This is a single-arm, open label, dose escalation, phase I study of C-CAR039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma.
This is a single-arm, open label, "3+3" dose escalation, phase I study to evaluate the safety and preliminary efficacy of C-CAR039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma. 10 patients are planned to be enrolled. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of C-CAR039. Following manufacture of the drug product, subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to C-CAR039 infusion. All subjects who have received C-CAR039 infusion will be followed for up to 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
MTD
maximum tolerated dose or clinical recommended dose
Time frame: Up to 24 months after C-CAR039 infusion
DLT
Dose limiting toxicity
Time frame: Up to 28 days after C-CAR039 infusion
AE/SAE/AESI
adverse events (AE), serious adverse event (SAE), adverse events of sepical interest (AESI) (including cytokine release syndrome (CRS), and nerve toxicity), laboratory tests (type, frequency and severity), vital signs and ECG abnormality rate.
Time frame: Up to 24 months after C-CAR039 infusion
C-CAR039 CAR expansion and persistence
After C-CAR039 infusion, peripheral blood EXP039 CAR expansion and persistence in vivo, including Cmax, Tmax, AUC0-28day, Tlast
Time frame: Up to 24 Months after C-CAR039 infusion
Overall response rate (ORR)
Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria
Time frame: Up to 24 Months after C-CAR039 infusion
Duration of response (DOR)
The time from the date of first response (PR or better) to the date of disease progression or death after C-CAR039 infusion
Time frame: Up to 24 Months after C-CAR039 infusion
Progression-free survival (PFS)
The time from C-CAR039 infusion to the date of progression as assessed by Lugano 2014 criteria or death
Time frame: Up to 24 Months after C-CAR039 infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Overall survival (OS)
The time from C-CAR039 infusion to the date of death
Time frame: Up to 24 Months after C-CAR039 infusion