Dendritic cell therapy combined with chemotherapy for pancreatic cancer

Phase I Study of Th-1 Dendritic Cell Immunotherapy in Combination With Standard Chemotherapy for the Adjuvant Treatment of Pancreatic Adenocarcinoma (DECIST)

This study is testing a new treatment that combines a special type of immune cell therapy with chemotherapy to see if it helps people with pancreatic cancer after surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Diakonos Oncology Corporation (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation, methotrexate, prednisone
• Locations: 3 sites (Houston, Texas and 2 other locations)
• Trial ID: NCT04157127 on ClinicalTrials.gov

What this trial studies

This phase 1 trial evaluates the safety and feasibility of using autologous dendritic cell therapy in patients with pancreatic adenocarcinoma following surgical resection. Patients will undergo apheresis to manufacture dendritic cells loaded with cancer lysate and mRNA, which will then be administered via image-guided injections near the surgical site. The study aims to assess the toxicity and effectiveness of this immunotherapy approach in conjunction with standard chemotherapy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with resectable or borderline resectable pancreatic adenocarcinoma or adenosquamous carcinoma.

Not a fit: Patients with advanced or unresectable pancreatic cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance the immune response against pancreatic cancer, potentially improving patient outcomes.

How similar studies have performed: While this approach is novel, other studies have shown promise in using immunotherapy for pancreatic cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria

An individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Male or female, aged 18 years and older
3. Cytological or pathological confirmation of adenocarcinoma or adenosquamous carcinoma of the pancreas is deemed to be potentially resectable or borderline resectable based on tumor and host factors. This may include patients who undergo upfront resection or those who receive neoadjuvant chemotherapy +/- radiation prior to resection.
4. Adequate kidney, liver, bone marrow function, and immune function, as follows, within 28 days prior to registration:

   1. Hemoglobin ≥ 8.0 gm/dL
   2. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
   3. Platelet count ≥ 75,000 /mm3
   4. Total bilirubin ≤ 1.5 times upper limit of normal (ULN),
   5. Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 2.5 times the ULN
5. ECOG performance status ≤ 2.
6. For women of childbearing potential (WOCBP): use of highly effective contraception must be discussed with participants. NOTE: Patient must agree to start contraception at least 30 days before first vaccination and continue for at least 12 weeks after her last vaccination.
7. WOCBP must have a negative serum pregnancy prior to vaccination
8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 12 weeks following discontinuations of last vaccination.
9. Patient must agree to not donate blood for up to 90 days after last vaccination.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Unresectable or metastatic (stage IV) pancreatic cancer.
2. Patients with known HIV and a positive viral load.
3. Patients with active HBV and HCV infection. Those who are Hepatitis B sAb positive as well as those who are Hepatitis C Ab positive, but Hepatitis C RNA viral load negative will not be excluded.
4. Patients with any active autoimmune disease or immune deficiency or previous Guillain-Barre syndrome. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g. patient with psoriatic arthritis are excluded) are eligible provided all of the following conditions are met:

   1. Rash that covers less than 10 % of body surface area.
   2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
   3. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
5. Use of nonstandard neoadjuvant chemotherapy regimen, as determined by the Investigator.
6. Female patients who are pregnant, breastfeeding, or of childbearing potential without a negative pregnancy test within 28 days (or decline contraception requirements as outlined above). Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
7. Patients unwilling or unable to comply with the protocol or provide informed consent.
8. Any severe or uncontrolled medical condition or other condition that could affect participation in this study (in the opinion of the investigator), including but not limited to hyper/hypothyroidism, active systemic autoimmune disorders, untreated viral hepatitis or autoimmune hepatitis.
9. Requires chronic treatment with a systemic steroid (⩾10 mg/day of prednisone equivalent) or with any systemic immunosuppressive agent.

Where this trial is running

Houston, Texas and 2 other locations

• Baylor College of Medicine Medical Center - McNair Campus — Houston, Texas, United States (Recruiting)
• Baylor St. Lukes Medical Center — Houston, Texas, United States (Recruiting)
• Dan L. Duncan Cancer Center at Baylor College of Medicine — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Benjamin Musher, MD — Baylor College of Medicine
• Study coordinator: Benjamin Musher, MD

Conditions Pancreatic Adenocarcinoma; Pancreatic Cancer; Pancreatic Adenosquamous Carcinoma; Immunotherapy; Adjuvant therapy; Cell Therapy