[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-precursor-all\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-precursor-all":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":39,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":5},"100473255","phase-1-cd19cd22-bicistronic-chimeric-antigen-receptor-car-t-cells-in-children-and-young-adults-with-recurrent-or-refractory-b-cell-malignancies-100473255",false,"NCT05442515","CD19\u002FCD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","Phase 1\u002F2 Dose Escalation Study of CD19\u002FCD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","* INCLUSION CRITERIA:\n* Diagnosis\n\n  * Participant must:\n\n    * Have pathology confirmed B cell ALL (not isolated to the testis or CNS), CML with ALL transformation, or high-grade lymphoma (e.g., Burkitt's lymphoma, B-lymphoblastic lymphoma, diffuse large B-cell lymphoma, inclusive of low-grade lymphoma that has transformed to high grade disease); and\n    * Have relapsed or been refractory after at least one standard chemotherapy regimen and at least one salvage treatment. Participants with Philadelphia chromosome + ALL must have failed prior tyrosine kinase inhibitor; and\n    * Be ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have recurred after SCT; and\n    * Be unable to access (in a timely manner), ineligible for, or have relapsed\u002Ffailed after or not responded to a commercially available CD19 CAR T-cell construct; and\n  * Have evidence of at least minimal residual disease or PET-avid disease (lymphoma) at the time of enrollment.\n* CD22\u002FCD19 expression\n\n  * Cohorts A1b, B1b, C2b\n\n    * CD19 must be detected on \\>15% of the malignant cells by immunohistochemistry or \\> 80% by flow cytometry.\n    * CD22 positivity must be confirmed.\n  * Cohorts D1b, 2 B-ALL\n\n    * CD19 or CD22 positivity must be confirmed\n    * Age \\>= 3 years of age and \\\u003C=39 years of age at time of enrollment.\n    * Clinical Performance status: Participants \\>= 16 years of age: Karnofsky \\>= 50%; Participants \\\u003C 16 years of age: Lansky scale \\>= 50%.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>= 750\u002FmcL\\*\n  * platelets \\>= 50,000\u002FmcL\\*\n  * total bilirubin \\\u003C=2 X ULN (except in the case of participants with documented Gilbert's disease \\> 3x ULN)\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C=10 X institutional upper limit of normal\n  * creatinine \\\u003C= the maximum for age listed in the table below OR\n  * measured creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above the max listed below per age.\n\n    * Age (Years) \\\u003C= 5 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 0.8\n    * Age (Years) 6 to \\\u003C= 10 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 1.0\n    * Age (Years) \\>10 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 1.2\n\n      * a participant will not be excluded because of pancytopenia \\>= Grade 3 if it is due to underlying bone marrow involvement by leukemia\n* Central nervous system (CNS) Status\n* Participants with leukemia with CNS 1 and 2 disease are eligible in the absence of exclusion criteria\n* Participants of child-bearing or child-fathering potential must be willing to practice effective birth control from the time of enrollment until 12 months following completion of study treatment for women and for 4 months following completion of study treatment for men.\n* Participants who are breastfeeding or plan to breastfeed must agree to discontinue\u002Fpostpone breastfeeding while on study therapy and until 1 month after the administration of CAR.\n* Cardiac function: Left ventricular ejection fraction \\>= 45% or fractional shortening \\>=28%\n* Pulmonary Function\n\n  * Baseline oxygen saturation \\>92% on room air at rest\n* Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n* Ability and willingness of participant or Legally Authorized Representative (LAR) to co- enroll on 15-C-0028: Follow-up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.\n\nEXCLUSION CRITERIA:\n\nParticipants meeting any of the following criteria are not eligible for participation in the study:\n\n* Participants with CNS3 disease, progressing neurologic signs\\* of CNS disease, radiologically detected active CNS lymphoma (\\*resolving manifestation or persistent and\u002For irreversible findings from prior CNS involvement (e.g., blindness) is not exclusionary)\n* Hyperleukocytosis (\\>= 50,000 blasts\u002FmicroL)\n* Positive serum or urine beta-HCG pregnancy test performed at screening.\n* Participants will be excluded based on prior therapy if they fail to meet following washout criteria:\n\n  * Therapy: Systemic Chemotherapy, anti-neoplastic agents, antibody- based therapies\n  * Washout\\*: \\>=2 weeks\n  * Exceptions: 6 weeks for clofarabine or nitrosoureas; No washout for prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance-type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for participants with Ph+ ALL) provided there is recovery from any acute toxic effects\n  * Therapy: Radiation\n  * Washout\\*: \\>=3 weeks\n  * Exceptions: No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable\u002Fevaluable disease outside the radiation window\n  * Therapy: Allogeneic Stem Cell Transplant\n  * Washout\\*: \\>= 100 days since SCT; \\>= 30 days since completion of immunosuppression; \\>= 6 weeks since donor lymphocyte infusion (DLI)\n  * Exceptions: Cannot have evidence of active graft-versus-host disease (GVHD) requiring systemic immunosuppression\n  * Therapy: CAR T-Cell Therapy or other Adoptive Cell Therapy\n  * Washout\\*: \\> 30 days post infusion\n\n    * Washout: Time between therapy and apheresis\n* Positive HIV antibodies consistent with active HIV.\n* Positive hepatitis C antibodies or positive Hepatitis B surface antigen (HbsAG) indicative of current\u002Factive HCV\u002FHBV.\n* Active second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and participant is in remission.\n* History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells.\n* Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the participant.","ALL","3 Years","39 Years",{"count":20,"type":21},130,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nAcute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses.\n\nObjective:\n\nTo test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL.\n\nEligibility:\n\nPeople aged 3 to 39 with ALL or related B-cell lymphoma that has not been cured by standard therapy.\n\nDesign:\n\nParticipants will be screened. This will include:\n\nPhysical exam\n\nBlood and urine tests\n\nTests of their lung and heart function\n\nImaging scans\n\nBone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone.\n\nLumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord.\n\nParticipants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells.\n\nParticipants will receive chemotherapy starting 4 or 5 days before the CAR treatment.\n\nParticipants will be admitted to the hospital. Their own modified T cells will be returned to their body.\n\nParticipants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years....",[28,29,30,31,32,33,34,35,36,37,38],"B-NHL","B-Non Hodgkin Lymphoma","Acute Lymphocytic Leukemia","Acute Lymphoblastic Leukemia","B-precursor ALL","B-All","Lymphoma, Non-Hodgkin","Leukemia, Lymphocytic, B Cell","B-Cell Lymphoma","B-Cell Leukemia","Acute Lymphoid Leukemia",[40,41,42,43,44,33,32,31,30,29],"Philadelphia chromosome + ALL","Lymphoma","CD-22 Expressing Tumor","CD-19 expressing tumor","Adoptive Immunotherapy","RECRUITING","2026-06-30",{"date":48,"type":49},"2026-07-01","ACTUAL",{"date":51,"type":49},"2022-12-28",{"date":53,"type":21},"2029-07-01",{"name":55,"class":56},"National Cancer Institute (NCI)","NIH"]