A Phase I Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors
Tumor infiltrating lymphocytes were isolated from tumor tissues from tumor biopsy or
operation. These TILs were cultured in human IL-2 medium for 2 to 3 weeks, and reactivated
by OKT3, irradiated feeder cells from the PBMCs of healthy donors and LCL set from
EBV-transformed normal B cells, and expanded in human IL-2 medium for another 15 days. 10e9
to 10e10 TILs were yielded. The phenotype, function and sterile were detected before these
TILs infused patients. After accepting operation or first round of routine chemotherapy and
radiotherapy, the patients were treated with autologous TILs 10e9-10e10 via intravenous in
30 min, q weekX2 weeks, and followed by two weeks with daily sc low-dose interleukine-2.
Patients will be evaluated for toxicity and immune response. Peripheral blood of patients
using multimer analysis and/or ELISPOT assays. Additional, we will be able to determine
anti-tumor effects from immunotherapy by evaluating the clinical response of patients with
stable or progressive disease at the time of TILs infusion. Lastly, we will assess
additional tumor markers in patients with relapsed/refractory disease by immunohistochemical
staining of tumor sections from previous diagnostic or therapeutic biopsy samples to
determine the incidence of additional tumor antigen targets that may be used in future
studies.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• the safety and tolerability of autologous tumor infiltrating lymphocytes (TIL) in combination with Interleukin-2(IL-2) in patients with nasopharyngeal carcinoma (NPC).
Safety and tolerability will be assessed by looking at adverse events by standard NIH criteria and also by performing a Quality of Life assessment. Adverse events will be reported on the case report form. The problility of observing at least one subject experience an adverse event in a sample of 20 subjects is 0.99, if the probability of the event occurring is assumed to be 0.2. There will be 95% power to detect a change in the proportion of adverse events in the group from 0 before treatment to 0.2 after treatment.
{Time Frame: 12 months}
Yes
Yi-Xin Zeng, Ph.D.
Principal Investigator
Sun Yat-sen University
China: Food and Drug Administration
SenU-200902002-2
NCT01462903
September 2011
December 2013
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