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Phase 1 Study of Autologous Natural Killer T Cells Infusion in Treating Patients With Tumors


N/A
18 Years
90 Years
Open (Enrolling)
Both
Breast Cancer, Glioma, Hepatocellular Cancer, Squamous Cell Lung Cancer, Pancreatic Cancer, Colon Cancer, Prostate Cancer

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Trial Information

Phase 1 Study of Autologous Natural Killer T Cells Infusion in Treating Patients With Tumors


A randomized controlled trial on the efficacy and safety of autologous natural killer T
(NKT) cells infusion treatment in advanced cancer.


Inclusion Criteria:

•Male or female not less than 18 years of age or over 80 years of age.

- Life expectancy of ≥ 24 weeks as measured by the Eastern Cooperative Oncology Group
(ECOG) performance status.

- Subjects must present with one of the following disease pathologies: Breast Cancer,
Glioma, Hepatocellular Cancer, Squamous Cell Lung Cancer, Pancreatic Cancer, Colon
Cancer or Prostate Cancer

- The pathology must be an assessable disease (measurable by CT scan or MRI) that is
refractory to standard treatments (e.g., chemotherapy, radiation, etc.)

- Negative for hepatitis B, hepatitis C, HIV, and CMV.

- Subjects must present with leukocyte counts above 3,000/μL and platelet counts above
100,000/ μL.

- Subjects must present with minimum hemoglobin levels of 10.

- If female, subject is surgically sterile (hysterectomy, bilateral tubal ligation, or
bilateral oophorectomy), post menopausal (no menses >12 months), or using a
high-efficiency method of contraception such as implant, injectable, combination oral
contraceptive, intrauterine device (IUD) or sexual abstinence, or has a vasectomized
partner.

- If female of childbearing potential, subject is not pregnant, breast-feeding or
planning a pregnancy during the study, and has a negative pregnancy test on screening
visit.

- Able to comprehend and sign an informed consent document and comply with the
requirements of the study.

Exclusion Criteria:•No measurable malignant disease by CT scan or tumor markers.

- Life expectancy of ≤ 24 weeks as measured by the Eastern Cooperative Oncology Group
(ECOG) performance status.

- Age of less than 18 years or over 80 years of age.

- Documented/confirmed positive testing for hepatitis B, hepatitis C, HIV, or CMV.

- Prior or current history of autoimmune disease.

- Pregnant or lactating women.

- Leukocyte count < 3,000 /μL prior to leukapheresis.

- Platelet count < 100,000/μL prior to leukapheresis.

- Hemoglobin levels below 10.

- PTT (prothrombin time) of < 12 seconds or > than 15 seconds.

- aPTT (activated partial thromboplastin time) of < 25 seconds or > than 39 seconds.

- Failure or refusal to sign informed consent for the study.

- Culture fails to meet specifications for study.

- Subject has any other medical condition that, in the opinion of the investigator,
might significantly affect the ability to safely participate in the study or affect
the conduct of the study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of study related adverse events

Outcome Description:

defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment

Outcome Time Frame:

Until week 24

Safety Issue:

Yes

Authority:

China: Ethics Committee of Chinese PLA General Hospital

Study ID:

CHN-PLAGH-BT-003

NCT ID:

NCT01801852

Start Date:

January 2013

Completion Date:

June 2017

Related Keywords:

  • Breast Cancer
  • Glioma
  • Hepatocellular Cancer
  • Squamous Cell Lung Cancer
  • Pancreatic Cancer
  • Colon Cancer
  • Prostate Cancer
  • Breast Neoplasms
  • Colonic Neoplasms
  • Glioma
  • Liver Neoplasms
  • Lung Neoplasms
  • Pancreatic Neoplasms
  • Prostatic Neoplasms

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