ST-067 + CAR T-cell Therapy for Large B-Cell Lymphoma

Overseen By Immunotherapy Intake Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Fred Hutchinson Cancer Center

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: HIV, Hepatitis B/C, Autoimmune disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I/II trial tests the safety, side effects, and best dose/regimen of ST-067 in combination with CD19-directed chimeric antigen receptor (CAR) T-cell therapy (liso-cel) and how well it works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (recurrent) or LBCL that has not responded to previous treatment (refractory). ST-067 is an engineered variant of the human cytokine interleukin-18 that may help the immune system kill cancer cells. Lisocabtagene maraleucel (liso-cel) is an autologous CAR T-cell therapy prepared using the person's own immune system (a group of cells, tissues, and organs that protect the body from attack by bacteria, viruses, and cancer cells) to fight the cancer. Giving ST-067 in combination with liso-cel may better treat patients with relapsed/refractory LBCL.

Who Is on the Research Team?

Alexandre V. Hirayama, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for patients with large B-cell lymphoma that has either returned after treatment or hasn't responded to previous therapies. Participants must meet specific health criteria, which are not detailed here.

Inclusion Criteria

I am 18 years old or older.

I have LBCL and have undergone at least 2 treatments, qualifying for liso-cel therapy.

I can care for myself but cannot do normal activities or work.

Exclusion Criteria

Planned use of out-of-specification liso-cel product

I have had cancer before, but it's one of the exceptions.

I am planning to take high doses of steroids or other drugs that weaken my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Leukapheresis and Lymphodepleting Chemotherapy

Patients undergo leukapheresis and lymphodepleting chemotherapy between days -5 to -3 prior to treatment

1 week

1 visit (in-person)

Treatment

Patients receive liso-cel IV on day 0 and ST-067 SC weekly on specified days. Treatment continues for up to 8 doses.

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment at 3, 6, 9, and 12 months after CAR T-cell infusion

12 months

4 visits (in-person)

Long-term Follow-up

Patients will be followed per standard of care long-term follow-up until the patient dies, is lost to follow-up, or withdraws consent

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Lisocabtagene Maraleucel
• ST-067

Trial Overview The trial is testing ST-067 combined with a CAR T-cell therapy called liso-cel. It's in phases I/II to determine safety, side effects, and the best dose for treating relapsed/refractory large B-cell lymphoma.

How Is the Trial Designed?

Group I: Treatment (liso-cel, ST-067) Experimental Treatment 13 Interventions

Patients undergo leukapheresis and lymphodepleting chemotherapy between days -5 to -3 prior to treatment and receive liso-cel IV on day 0. Patients then receive ST-067 SC weekly on days 14, 21, and 28 or days 10, 17, and 24. Patients may continue to receive maintenance ST-067 SC at day 35 once weekly. Treatment continues for up to 8 doses in the absence of disease progression or unacceptable toxicity. Patients undergo x-ray imaging, and ECHO or MUGA during screening. Patients also undergo CT and/or PET as well as lumbar puncture for CSF collection and bone marrow aspiration and biopsy as clinically indicated during screening and follow-up. Patients undergo blood sample collection throughout the study.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Simcha Therapeutics

Collaborator

Trials

2

Recruited

40+