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 trial explores the combination of two treatments, ST-067 and CAR T-cell therapy (liso-cel), to determine their effectiveness in treating large B-cell lymphoma (LBCL) that has returned or not responded to previous treatments. ST-067 is a modified protein that may enhance the immune system's ability to combat cancer cells. Liso-cel (lisocabtagene maraleucel) is a therapy derived from a person's own immune cells, designed to target cancer. Individuals with LBCL who have tried at least two different treatments without success might be suitable candidates for this trial. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot use therapeutic doses of corticosteroids or other systemic immunosuppressants shortly before certain trial procedures. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lisocabtagene maraleucel, or liso-cel, is generally safe. A study that followed participants for three years found no new safety concerns. Common side effects included some immune reactions, such as cytokine release syndrome, which were usually manageable.

Researchers are testing ST-067 with liso-cel to determine the safest way to use it. This early-stage trial examines how well people can tolerate the treatment. Since it remains in the early testing phase, detailed safety information is not yet available.

In summary, liso-cel has a known safety record, while ST-067 is still under study for its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Lisocabtagene Maraleucel (liso-cel) combined with ST-067 for treating Large B-Cell Lymphoma because this approach offers a new way to tackle the disease. Liso-cel is a type of CAR T-cell therapy, which is engineered to target and destroy cancer cells more effectively than traditional chemotherapy and radiation. ST-067, administered via subcutaneous injection, might enhance the immune response, making the treatment potentially more powerful and longer-lasting. This combination may provide a more targeted attack on the cancer cells, potentially leading to better outcomes for patients with fewer side effects compared to existing therapies.

What evidence suggests that this trial's treatments could be effective for large B-cell lymphoma?

Research has shown that lisocabtagene maraleucel, or liso-cel, effectively treats relapsed or refractory large B-cell lymphoma. In studies, 90% of patients with certain types of lymphoma responded to the treatment, and 70% achieved complete remission. The treatment has demonstrated lasting results with a good safety profile over three years.

In this trial, participants will receive a combination of liso-cel and ST-067. ST-067 is a newer treatment designed to boost the immune system to fight cancer cells. Although limited data exists on its effectiveness, it aims to enhance the effects of CAR T-cell therapy like liso-cel. Early indications suggest that using ST-067 with liso-cel could improve outcomes for patients with challenging cases of lymphoma. ^{1 4 5 6 7}

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40623279/

Lisocabtagene Maraleucel Versus Standard of Care for ... Results are reported descriptively. With a median follow-up of 33.9 months, median (95% CI) event-free survival was 29.5 months (9.5 to not ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00399

Lisocabtagene Maraleucel Versus Standard of Care for ... At 3-year follow-up, liso-cel confirmed superior, more durable efficacy versus SOC with a favorable safety profile and no new safety signals.

3. ashpublications.org ashpublications.org/bloodadvances/article/9/5/1232/534450/Lisocabtagene-maraleucel-for-relapsed-refractory

Lisocabtagene maraleucel for relapsed/refractory large B-cell ... Among 10 patients with secondary CNS lymphoma, liso-cel was active demonstrating a best overall response of 90% (best CR rate, 70%) with a 12-month PFS of 60%, ...

4. news.bms.com news.bms.com/news/details/2025/Bristol-Myers-Squibb-Presents-First-Data-from-the-Marginal-Zone-Lymphoma-Cohort-of-the-Transcend-FL-Trial-Demonstrating-Deep-and-Durable-Responses-with-Breyanzi-lisocabtagene-maraleucel/default.aspx

Corporate news details 95.5% of patients with relapsed or refractory marginal zone lymphoma (MZL) treated with lisocabtagene maraleucel (liso-cel) achieved a response.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2473952923006894

Cost-effectiveness of second-line lisocabtagene ... Liso-cel shows cost-effectiveness in second-line DLBCL therapy with health care and societal ICERs at $99 669 and $68 212, respectively.

6. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/470/531306/Real-World-RW-Outcomes-of-Lisocabtagene-Maraleucel

Real-World (RW) Outcomes of Lisocabtagene Maraleucel (liso ... Conclusions: Liso-cel continued to demonstrate consistently deep responses in this broad, albeit older, RW pt cohort with 2L R/R LBCL, with early responses ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666636725003768

308 Outcomes of Standard of Care (SOC) Lisocabtagene ... Effectiveness outcomes included ORR, CR rate, duration of response (DOR), PFS, and OS. Safety outcomes included cytokine release syndrome (CRS), immune effector ...