Phase 2 Study of CD30.CAR-T Cell Therapy for Patients with Relapsed or Hard-to-Treat Hodgkin Lymphoma

Sponsor: Tessa Therapeutics

Sponsor score: 0

ClinicalTrials ID:NCT04268706

Provider View

This clinical trial is testing a new treatment using CD30.CAR-T cells for adults and children with Hodgkin Lymphoma that has returned or not responded to previous treatments. The study aims to evaluate the safety and effectiveness of this therapy.

Patient Parameters

Program Overview

This study is designed to test the safety and effectiveness of a new treatment called CD30.CAR-T cell therapy in patients with Hodgkin Lymphoma that has come back or not responded to other treatments. The trial is open to both adults and children and involves two parts: an initial phase to check safety and a second phase to further evaluate how well the treatment works. Participants will have their blood collected to create the CD30.CAR-T cells, receive chemotherapy to prepare their body, and then get the CD30.CAR-T cells through an IV infusion. They will be closely monitored for safety and effectiveness throughout the study, which lasts up to 24 months, with additional follow-up afterward.

Description

In this study, participants will receive a new treatment called CD30.CAR-T cell therapy, which uses their own modified immune cells to target and attack cancer cells. The study has two parts: the first part focuses on safety, and the second part looks at how well the treatment works. Participants will have their blood drawn to create the CD30.CAR-T cells. While waiting for these cells to be ready, they may receive chemotherapy to help control the cancer. Before receiving the CD30.CAR-T cells, participants will undergo a short course of chemotherapy to prepare their body. The CD30.CAR-T cells are then given as a single infusion. Depending on their response, participants may receive a second infusion. Throughout the study, participants will be monitored for side effects and how well the treatment is working. They will also complete quality of life assessments. After the main study period, participants will continue to be followed for long-term effects and survival.

Eligibility Criteria

Inclusion Criteria

  • Signed informed consent form.
  • Aged between 12 and 75 years.
  • Diagnosed with classical Hodgkin Lymphoma.
  • Cancer has returned or not responded after at least three previous treatments, including chemotherapy, BV, or PD-1 inhibitors.
  • Tumor tests positive for CD30.
  • At least one tumor that can be measured by scans.
  • Meet specific blood and organ function criteria, including:
    • Hemoglobin level of at least 8.0 g/dL.
    • Total bilirubin level no more than 1.5 times the normal limit.
    • AST and ALT levels no more than 5 times the normal limit.
    • Creatinine clearance greater than 45 mL/min.
    • Neutrophil count greater than 1,000/µL.
    • Platelet count greater than 75,000/µL.
    • Normal blood clotting times.
  • Good overall health with a performance status score of 0 or 1.
  • Expected to live for more than 12 weeks.

Exclusion Criteria

  • Cancer has spread to the brain or spinal cord.
  • Active or serious brain-related conditions like seizures or stroke.
  • Uncontrolled bleeding or bleeding disorders.
  • Poor lung function with low oxygen levels.
  • Heart function below 45%.
  • Currently taking immunosuppressive drugs or steroids.
  • Recent treatments with anti-CD30 therapies or investigational drugs.
  • Recent stem cell transplants.
  • Active graft versus host disease.
  • HIV infection.
  • Active hepatitis B or C infections.
  • Unresolved severe side effects from previous treatments.
  • Allergic reactions to certain proteins or ingredients in the treatment.
  • Severe heart disease.
  • Another active cancer or history of cancer in the last 3 years.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • Any other serious or unstable medical conditions.

Locations

FACILITYZIPCITYSTATE
City of Hope Comprehensive Cancer Center91010DuarteCalifornia
University of Chicago Medical Center60637ChicagoIllinois
Children's Hospital of Philadelphia19104PhiladelphiaPennsylvania
Sarah Cannon Research Institute37203NashvilleTennessee
MD Anderson Cancer Center77030HoustonTexas

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