Study on ST-067 and CAR T-Cell Therapy for Treating Relapsed or Hard-to-Treat Large B-Cell Lymphoma

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT07098364

Provider View

This clinical trial is testing a new treatment combining ST-067 with CAR T-cell therapy (liso-cel) to see if it is safe and effective for patients with large B-cell lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment that combines ST-067, a modified human protein that may help the immune system fight cancer, with CAR T-cell therapy (liso-cel), which uses a patient's own immune cells to target cancer. This treatment is for patients with large B-cell lymphoma (LBCL) that has either come back after treatment or has not responded to previous therapies.

Description

This study is divided into two phases: Phase I focuses on finding the safest dose of ST-067, and Phase II evaluates how well the treatment works.

Participants will undergo a process called leukapheresis to collect immune cells, followed by chemotherapy to prepare the body. They will receive the CAR T-cell therapy (liso-cel) through an IV on day 0. ST-067 will be given as a shot under the skin on specific days. The treatment can continue for up to 8 doses unless the disease progresses or side effects become too severe.

Throughout the study, participants will have various tests, including imaging scans and blood tests, to monitor their health and the treatment's effects. After completing the treatment, follow-up visits will occur at 3, 6, 9, and 12 months, and then as needed for long-term monitoring.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Diagnosed with large B-cell lymphoma (LBCL) that has returned or not responded to at least two previous treatments.
  • Cancer must show activity on PET scans or have evidence of active disease.
  • Cancer cells must have the CD19 marker.
  • Must be in relatively good health with a performance status of 60% or higher.
  • Adequate blood cell counts and organ function.
  • Women of childbearing potential must use contraception for at least 30 days after the last dose of ST-067.
  • Men must use effective contraception for at least 90 days after the last dose of ST-067.
  • Must understand and agree to the study procedures and provide informed consent.

Exclusion Criteria

  • Use of an out-of-specification liso-cel product.
  • History of another cancer, except for certain treated skin cancers or cancers in remission for at least 2 years.
  • Use of high-dose steroids or other immunosuppressive drugs shortly before treatment.
  • Previous treatment with CD19 CAR T-cell therapy.
  • Active hepatitis B or C, or HIV infection.
  • Pregnant or breastfeeding women.
  • Previous treatment with IL-1 or IL-18 agents.
  • Active autoimmune or inflammatory disorders requiring treatment.
  • Recent significant heart problems or severe heart disease.
  • Serious central nervous system conditions like epilepsy or stroke.
  • History of organ transplantation.
  • Active, serious infections.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

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