Study on DOC1021 Dendritic Cell Immunotherapy for Hard-to-Treat Melanoma

Sponsor: Diakonos Oncology Corporation

Sponsor score: 0

ClinicalTrials ID:NCT07288112

Provider View

This clinical trial is testing a new treatment called DOC1021, which uses a patient's own immune cells to fight melanoma that hasn't responded to other treatments. The study aims to see if this approach is safe and can help shrink tumors.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new treatment called DOC1021, combined with a drug called pIFN, is safe and can help reduce tumors in patients with melanoma that hasn't responded to other treatments. DOC1021 is a type of immunotherapy made from a patient's own blood cells, which are modified to target the cancer. The study has two parts: the first part checks the safety of the treatment, and the second part looks at how well it works.

Description

Participants in this study will undergo several procedures:

  • They will take a medication called filgrastim for five doses and then have a procedure called leukapheresis to collect white blood cells.
  • They will receive two doses of the DOC1021 treatment, guided by imaging, two weeks apart.
  • They will also receive weekly injections of pIFN for four weeks, alongside the DOC1021 treatment.
  • An optional booster injection of DOC1021 may be given about six months after the first dose, along with additional pIFN injections.
  • Participants will visit the clinic regularly to check their quality of life, symptoms, medication use, and undergo imaging and blood tests. They may also receive optional treatment with anti-PD1 agents.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed consent and agree to follow study procedures.
  • Must be 18 years or older.
  • Have melanoma that cannot be removed by surgery or has spread, and has not responded to at least one previous treatment, including anti-PD-1 therapy.
  • Must be willing to stop anti-PD-1 treatment for about six weeks after starting DOC1021.
  • Must have one or more tumors available for biopsy and at least one measurable tumor after DOC1021 treatment.
  • Stable brain metastases are allowed if previously treated.
  • Must be able to receive filgrastim, leukapheresis, and DOC1021 injections.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study.
  • Must have adequate kidney, liver, bone marrow, and immune function, as shown by specific blood tests.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Active HIV or hepatitis infection, unless well-controlled.
  • Severe or uncontrolled medical conditions that could affect participation, including certain heart diseases and autoimmune disorders requiring immunosuppression.
  • Residual severe side effects from previous immunotherapy, except well-controlled endocrine issues.
  • Participation in another experimental treatment within the last 30 days.

Locations

FACILITYZIPCITYSTATE
The University of Alabama at Birmingham35233BirminghamAlabama
City of Hope91010DuarteCalifornia

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