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Melanoma / Metastatic Cancer / Anti-CD19 CAR PBL · Observational Study
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for an ongoing National Cancer Institute observational study designed to harvest and culture white blood cells and tumor tissue from cancer patients and normal volunteers for experimental cell therapies. No clinical outcomes or efficacy data are reported in this registry entry; it documents only the planned enrollment (7000 participants), procedural endpoints (cell generation, genomic and immunologic analysis), and study structure.
Observational. Melanoma, Gastrointestinal Cancer, Metastatic Cancer, Breast Cancer, Non-Small Cell Lung Cancer; age from 18 Years; accepts healthy volunteers. Intervention: 1/Cancer Patients; 2/Healthy Volunteers. n = 7,000. 1 site: United States.
Estimated enrollment: 7000 participants across melanoma, gastrointestinal cancer, metastatic cancer, breast cancer, and non-small cell lung cancer Primary outcome measures include generating anti-tumor patient lymphocytes ex vivo and conducting genomic, proteomic, and immunologic research studies over approximately 20 years Study collects white blood cells from normal volunteers and white blood cells and/or tumor cells from eligible cancer patients for laboratory expansion and autologous reinfusion
No follow-up data or adverse event summaries provided in registry entry
This registry record documents an ongoing cell-collection and expansion program but reports no clinical efficacy, safety, or outcome data. Clinicians should not interpret this registry entry as evidence of treatment benefit; results from downstream treatment protocols using these cells must be consulted separately.
This is a registry record for an ongoing observational cell-harvesting study with no reported results; it describes planned enrollment and procedural outcomes only, not clinical efficacy or safety data.
As stated by the source record.
Quoted from the source exactly as published.
This registry record documents an ongoing cell-collection and expansion program but reports no clinical efficacy, safety, or outcome data. Clinicians should not interpret this registry entry as evidence of treatment benefit; results from downstream treatment protocols using these cells must be consulted separately.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT00068003). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: ENROLLING_BY_INVITATION. Study type: OBSERVATIONAL. Enrollment: 7000 participants (ESTIMATED). Conditions: Melanoma, Gastrointestinal Cancer, Metastatic Cancer, Breast Cancer, Non-Small Cell Lung Cancer. Interventions: DRUG: Anti-CD19 CAR PBL. Primary outcome measures: Generating anti-tumor patient lymphocytes ex vivo , Approximately 20 years; To conduct genomic, proteomic, and immunologic research studies , Approximately 20 years; To obtain autologous blood, stem cells, and/or tumor tissue from patients currently with cancer , Approximately 20 years. Brief summary: Background: The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will collect white blood cells from normal volunteers and white blood cells and/or tumor cells, from patients who have been screened for and are eligible for a NCI Surgery Branch treatment protocol. The cells collected from normal volunteers will be used as growth factors for the cells during the period of laboratory growth. The cells and/or tumor from patients will be used to make the cell treatment product. Eligibility: Patients must be eligible for a NCI Surgery Branch Treatment Protocol Normal Volunteers must meet the criteria for blood donation Design Both patients and normal Volunteers will undergo apheresis. Patients will then undergo further testing as required by the treatment protocol. There is no required follow up for normal volunteers.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.