protocolSection identificationModule nctId: NCT06364423, orgStudyIdInfo id: 10001599, secondaryIdInfos id: 001599-C, briefTitle: Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-07-01, completionDateStruct date: 2030-07-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: Background:Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. CD19 is a protein often found on the surfaces of these cancer cells. Researchers can modify a person's own immune cells (T cells) to target CD19. When these modified T cells are returned to the body-a treatment called anti-CD19 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells.Objective:To test anti-CD19 CAR T cell therapy in people with CLL or SLL.Eligibility:People aged 18 years and older with CLL or SLL that has not been controlled with standard drugs.Design:Participants will be screened. They will have imaging scans and tests of their heart function. If a sample of tissue from their tumor is not available, a new one may be taken; the sample will be tested for CD19.Participants will receive a drug to reduce the leukemia cells in their blood. Then they will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be gene edited to make them attack cells with CD19.Participants will take drugs to prepare them for treatment for 3 days. These drugs will start 5 days before the treatment. Then their own modified CAR T cells will be returned to their bloodstream. Participants will stay in the hospital for at least 9 days after the treatment.Follow-up visits will continue for 5 years., conditionsModule conditions: B-Cell Chronic Lymphocytic Leukemia, conditions: Leukemia, Lymphocytic, Chronic, B-Cell, conditions: B-Lymphocytic Leukemia, Chronic, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Autologous HuCD19 ( Anti-CD19)CAR T cells, interventions name: Cyclophosphamide, interventions name: Fludarabine, interventions name: Rituximab, outcomesModule primaryOutcomes measure: Phase I: Determine the safety of administering T-cells expressing a fully-human anti-CD19 CAR to participants with advanced CLL or SLL., primaryOutcomes measure: Phase II: Determine the overall response rate (ORR) of T cells expressing an anti-CD19 CAR with a fully-human single chain variable fragment (scFv) to participants with advanced CLL, secondaryOutcomes measure: Phase I: Assess overall response rate, secondaryOutcomes measure: Phase I+II: Assess complete response rate, secondaryOutcomes measure: Phase I+II: Assess duration of responses, secondaryOutcomes measure: Phase I+II: Determine the ORR for re treatment with rituximab, chemotherapy and CAR T cells in eligible patients, secondaryOutcomes measure: Phase II: Determine the frequency of grade 3-4 adverse events at the Optimal Dose, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institutes of Health Clinical Center, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: NCI Medical Oncology Referral Office, role: CONTACT, phone: 240-760-6050, email: ncimo_referrals@nih.gov, contacts name: Micaela Ganaden, M.D., role: CONTACT, phone: (240) 858-3654, email: ncicar@mail.nih.gov, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False