Clinical trial · Interventional
In Vitro Expanded Autologous Invariant Natural Killer Cells in Cancer
A Phase I Trial of in Vitro Expanded Autologous Invariant Natural Killer Cells in Cancer
- 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 research study is to determine whether we can purify and grow a population of cells from the participants blood (iNKT cells) and then safely give them back to the participant in increased numbers, and whether these cells will then stimulate the bodies own immune response against the cancer. These iNKT cells have been used in laboratory studies and information from these and other research studies suggest that increasing the number of these cells in the blood can stimulate the immune response against tumors.
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 |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF | Drug | — | UNRESOLVED |
| INKT | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- GM-CSF +INKT
- description
- INKT will be administered in 3 equal doses by intravenous infusion on days 1, 15 and 29. GM-CSF will be given subcutaneously once daily for 10 days beginning the second day of the second and third infusion
- interventionNames
- Biological: INKT
- Drug: GM-CSF
Primary outcomes (2)
- measure
- To determine the feasibility of isolating and expanding in vitro autologous iNKT cells from cancer patients for therapeutic use.
- timeFrame
- 2 years
- measure
- To assess the safety of treatment with in vitro expanded autologous iNKT cells alone, and in conjunction with GM-CSF.
- timeFrame
- 2 years
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage IV melanoma * ECOG Performance Status 0-1 * Estimated life expectancy of 6 months or greater * 18 years of age or older * Adequate renal, hepatic and hematological function as outlined in protocol * Adequate pulmonary and cardiac function as outlined in protocol * Prior therapies must be discontinued at least 4 weeks prior to the leukopheresis to obtain iNKT cells. This does not include palliative surgery or radiation therapy, which may be used prior to leukopheresis or during the interval between leukopheresis and iNKT cell reinfusion * Melanoma patients must not have brain metastases based on a negative MRI obtained within 4 weeks prior to screening, and must not have a history of brain metastases * No other significant medical, surgical or psychiatric condition that, in the judgment of the PI, would interfere with compliance to the protocol regimen Exclusion Criteria: * Pregnant or nursing women * Active systemic infection, positive HIV, HBV, or HCV serology, or immune deficiency disease * Autoimmune disease that currently requires systemic therapy with immunosuppressive agents * Known hypersensitivity to GM-CSF or DMSO * Other active malignancy other than squamous cell or basal cell of the skin
References
Publications (0)
Data not yet available