Clinical trial NCT06549751: MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Official title: A Phase 1 Study Of Patient-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-601) Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Pancreas Cancer
Lead sponsor: Marker Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 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.

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 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 10 minutes (± 5 minutes) during the "off" week of front-line chemotherapy. Patients will receive up to 6 infusions of MT-601 approximately every 4 weeks.

Eligibility criteria: Inclusion Criteria:

1. 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.).
2. 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).
3. ≥18 years of age prior to administration of MT-601.
4. Measurable or evaluable disease per RECIST v1.1 at the time of screening.
5. Must have sufficient leukapheresis material to manufacture autologous MT601.
6. Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
7. Life expectancy ≥12 weeks.
8. Pulse oximetry of \>90% on room air in patients with previous radiation therapy.
9. 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.
10. 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.
11. Disease imaging prior to administration of front-line chemotherapy and reimaging prior to administration of MT-601.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: During Dose Escalation - assess the safety and tolerability of escalating doses of MT-601 administered during the off week of chemotherapy regimen.
timeFrame: Through study completion. Approximately 3 years
measure: During Dose Expansion - estimate overall response rate (ORR) of MT-601
timeFrame: Through study completion. Approximately 3 years
measure: During Dose Expansion - estimate duration of response (DOR) of MT-601
timeFrame: Through study completion. Approximately 3 years
Secondary outcomes:
measure: During Dose Escalation and Dose Expansion - determine the Efficacy of MT-601
timeFrame: Through study completion. Approximately 3 years
measure: During Dose Expansion - assess safety and tolerability of MT-601
timeFrame: Through study completion. Approximately 3 years
Other outcomes:
measure: Exploratory: During Dose Escalation and Dose Expansion - examine the expansion, persistence, clonality and anti-tumor immune effects of the adoptively transferred, autologous MT-601, as well as the presence of epitope spreading in all groups
timeFrame: Through study completion. Approximately 3 years
measure: Exploratory: During Dose Escalation and Dose Expansion - assess anti-tumor activity of MT-601 administered during the off week of chemotherapy regimen based on iRECIST
timeFrame: Through study completion. Approximately 3 years
Locations:
Study officials:
affiliation: Marker Therapeutics
name: Patricia Allison, BS
role: STUDY_DIRECTOR
References: