Status:
NOT_YET_RECRUITING
MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Lead Sponsor:
Marker Therapeutics, Inc.
Conditions:
Pancreas Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 mai...
Detailed Description
The Dose Escalation portions will proceed using a standard 3+3 design. Flat doses of MT-601 will be administered ranging from 200 million cells to 400 million cells. For the Dose Expansion, MT-601 wil...
Eligibility Criteria
Inclusion
- Cytologically or histologically confirmed newly diagnosed locally advanced, unresectable or metastatic pancreatic adenocarcinoma (excluding other pancreatic malignancies such as acinar cell carcinomas or neuroendocrine cell neoplasms, etc.).
- Eligible for reassessment following 2 months of front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel): Patient must have experienced a response of SD, PR, or CR per RECIST v1.1 after 2 months of front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel).
- ≥18 years of age prior to administration of MT-601.
- Measurable or evaluable disease per RECIST v1.1 at the time of screening.
- Must have sufficient leukapheresis material to manufacture autologous MT601.
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Life expectancy ≥12 weeks.
- Pulse oximetry of \>90% on room air in patients with previous radiation therapy.
- Adequate organ function, as defined below:
- Absolute neutrophil count (ANC) ≥1.5 × 109/L
- Platelets ≥75 × 109/L
- Hemoglobin ≥9 g/dL (can be transfused)
- International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × upper limit of normal (ULN) (unless patient receiving stable dose of anticoagulant therapy as long as PT or INR in therapeutic range of intended anticoagulant)
- Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) PTT or aPTT ≤ 5 seconds above ULN (unless patient receiving stable dose of anticoagulant therapy "a" as long as PT or INR in therapeutic range of intended anticoagulant)
- Total bilirubin ≤2 × ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN OR ≤5 × ULN if liver has tumor involvement
- Serum creatinine OR calculated (as per institutional standards) creatinine clearance ≤2 × ULN OR measured or calculated ≥50 mL/min for patients "a" If receiving anticoagulation, the patient must have no active bleeding within 14 days prior to baseline assessment.
- Sexually active patients must be willing to utilize one of the highly effective birth control methods or practice complete abstinence between initiation of screening for MT-601 infusion and 6 months after the last MT-601 infusion. Male patients who are sexually active must agree to use a condom during this period.
- Disease imaging prior to administration of front-line chemotherapy and reimaging prior to administration of MT-601.
Exclusion
- N/A
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06549751
Start Date
September 1 2024
End Date
December 1 2027
Last Update
August 12 2024
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