Clinical trial · Interventional
Safety Study of Adoptive Transfer of Autologous IKDC-like Cells
An Immunotherapy for Metastatic Cancer Patients by Adoptive Transfer of Autologous IKDC-like Cells - Phase 1 Clinical Trial
NCT02661685CI-TRIAL-00050135completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety of adoptive transferring autologous IKDC-like cells
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous IKDC-like cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- autologous IKDC-like cell
- description
- Received autologous IKDC-like cells
- interventionNames
- Biological: autologous IKDC-like cells
Primary outcomes (1)
- measure
- Evaluation of subject with Grade 3 or above adverse events that received autologous IKDC-like cells, graded according to NCI-CTCAE v4.03
- timeFrame
- Through study complete, an average about 1.5 years
- description
- I. Safety is evaluated by assessment of does-limiting toxicity (DLT) according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 or above. II. DLT is defined as follows: * Any Grade 3 or above toxicity regarding general disorders or immune disorders defined by NCI-CTCAE is determined by the investigator to be possibly related in causality to the treatment. * Fever, chillness, flu-like symptoms, or infusion-related reactions of grade 3 or more are to be counted as DLT only if they remain at grade 3 or more for more than three days despite of adequate symptomatic medications.. III. The maximum tolerated dose (MTD) of autologous IKDC-like cell will be determined via a 3+3 traditional design.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic/recurrent non-hematological cancer, stage IV at study entry. * Age: 21-75 years. * ECOG performance status 0-1. * Patients must have at least one measurable lesion. * Patients' disease must have failed at least one-line of standard chemotherapy/targeted therapy or other treatment in the metastatic setting. * Patients' estimated life expectancy is more than 3 months. * Patients who refuse chemotherapy, or who are physiologically unsuitable for chemotherapy or any other standard therapy per investigator's discretion will be considered eligible for this trial. * Patients must have adequate bone marrow function, defined as WBC ≥ 3500/mm3, neutrophil ≥ 1500/mm3, lymphocyte ≥ 1,000/mm3, and platelet ≥ 100,000/mm3. * Patients must have adequate liver and renal function, defined as serum alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 5 times normal, bilirubin ≤ 1.5 times normal range, and creatinine ≤ 1.5 times upper normal limit. * All patients should have documentation of negative result of penicillin test. * Women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. * All patients must be informed of the investigational nature of this study and must sign and give written informed consent. Exclusion Criteria: * Subjects with metastatic cancer in disease progression (expected survival time \< 3 months). * Subjects who have had chemotherapy less than 4 weeks before the start of trial. * Subjects who received IFN-γ or GM-CSF less than 4 weeks before the start of trial. * Subjects who are HIV, HBV, or HCV positive. * Patients who have central nervous system metastasis except for those whose CNS disease have been treated with radiotherapy (Disease-free \> 6 months) and/or surgery and have been stable for at least two weeks. * Patients who have active acute or chronic infection (at the discretion of the investigator). * Pregnant or breast-nursing women. * Patients who have active cardiac disease requiring therapy for failure, angina, arrhythmia, or infarction within the preceding 6 months (exception: any patient whose cardiac failure is compensated on medications). * Subjects who have received corticosteroids or other immunosuppressive agents less than 4 weeks before starting trial. * Subjects who have asthma and/or are on treatment for asthma. * Subjects with history of autoimmune disease, such as lupus, multiple sclerosis, Ankylosing Spondylitis, Systemic Sclerosis. * Subjects with a history of other systemic disease.. * History of neoplastic disease within the last 5 years except for carcinoma in situ of the cervix, superficial bladder cancer or basal/squamous cell carcinoma of the skin. * Subjects who present with open wounds.
References
Publications (37)
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- BACKGROUNDVesely MD, Kershaw MH, Schreiber RD, Smyth MJ. Natural innate and adaptive immunity to cancer. Annu Rev Immunol. 2011;29:235-71. doi: 10.1146/annurev-immunol-031210-101324. PMID 21219185
- BACKGROUNDGalon J, Angell HK, Bedognetti D, Marincola FM. The continuum of cancer immunosurveillance: prognostic, predictive, and mechanistic signatures. Immunity. 2013 Jul 25;39(1):11-26. doi: 10.1016/j.immuni.2013.07.008. PMID 23890060
- BACKGROUNDFridman WH, Pages F, Sautes-Fridman C, Galon J. The immune contexture in human tumours: impact on clinical outcome. Nat Rev Cancer. 2012 Mar 15;12(4):298-306. doi: 10.1038/nrc3245. PMID 22419253
- BACKGROUNDChen DS, Mellman I. Oncology meets immunology: the cancer-immunity cycle. Immunity. 2013 Jul 25;39(1):1-10. doi: 10.1016/j.immuni.2013.07.012. PMID 23890059
- BACKGROUNDRosenberg SA, Yang JC, Sherry RM, Kammula US, Hughes MS, Phan GQ, Citrin DE, Restifo NP, Robbins PF, Wunderlich JR, Morton KE, Laurencot CM, Steinberg SM, White DE, Dudley ME. Durable complete responses in heavily pretreated patients with metastatic melanoma using T-cell transfer immunotherapy. Clin Cancer Res. 2011 Jul 1;17(13):4550-7. doi: 10.1158/1078-0432.CCR-11-0116. Epub 2011 Apr 15. PMID 21498393
- BACKGROUNDKochenderfer JN, Rosenberg SA. Treating B-cell cancer with T cells expressing anti-CD19 chimeric antigen receptors. Nat Rev Clin Oncol. 2013 May;10(5):267-76. doi: 10.1038/nrclinonc.2013.46. Epub 2013 Apr 2. PMID 23546520