Last reviewed · How we verify

NCT00068003

Harvesting Cells for Experimental Cancer Treatments

ENROLLING BY INVITATION Last updated 14 April 2026
What this trial tests

trial testing Anti-CD19 CAR PBL in Melanoma in 7,000 participants. Enrolling by invitation.

Timeline
8 September 2003

Quick facts

Lead sponsorNational Cancer Institute (NCI)
StatusENROLLING BY INVITATION
Study typeOBSERVATIONAL
Enrollment7,000
Start date8 September 2003
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Melanoma or Gastrointestinal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Adoptive Cellular Therapy with Autologous Tumor-Infiltrating Lymphocytes and T-cell Receptor-Engineered T Cells Targeting Common p53 Neoantigens in Human Solid Tumors.
    Kim SP, Vale NR, Zacharakis N, Krishna S, et al · · 2022 · cited 151× · PMID 35749374 · DOI 10.1158/2326-6066.cir-22-0040
  2. Breast Cancers Are Immunogenic: Immunologic Analyses and a Phase II Pilot Clinical Trial Using Mutation-Reactive Autologous Lymphocytes.
    Zacharakis N, Huq LM, Seitter SJ, Kim SP, et al · · 2022 · cited 148× · PMID 35104158 · DOI 10.1200/jco.21.02170
  3. Immunology and immunotherapy of cholangiocarcinoma.
    Greten TF, Schwabe R, Bardeesy N, Ma L, et al · · 2023 · cited 138× · PMID 36697706 · DOI 10.1038/s41575-022-00741-4
  4. Phenotypic signatures of circulating neoantigen-reactive CD8<sup>+</sup> T cells in patients with metastatic cancers.
    Yossef R, Krishna S, Sindiri S, Lowery FJ, et al · · 2023 · cited 54× · PMID 38039963 · DOI 10.1016/j.ccell.2023.11.005
  5. Neoantigen Identification and Response to Adoptive Cell Transfer in Anti-PD-1 Naïve and Experienced Patients with Metastatic Melanoma.
    Levi ST, Copeland AR, Nah S, Crystal JS, et al · · 2022 · cited 51× · PMID 35247926 · DOI 10.1158/1078-0432.ccr-21-4499
  6. Using patient-derived tumor organoids from common epithelial cancers to analyze personalized T-cell responses to neoantigens.
    Parikh AY, Masi R, Gasmi B, Hanada KI, et al · · 2023 · cited 26× · PMID 37368077 · DOI 10.1007/s00262-023-03476-6
  7. Proteogenomic Analysis Unveils the HLA Class I-Presented Immunopeptidome in Melanoma and EGFR-Mutant Lung Adenocarcinoma.
    Qi YA, Maity TK, Cultraro CM, Misra V, et al · · 2021 · cited 26× · PMID 34391887 · DOI 10.1016/j.mcpro.2021.100136
  8. Neoantigen-specific stimulation of tumor-infiltrating lymphocytes enables effective TCR isolation and expansion while preserving stem-like memory phenotypes.
    Levin N, Kim SP, Marquardt CA, Vale NR, et al · · 2024 · cited 21× · PMID 38816232 · DOI 10.1136/jitc-2023-008645

Verify or expand the search:

Other recruiting trials for Melanoma

Currently open trials in the same condition.

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00068003.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing