Study on KSQ-004EX, a New Treatment Using Modified Immune Cells for Advanced Solid Tumors

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06598371

Provider View

This clinical trial is testing a new treatment called KSQ-004EX, which uses a patient's own immune cells that are modified in the lab to target and fight advanced solid tumors. The study aims to find the best dose and see if this treatment is safe and effective in controlling these cancers.

Patient Parameters

Program Overview

The study is divided into two phases. Phase 1 aims to find the best dose of KSQ-004EX for patients with advanced solid tumors, such as melanoma, lung, head and neck, colorectal, pancreatic, and cervical cancers. Phase 2 will test if this dose can help control these cancers. Both phases will also look at the safety and effects of KSQ-004EX.

Description

In Phase 1, the main goal is to see if KSQ-004EX is safe and well-tolerated in adults with advanced solid tumors. Researchers will also determine the best dose to use in future studies and check if the treatment shows any early signs of effectiveness against tumors. They will also evaluate how feasible it is to produce this treatment.

In Phase 2, the focus is on assessing how well KSQ-004EX works in shrinking tumors in patients with advanced cancers. The study will continue to monitor the safety and tolerability of the treatment, as well as its impact on patients' overall survival. Researchers will also explore the manufacturing process to ensure it can be consistently produced.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced or metastatic melanoma, lung, head and neck, colorectal, pancreatic, or cervical cancer that has not responded to previous treatments.
  • Have a tumor that can be used to create the KSQ-004EX treatment.
  • Have at least one tumor that can be measured to track the treatment's effect.
  • Be 18 years or older.
  • Have a life expectancy of at least 12 weeks.
  • Have recovered from previous cancer treatments, except for certain side effects like hair loss or nerve damage.
  • Be in good overall health, with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Have a washout period from previous cancer treatments before starting the study treatment.
  • Women of childbearing potential must use effective contraception during the study and for three months after. Men must use barrier contraception during the study and for three months after.
  • Be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Have had an organ transplant or previous cell therapy with certain chemotherapy regimens.
  • Have allergies to any components of the KSQ-004EX treatment or related medications.
  • Have active autoimmune or inflammatory disorders, except for certain conditions like vitiligo or controlled hypothyroidism.
  • Have active infections requiring IV antibiotics.
  • Have certain types of melanoma or lung cancer with specific characteristics.
  • Have untreated or symptomatic brain metastases.
  • Have ascites (fluid buildup in the abdomen).
  • Be pregnant or nursing.
  • Have certain viral infections like HIV, hepatitis B, or hepatitis C, unless controlled.
  • Have a history of severe heart or lung conditions.
  • Have received a live vaccine within 28 days before starting the study treatment.
  • Have other active cancers requiring treatment, except for certain skin cancers.
  • Have any medical or psychiatric conditions that would interfere with the study.

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Center77030HoustonTexas

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