% plasma cells in the bone marrow core or aspirate differential \\\u003C30 days prior to enrollment.\n* ANC \\> 1K\u002FuL; Platelets \\> 50 K\u002FuL without transfusional support\n* Participants must have adequate organ function as defined below:\n\n  * Total bilirubin ≤1.5 x institutional upper limit of normal\n  * AST ≤ 3 x institutional upper limit of normal\n  * ALT ≤ 3 x institutional upper limit of normal\n  * Creatinine clearance ≥ 40 mL\u002Fmin for participants with creatinine levels above institutional normal\n* The effects of DC\u002FMM fusion vaccine on the developing human fetus are unknown. For this reason, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier methods of birth control or abstinence) prior to study enrollment and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of treatment.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria for Tumor Collection:\n\n* Patients who are receiving any other investigational agents.\n* Patients with purely non-secretory MM \\[absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence- Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain \\>100 mg\u002FL\\]. Patients with light chain MM detected in the serum by free light chain assay are eligible.\n* Patients with Plasma Cell Leukemia\n* Because of compromised cellular immunity, patients who have a known human immunodeficiency virus (HIV), active hepatitis C virus (HCV) or active hepatitis B virus (HBV).\n* Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure (see Appendix H), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.\n* Active and clinically significant autoimmune or inflammatory disorder requiring active treatment\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances. Note: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non- invasive cancer (such as, any in situ cancers) and basal cell or squamous cell carcinoma of the skin.\n* Female patients who are pregnant (positive β-HCG) or breastfeeding\n* Prior organ transplant requiring immunosuppressive therapy.\n* Patients who previously received PD-1 antibody and have experienced toxicities resulting in treatment discontinuation.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.\n\nEligibility Criteria Prior to Vaccination with DC\u002FMM fusions\n\n* Resolution of all elranatamab related ≥ grade 3 or higher toxicities to grade 1 or baseline. Isolated laboratory abnormalities that are not considered to be clinically significant are not exclusionary.\n* Successful production of at least 2 vaccines with a minimum of 1 x 106 fusion cells per vaccine\n* Absence of disease progression following 2 cycles of elranatamab therapy\n* ECOG performance status ≤ 2\n\nParticipants must have adequate organ function as defined below:\n\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal\n* AST ≤ 3 x institutional upper limit of normal\n* ALT ≤ 3 x institutional upper limit of normal\n* ANC \\> 1K\u002FuL; Platelets \\> 50 K\u002FuL without transfusional support\n* Creatinine clearance ≥ 40 mL\u002Fmin for participants with creatinine levels above institutional normal",{"count":53,"type":19},[22],"This research is being done to determine if the combination of the Dendritic Cell (DC)\u002F Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating Relapsed or Refractory Multiple Myeloma (MM).\n\nThe names of the study drugs and vaccine involved in this study are:\n\n* DC\u002FMM fusion vaccine (a personalized cancer vaccine in which harvested participant tumor cells are fused with harvested participant dendritic blood cells)\n* Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (a type of growth factor)\n* Elranatamab (a type of T-cell engager antibody)",[57,59,58],[62,57,59,58],{"date":82,"type":35},"2026-05-07",{"date":84,"type":35},"2025-01-31",{"date":86,"type":19},"2030-09-01",{"name":41,"class":42},2,""]