Study on CD30biAb-AATC for Treating CD30+ Cancers

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05544968

Provider View

This clinical trial is testing a new immunotherapy treatment that uses a patient's own T-cells to target and attack cancer cells with a specific marker called CD30. The study aims to determine if this approach is safe and effective for adults with certain types of cancer that have returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment for cancers that have a marker called CD30. The treatment involves using a patient's own T-cells, which are modified in the lab to recognize and attack cancer cells. The main goals are to assess the safety and effectiveness of this treatment in adults with CD30+ cancers that have come back or not responded to other treatments. Participants will have their T-cells collected and may receive chemotherapy while the treatment is being prepared. They will then receive the modified T-cells through infusions, along with a medication to support the immune system, over a period of up to two cycles.

Description

This is a Phase I study, meaning it is an early stage trial to test the safety and feasibility of a new treatment called CD30 biAb-AATC for adults with CD30+ cancers that have returned or not responded to previous treatments. Participants will have their T-cells collected and may receive a short course of chemotherapy while the treatment is being prepared. Once ready, the modified T-cells will be given through infusions, with doses gradually increasing to find the safest and most effective amount. Participants will also receive a medication called GM-CSF to help support their immune system. The treatment is given in cycles, with each cycle lasting four weeks, and participants can receive up to two cycles in total.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of a cancer with the CD30 marker, either at the original diagnosis or at relapse.
  • For lymphomas, must have measurable disease with tumors of a certain size.
  • For leukemias, must have disease that has returned or not responded to treatment.
  • Must have recovered from any side effects of previous cancer treatments.
  • Must be 18 years or older.
  • Must have a life expectancy of more than 12 weeks.
  • Must have a performance status that allows for daily activities, even if using a wheelchair.
  • Must have acceptable organ function based on medical tests.
  • Women must not be pregnant, and both men and women must agree to use effective birth control during and after the study.
  • Must be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Must not have severe side effects from previous treatments.
  • Must not have received any experimental treatments within 14 days before joining the study.
  • Must not have immune system disorders or be on certain immune-suppressing medications.
  • Must not have uncontrolled infections.
  • Must not have a history of lung problems related to CD30 treatments.
  • Must not have certain heart conditions or uncontrolled high blood pressure.
  • Must not have allergies to the study treatment or similar products.
  • Must not be pregnant or breastfeeding, and women with infants must agree not to breastfeed during the study.
  • Must not have had another cancer in the past year, except for certain skin cancers or in situ cancers.

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