Enrolling By InvitationNot applicableNCT00068003
Official study title

Harvesting Cells for Experimental Cancer Treatments

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedAnti-CD19 CAR PBL

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 16, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Enrolling By Invitation

Participation is limited to people invited by the study team.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?National Cancer Institute (NCI)

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
National Cancer Institute (NCI)
Interventions being studied
Drug: Anti-CD19 CAR PBL
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • ELIGIBILITY CRITERIA FOR PATIENTS WITH A CURRENT DIAGNOSIS OF CANCER:
  • 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.
Reasons someone may not be able to joinExclusion criteria
  • 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. ELIGIBILITY CRITERIA FOR HEALTHY VOLUNTEERS: INCLUSION CRITERIA for PBMC Donors:
  • 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). INCLUSION CRITERIA FOR WHOLE BLOOD DONORS:
  • Age greater than or equal to 18 years.
  • Whole blood donors must meet the DTM inclusion criteria for allogeneic whole blood donation.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • National Institutes of Health Clinical CenterBethesda, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 16, 2026. Always confirm current availability with the study team.

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