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
This study is an open label, single-center Phase I dose escalation trial to assess the safety, tolerability, DLT and MTD of CCT301-38 cell therapy in patients with AXL positive relapsed or refractory sarcomas. Subjects that meet inclusion criteria with positive AXL biopsy (IHC 1+ or greater in ≥50% tumor cells) will receive CCT301-38 according to the 3+3 dose escalation design.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Blood will be collected from subjects to isolate peripheral blood mononuclear cells for the production of CCT301-38. Subjects will receive the conditioning chemotherapy regimen of cyclophosphamide and fludarabine for lymphodepletion followed by a single or multiple dose of CCT301-38 via intravenous injection.
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
DLT
To assess the safety and tolerability of CCT301-38 cell therapy for patients with AXL-positive (IHC 1+ or greater in ≥50% tumor cells) relapsed or refractory sarcomas.
Time frame: 28 days following infusion
ORR
Proportion of subjects with the best overall response (BOR) of subjects with PR (partial response) and CR (complete response) as determined by local investigator using RECIST 1.1
Time frame: Up to 52 weeks
DCR
Disease control rate: The proportion of subjects with CR (complete response), PR (partial response) or SD (stable disease lasting over 6 months) as determined by local investigator using RECIST 1.1.
Time frame: Up to 52 weeks
DOR
Duration of response: The duration of time from record of response to first progression of disease as determined by RECIST 1.1 or death date not relevant to disease progression.
Time frame: Up to 52 weeks
PFS
Progression free survival: The time of disease progression by RECIST 1.1 or death since cell infusion.
Time frame: Up to 52 weeks
TEAE
Number, severity and duration of treatment of emergent adverse events (TEAEs) that occur during treatment according to NCI-CTCAE v 5.0.
Time frame: Up to 52 weeks
PK
The % of patients with detectable CCT301-38 cells in peripheral blood. \[Time Frame: Up to 52 weeks\]
Time frame: Up to 52 weeks
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Biomarker
To evaluate the correlation of AXL biopsy score to ORR. \[Time Frame: Up to 52 weeks\]
Time frame: Up to 52 weeks