Phase 2 Study of CD70.CAR NK Cells for Treating Difficult or Returning Lymphomas

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07164469

Provider View

This clinical trial is exploring a new treatment using CD70.CAR NK cells to help control lymphomas that are hard to treat or have returned after initial treatment. The study focuses on patients with Diffuse Large B-Cell Lymphoma (DLBCL) and Hodgkin Lymphoma (HL).

Patient Parameters

Program Overview

The main goal of this study is to see if CD70.CAR NK cell therapy can effectively treat patients with lymphomas that are either difficult to treat from the start or have come back soon after initial treatment. Researchers will measure success by looking at how many patients remain free of cancer events for two years. They will also study how well the treatment works, its safety, and how long the modified cells stay in the body.

Description

This study is testing a new therapy using CD70.CAR NK cells, which are specially modified cells designed to target and attack cancer cells in patients with certain types of lymphoma. The primary aim is to see if this treatment can help patients stay free of cancer events for two years. Researchers will also look at how well the treatment works overall, its safety, and how long the modified cells remain in the body. Additionally, they will conduct detailed studies to understand how the body responds to the treatment and what factors might affect its success.

Eligibility Criteria

Inclusion Criteria

  • Aged between 18 and 75 years.
  • Diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL) or Hodgkin Lymphoma (HL) that is either:
    • Hard to treat from the start or has returned within 3 months after initial treatment.
    • Returned within 12 months after initial treatment.
  • Tumor tests positive for CD70 marker.
  • Have at least one measurable tumor on a PET/CT scan.
  • In good general health with an ECOG performance status of 0 to 2.
  • Adequate blood counts and organ function.
  • Not pregnant or breastfeeding, and willing to use effective birth control.
  • No active hepatitis B or C infections, or infections are well-controlled.
  • Treated brain metastases are allowed if stable.
  • No other active cancers that interfere with the study.
  • Willing to sign informed consent and follow study procedures.

Exclusion Criteria

  • No measurable disease or cancer in complete remission.
  • Recent major surgery within 4 weeks before starting the study.
  • Any severe or uncontrolled medical conditions.
  • Active cancer other than the ones being studied, except for certain skin or cervical cancers.
  • Severe side effects from previous treatments that haven't improved.
  • Active hepatitis B or C infections.
  • Active infections requiring IV antibiotics.
  • HIV infection.
  • Recent treatment with other cancer drugs within 2 weeks.
  • Active brain involvement by cancer.
  • Life expectancy of 6 months or less.
  • Uncontrolled neurological disorders.
  • Currently on systemic steroids or certain immune therapies.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.