Study on the Safety and Tolerability of CFT7455 for Patients with Relapsed or Hard-to-Treat Non-Hodgkin's Lymphoma or Multiple Myeloma

Sponsor: C4 Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04756726

This clinical trial is testing a new oral medication, CFT7455, to see if it is safe and well-tolerated in patients with Non-Hodgkin's Lymphoma or Multiple Myeloma that has returned or is not responding to treatment. The study will also explore how the drug behaves in the body and its effects on tumors.

Patient Parameters

Program Overview

The aim of this study is to evaluate the safety and effects of a new oral drug called CFT7455 in patients with Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM) that has come back or is not responding to previous treatments. The study will test different doses of CFT7455, which may be given alone or with another drug, dexamethasone, for MM patients. Researchers will monitor how the drug is processed in the body and its impact on cancer.

Eligibility Criteria

Inclusion Criteria

  • Be willing and able to provide signed consent to participate.
  • Be 18 years or older.
  • Have a performance status score of 2 or less, indicating the ability to carry out daily activities with some limitations.
  • Have a confirmed diagnosis of NHL or MM that has returned or is not responding to previous treatments, and not be eligible for other beneficial treatments or have refused them.
  • For MM patients:
    • Have measurable disease at the start of the study.
    • Have received at least 3 prior treatments, including specific drugs like lenalidomide and a proteasome inhibitor.
    • Have disease that is resistant to or has progressed shortly after the last treatment.
  • For NHL patients:
    • Have a documented diagnosis and measurable disease.
    • Have received specific prior therapies depending on the type of NHL.
  • Provide a tumor tissue sample for analysis.
  • Have adequate organ function based on specific blood tests.
  • Women must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.
  • Men must use a condom during intercourse with women of childbearing potential and refrain from donating sperm during and after treatment.
  • Refrain from donating blood during and after treatment.

Exclusion Criteria

  • Have disease affecting the central nervous system.
  • Have received radiation therapy within 2 weeks before starting the study.
  • Have active lung inflammation (pneumonitis).
  • Have certain types of blood cancers or conditions like plasma cell leukemia or amyloidosis.
  • Have received a specific drug, CC92480, in the most recent treatment.
  • Have significant nerve damage or heart problems.
  • Have had a blood clot within 3 months before starting the study.
  • Have another cancer that has progressed or required treatment in the past 3 years.
  • Have had major surgery within 2 weeks before starting the study.
  • Have significant side effects from previous cancer treatments.
  • Have received a live vaccine within 4 weeks before starting the study.
  • Have a history of HIV or active hepatitis B or C infections.
  • Have an uncontrolled infection or serious medical condition.
  • Be taking certain medications that affect how the study drug works.
  • Be participating in another clinical trial or have used an investigational treatment recently.
  • Have difficulty swallowing pills or have a condition affecting digestion.
  • Have a psychiatric or substance abuse disorder that would interfere with the study.
  • Have an allergy to the study drug or its ingredients.

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