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NCT00068003

Harvesting Cells for Experimental Cancer Treatments

Enrolling by Invitation
Not specifiedAges 18+Observational
National Cancer Institute (NCI)
~7,000 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Anti-CD19 CAR PBL

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Generating anti-tumor patient lymphocytes ex vivo
Measured over Approximately 20 years
+2 more outcomes measured

Conditions

Melanoma
Gastrointestinal Cancer
Metastatic Cancer
Breast Cancer
Non-Small Cell Lung Cancer

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NCT00068003

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Steven A Rosenberg, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Patients must have a form of cancer currently being studied in the NCI-SB.
Patient is able to understand and willing to sign a written informed consent document.
Age greater than or equal to 18 years.
Clinical performance status of ECOG 0 or 1.
Serology
Seronegative for HIV antibody. (The experimental treatments being evaluated depend upon an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities).
Seronegative for hepatitis B surface antigen and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
Lesions which will be harvested for the generation of TIL should be accessible via standard surgical or radiological techniques and be associated with acceptable morbidity.
Age greater than or equal to 18 years.
Non-reactive for HBsAg, anti-HBc, anti-HCV, anti-HIV-1/2, HBV/HCV/HIV-1 NAT, anti-HTLV-I/II, anti-T. cruzi, West Nile Virus NAT,syphilis, and babesia.
PBMC donors must meet the strict behavioral and medical history requirements as per applicable NCI-SB Apheresis Donor SOP(s).
Age greater than or equal to 18 years.

Exclusion

Active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system.
Patients who cannot give proper informed consent to the experimental therapy due to an active psychiatric disorder or inability to understand the nature of the proposed therapy and attendant risk.
Women of child-bearing potential who are pregnant because of the potentially dangerous effects of some of the procedures (e.g., tumor biopsy or surgery for tumor resection) on the fetus.
Has had babesiosis.
Is at risk or has Creutzfeldt-Jakob Disease.
Is on steroid therapy or any other medication or has received vaccination that might interfere with cell preparation per Principal Investigator s (PI) discretion.
Has ongoing illness that would cause harm to the volunteer during the apheresis procedure as determined by the PI.
Has had yellow jaundice, liver disease, or hepatitis since the age of 11.
Has uncontrolled diabetes.
Has a hematologic malignancy or any bleeding abnormalities.
Has received any type of organ transplant in the past 12 months.
Has undergone xenotransplantation at any time.
Has received a dura mater graft.
If female, is pregnant or has given birth within the last six weeks.
Has had an ear or body piercing or tattoos within the past 12 months.
Has had a blood transfusion within the past 12 months.
Has spent time outside the United States to a restricted country.
Has participated in any high-risk activities.

What this trial measures

  • Generating anti-tumor patient lymphocytes ex vivoApproximately 20 years

    Obtain allogeneic PBMC via apheresis, whole blood, or other blood products from healthy volunteers, for use in generating anti-tumor patient lymphocytes ex vivo.

  • To conduct genomic, proteomic, and immunologic research studiesApproximately 20 years

    Conduct genomic, proteomic, and immunologic research studies on samples collected from patients with a current diagnosis of cancer.

  • To obtain autologous blood, stem cells, and/or tumor tissue from patients currently with cancerApproximately 20 years

    Obtain autologous blood, stem cells, and/or tumor tissue from patients currently with cancer for laboratory analysis and ex vivo generation of autologous anti-tumor lymphocytes for potential future enrollment on an NCI-SB adoptive cell therapy clinical trial.