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Enrolling by invitationPhase 1/2

Tests modified immune cells against cholangiocarcinoma and neuroblastoma

Tests modified immune cells in patients with bile duct or nerve tumors.

Key facts

Who runs it
Siriraj Hospital
Where
Bangkok and Bangkoknoi, ThailandSee the 2 sites
Trial code
Registry title
The Adoptive Immunotherapy for Solid Tumors Using Modified Autologous CIK Cells
Status
Enrolling by invitation
Phase
Phase 1/2
People taking part
20 people, planned
Started
17 Apr 2009
Expected to end
30 May 2028
Type of study
Interventional
Treatments tested
  • cytokine induced killer cells
Record updated
10 February 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 8 to 60 with advanced cholangiocarcinoma (bile duct cancer) or neuroblastoma that has not responded to current treatment.

Age
8 to 60 years. A parent's permission is needed if the person is younger than 8.
Sex
Men and women can join.
Disease stage
Advanced cholangiocarcinoma or neuroblastoma, confirmed by tissue or cell tests. The cancer has failed current treatment. ECOG performance status of 0, 1 or 2. Life expectancy of at least 12 weeks.
Earlier treatment
The cancer has failed current treatment. Chemotherapy within 4 weeks before entry is not allowed.
Biomarker or test result
Blood tests: Hb > 8 g/dl, ANC > 1,500 cells/mm3, lymphocytes > 1,000 cells/mm3, platelets > 100x109/L, bilirubin < 3 mg/dl, creatinine < 2 mg/dl (177 µmol/L).

Main reasons for not taking part

  • Chemotherapy within 4 weeks before entry
  • Active infection that is not controlled
  • Other investigational cancer treatment, including immunotherapy, in the last 30 days
  • Pregnant or breastfeeding, or a positive urine pregnancy test
  • Steroid treatment at the same time

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Patient must be at least 8 year-old, or allowance from their parent if younger than that
  • Patient must have histologically or cytologically confirmed advanced cholangiocarcinoma or neuroblastoma by oncologist
  • The cancers have been failing to current treatment
  • Patient is healthy by getting an Eastern Co-operative Oncology Group (ECOG) performances status of 0, 1 or 2
  • Any of the following lab data; Hematology:; Hb > 8 g/dl; Absolute neutrophil count (ANC) > 1,500 cells/mm3; Absolute lymphocyte count > 1,000 cells/mm3; Platelet > 100x109/L
  • Patient must have a life expectancy of at least 12 weeks by; Biochemistry:; Serum total bilirubin < 3 mg/dl; Serum creatinine < 2 mg/dl
  • Patients will comply and provide written informed consent prior to enrollment into the study

Who cannot take part

  • Patients received chemotherapy within 4 weeks before study entry
  • Concurrent anti-cancer treatment in another investigational trial, including immunotherapy in last 30 days
  • Concurrent steroid therapy
  • Active uncontrolled infection
  • Pregnant or lactating woman, or women of child bearing potential or less than one year after menopause (unless surgically sterile) with urine pregnancy test positive

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 8 and 60 years old?

Where in Thailand

  • Faculty of Medicine Siriraj Hospital, Mahidol UniversityBangkok, ThailandNo longer taking part
  • Siriraj Clinical Research Center, Siriraj HospitalBangkoknoi, ThailandNo longer taking part

About the trial

What the trial wants to find out

Cytokine-induced killer (CIK) cells exhibit high proliferation rate and cytotoxic activity in vitro. The major effector cells are the CD3+CD56+ subset. The cytolytic activity of CIK cells being independent of MHC restriction implies feasibility in using CIK cells allogeneic to the tumors. Experiments to block the MHC class-I and -II pathways on tumors-RNA transfected DCs showed that only MHC class-I blocking led to a significant reduction of heterogeneous CIK cells cytotoxicity after the co-culture. The safety of CIK cells was demonstrated by the lack of cytotoxicity toward autologous as well as allogeneic normal cells. Co-culture of CIK cells with dendritic cells (DCs) has been reported by us and others in a myriad of cancer (e.g., cholangiocarcinoma, osteosarcoma, glioblastoma multiforme, multiple myeloma, hepatocellular carcinoma, pancreatic carcinoma, renal \& colon carcinoma, murine leukemia \& lymphoma showing enhancement of anti-tumor cytotoxicity of CIK cell in all. The co-culture of CIK cells with DCs were reported to decrease the number of professional regulatory/ suppressor T cells (Treg, CD4+CD25+ cells) and decrease the secretion of IL-10, an immune suppressor cytokine, whereas the cytotoxic activity against target cells increased.

Read full original descriptionShow less

We have recently brought CIK cells through the preclinical phase (animal study) of human cholangiocarcinoma treatment. Cholangiocarcinoma (CCA), is a bile duct epithelial cancer endemic in the Northeast of Thailand, with an increasing incidence discernible in Europe and North America. Conventional treatments including surgery, chemotherapy, and radiation do not bring satisfactory survival due to anatomic location, presence of metastases, and high recurrent rates. These unsatisfactory outcomes urge to search innovative treatments such as immunotherapy. We reported the safety and efficacy of CIK cells in SCID mice model for cholangiocarcinoma. Several conditions of human CIK cells were examined using ex vivo cytotoxic assay and SCID mice pre-inoculated with human cholangiocarcinoma cells. We monitored the ex vivo cytotoxicity, tumor sizes and immunohistochemistry. Optimal tumor suppression was observed when CIK cells were pre-exposed to dendritic cells (DCs). Tumor-infiltrating human CD3+ cells were observed from day 2 - 14, but not in normal tissues elsewhere. These altogether indicated the specific homing of CIK cells to tumor mass. All animals did not exhibit any noticeable adverse reaction from the CIK treatments. The CD3+CD56+ cells are logical candidates for clinical trial while the DC-co-cultured CIK cells produced similar efficacy and more feasible for clinical application.

With a complete array of in vitro and in vivo study, the next rational step is moving forward to phase I/II clinical trials for a number of specified solid tumors (i.e., cholangiocarcinoma, osteosarcoma, and glioblastoma multiforme, nueroblastoma) using the optimized autologous CIK cells. Subjects without prior exposure to or weaned for at least 3 months from chemotherapy can be recruited to maintain the integrity of their immunological system, a critical factor for a successful immunotherapy.

The group in the trial

  • drugTreatment being tested

    single-group studies

    Treatment: cytokine induced killer cells

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

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

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Phase 1 Study of The Adoptive Immunotherapy for Solid Tumors Using Modified Autologous Cytokine-induced Killer Cells.
Plain-language title
Tests modified immune cells against cholangiocarcinoma and neuroblastomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT01868490, who can take part
Record updated
10 February 2025