CCT301-38 CAR-T in Patients With Relapsed or Refractory AXL Positive Sarcomas (NCT05128786) | Clinical Trial Compass
TerminatedPhase 1
CCT301-38 CAR-T in Patients With Relapsed or Refractory AXL Positive Sarcomas
Stopped: Adjustment of study strategy
China9 participantsStarted 2021-12-30
Plain-language summary
This clinical study is to investigate the safety and tolerability of CCT301-38 CAR modified autologous T cells (CCT301-38) in subjects with relapsed or refractory AXL positive sarcomas
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Patients with willingness to be in the study and follow all study procedures, and capable of providing informed consent
✓. Male or female aged 18-70 years;
✓. Patients with unresectable, locally advanced or metastatic relapse/refractory sarcomas that have failed at least the front line standard treatment confirmed by histology or cytology;
✓. At least one measurable lesion, i.e. the length of non-lymph node lesions examined according to CT cross-sectional scanning or magnetic resonance imaging (MRI), or the short diameter of the lymph node lesions is ≥15 mm according to RECIST 1.1, and the FDG PET signal from the measurable lesion is \> 3 SUV;
✓. Tumors with AXL positive (IHC 1+ or greater) in ≥50% of all tumor cells. A new biopsy is required if the sample is over one year.
✓. ECOG Performance Status 0-1;
✓. Expected survival greater than 12 weeks;
✓. Adequate organ and hematopoietic system functions to meet the following requirements:
Exclusion criteria
✕. Females with pregnancy or in lactation period;
✕. Subjects with active hepatitis B, or active hepatitis C. Subjects with undetectable HBV DNA or HCV RNA after anti-virus treatment can be enrolled;
. Other active infections of clinical significance;
✕. Subjects with the following previous or accompanying diseases:
✕. Patients with previous diagnosis as motor neuron disease caused by autoimmunity;
✕. Patients previously suffered from toxic epidermal necrolysis (TEN)
✕. Patients with any mental illness, including dementia, mental changes, which may cause difficulties understanding the informed consent and related questionnaires;