Study on ONC-PluReceptor NK Cells with Epcoritamab and Tafasitamab for Patients with Recurrent or Hard-to-Treat B-cell Non-Hodgkin Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07283679

Provider View

This clinical trial is exploring a new treatment using ONC-PluReceptor NK cell therapy combined with the drugs epcoritamab and tafasitamab to see if it can help control B-cell Non-Hodgkin Lymphoma that has returned or is not responding to other treatments. The study will also assess the safety of this treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if a new treatment using ONC-PluReceptor NK cells, along with the drugs epcoritamab and tafasitamab, can effectively manage B-cell Non-Hodgkin Lymphoma that has come back or is resistant to previous treatments. Researchers will also study how safe this treatment is for patients.

Description

The main goal of this study is to determine the safe dose of ONC-PluReceptor NK cells, which are derived from umbilical cord blood and modified to target cancer cells, when used with epcoritamab and tafasitamab in patients with difficult-to-treat B-cell Non-Hodgkin Lymphoma.

Secondary goals include:

  • Measuring how well patients respond to the treatment, including complete and partial responses.
  • Determining how long the response lasts.
  • Evaluating how long patients live without the disease getting worse.
  • Assessing overall survival time.
  • Tracking how long the infused NK cells remain in the body.
  • Conducting detailed studies on the immune system's recovery.

Eligibility Criteria

Inclusion Criteria

  • Have B-cell Non-Hodgkin Lymphoma that has returned or not responded to at least two previous treatments, or after a stem cell transplant.
  • Have previously tried CAR-T therapy or are not eligible for it.
  • Tumor tests positive for CD19 or CD20 markers.
  • Aged between 18 and 80 years.
  • Have a performance status score of 60% or higher, indicating the ability to carry out daily activities.
  • Have certain blood cell counts and organ functions within specified limits.
  • Women of childbearing potential must not be pregnant or breastfeeding and must use effective birth control during and after the study.
  • Men must also agree to use effective contraception during and after the study.
  • Agree to participate in long-term follow-up for regulatory purposes.

Exclusion Criteria

  • Lymphoma in complete remission with no measurable disease.
  • Major surgery within four weeks before starting the study treatment.
  • Any severe or uncontrolled medical condition that could increase risks.
  • Any other active cancer, except for certain treated skin or cervical cancers.
  • Severe side effects from previous treatments that have not improved.
  • Active hepatitis B or C infections.
  • Active infections requiring intravenous antibiotics.
  • HIV infection.
  • Recent treatment with any anti-cancer drugs within two weeks.
  • Active cancer spread to the brain or spinal fluid.
  • Life expectancy of six months or less.
  • Uncontrolled neurological disorders.
  • Use of systemic steroids or certain immune therapies close to the time of enrollment.

Locations

FACILITYZIPCITYSTATE
The University of Texas M. D. Anderson Cancer Center77030HoustonTexas

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