The goal of this clinical trial is to assess safety and tolerability of escalating doses of MT-601 administered during the off week of chemotherapy regimen for patients with pancreatic cancer. The main question\[s\] it aims to answer are: safety and efficacy • overall response rate and duration of response. Participants will meet all applicable inclusion criteria prior to chemotherapy and must agree to provide apheresis material.
The Dose Escalation portion of the study will use a modified 3+3 design to define an acceptable dose of MT-601 in combination with maintenance capecitabine following completion of FFX or NLX chemotherapy. For the Dose Expansion, MT-601 will be administered at the dose determined to be safe based on the results from the Dose Escalation portion. Front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) will be administered as per standard of care. MT-601 will be administered intravenously over no less than 5 minutes as a single dose following completion of all planned doses of FFX or NLX chemotherapy and after participants have started receiving maintenance capecitabine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
MT-601 Dose 200 million cells
MT-601 Dose 400 million cells
MT-601 Dose 800 million cells
MT-601 Dose 1200 million cells
The University of Texas MD Anderson
Houston, Texas, United States
During Dose Escalation - determine the MTD, recommended expansion dose, or MPD of MT-601 administered during maintenance capacitabine following treatment with FOLFIRINOX (FFX) or NALIRIFOX (NLX).
Dose-limiting toxicities (DLTs)
Time frame: Through study completion. Approximately 24 months
During Dose Expansion - evaluate the safety profile of MT-601
To evaluate the safety profile of MT-601 administered during maintenance capecitabine following treatment with FFX or NLX -Safety (including but not limited to): TEAEs, SAEs, and deaths
Time frame: Through study completion. Approximately 2.5 years
During Dose Escalation and Dose Expansion - determine the Efficacy of MT-601
Evaluate the efficacy of MT-601 administered during maintenance capecitabine following treatment with FFX or NLX with the endpoints of Progression Free Survival (PFS) and Duration of Response (DOR).
Time frame: Through study completion. Approximately 2.5 years
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