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Harvesting Cells for Experimental Cancer Treatments

A legfontosabb adatok

Ki végzi
National Cancer Institute (NCI)
Hol
Bethesda (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Csak meghívásos
Résztvevők
7000 fő, tervezett
Kezdés
2003. szept. 8.
A vizsgálat típusa
Megfigyeléses, 2 csoport
A vizsgált kezelések
  • Anti-CD19 CAR PBL
A regiszteradat frissítve
2026. november 12.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Részt vehetnek

A regiszter feltételei, szó szerint

Mind a 31 feltétel megnézéseKevesebb

Ki vehet részt

  • 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
  • Whole blood donors must meet the DTM inclusion criteria for allogeneic whole blood donation

Ki nem vehet részt

  • 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:
  • 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 received any type of organ transplant in the past 12 months
  • Has received a dura mater graft
  • 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
  • Is at risk or has Creutzfeldt-Jakob Disease
  • Has ongoing illness that would cause harm to the volunteer during the apheresis procedure as determined by the PI
  • Has uncontrolled diabetes
  • Has a hematologic malignancy or any bleeding abnormalities
  • Has had yellow jaundice, liver disease, or hepatitis since the age of 11
  • Has had babesiosis
  • Has undergone xenotransplantation at any time
  • 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
  • Whole blood donors who do not meet the DTM criteria for allogeneic whole blood donation

Egyéb feltételek

  • ELIGIBILITY CRITERIA FOR PATIENTS WITH A CURRENT DIAGNOSIS OF CANCER:

Helyszínek itt: Egyesült Államok

  • National Institutes of Health Clinical CenterBethesda, Egyesült ÁllamokNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

Background:

A teljes eredeti leírásKevesebb

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.

...

A vizsgálat 2 csoportja

  • 1/Cancer Patients

    Patients with a current diagnosis of cancer

    Kezelés: Anti-CD19 CAR PBL

  • 2/Healthy Volunteers

    Healthy volunteers

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Cell Harvest and Preparation for Surgery Branch Treatment Protocols
A regiszteradat frissítve
2026. november 12.