HS-IT201 Injection in the Treatment of Advanced Solid Tumors
ConditionSolid Tumor
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQingdao Sino-Cell Biomedicine Co., Ltd.
About this trial
Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT201) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor.
Eligibility criteria
Qualifiers
Age: 18 years to 75 years at the time of consent;
Diagnosis by cytology or histology, failure to standard treatment (including disease progression and/or adverse reactions are not tolerated) or are judged by the investigator to be unsuitable for the use of existing standards Treatment methods for patients with advanced solid tumors, including but not limited to kidney cancer, non-small cells Lung cancer, stomach cancer, colorectal cancer, melanoma, etc. Participants are required to have a minimum of menstruation Through first-line treatment.
At least one resectable lesion that has not received radiotherapy or other local therapy within 28 days, and the weight of the tissue must be ≥ 0.050g；or resectable lesions capable of producing sufficient TIL;
At least one measurable target lesion, as defined by RECIST v1.1，that has not received radiotherapy or other local therapy unless these therapies occurred 28 days ago and target lesion shows significant progression;
Disqualifiers
Test subjects who have a history of hypersensitivity to any component or excipient of HS-IT101 or other study drugs (cyclophosphamide, fludarabine and recombinant human interleukin-2);
Test subjects who have active major medical illnesse(es) of the cardiovascular (within 6 months prior to enrollment), including deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient cerebral ischemia Seizures, cerebral embolism;
Active autoimmune diseases that require systemic treatment during the study period (eczema, vitiligo, psoriasis, alopecia or Grave's disease that do not require systematic treatment in the past two years, other autoimmune diseases that are not expected to recur, hypothyroidism that only requires thyroid hormone replacement therapy, and type I diabetes subjects that only require insulin replacement therapy can be included);
Organ transplantation and a history of hematopoietic stem cell transplantation;
Trial design
Treatments tested in this trial
- HS-IT201 Injection
Treatment groups
9 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Qingdao Sino-Cell Biomedicine Co., Ltd.
Lead sponsor
The Affiliated Hospital of Qingdao University
Collaborator
Source ClinicalTrials.gov