Ann: Second Dose Cohort Initiated in CLTX CAR T Phase 1 Trial, page-6

Yes very encouraging......deduct their cash backing - legitimately convert to US dollars, for Pharma discussion purposes ....IMU etc. Really good.

Also from that Clinical.Trials.gov -  this is the highly sophisticated biomarker studies.... these days, of how patient progress is monitored.


Secondary Outcome Measures :

1. Chimeric antigen receptor (CAR) T cell [ Time Frame: 15 years ]
   Will assess its levels and phenotype detected in tumor cyst fluid (TCF), peripheral blood (PB), and cerebrospinal fluid (CSF) (absolute number per ul by flowcytometry). Statistical and graphical methods will be used.
2. Endogenous T cell [ Time Frame: 15 years ]
   Will assess its level and phenotype detected in TCF, PB, and CSF (absolute number per ul by flowcytometry). Statistical and graphical methods will be used.
3. Cytokine levels in TCF, PB and CSF [ Time Frame: 15 years ]
4. Progression free survival time [ Time Frame: At 6 months ]
5. Disease response [ Time Frame: At 6 months ]
   Will be assessed by modified Response Assessment in Neuro-Oncology Criteria (RANO) criteria with the need for bevacizumab as an additional indicator of progression.
6. Overall survival (OS) [ Time Frame: At 9 months ]
   Kaplan Meier methods will be used to estimate median OS and graph the results.
7. CAR T cells detected in tumor tissue [ Time Frame: 15 years ]
   Will be assessed by immunohistochemistry.
8. Chlorotoxin-targeted antigen expression levels in tumor tissue [ Time Frame: 15 years ]
   Will assess the pathology H score.
9. Biomathematical modeling of tumor growth [ Time Frame: 15 years ]
   Will assess perfusion and growth parameters based on serial brain magnetic resonance imaging (MRI)s.