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ST-067 with CAR T-Cell Therapy for Lymphoma

This study is testing a new combination treatment for large B-cell lymphoma (LBCL) that has returned or hasn't responded to previous treatments. It combines ST-067, which is a modified version of a natural substance in the body that may help your immune system fight cancer, with liso-cel. Liso-cel is a CAR T-cell therapy, which uses your own immune cells to target and kill cancer cells. The study aims to find the safest and most effective dose of ST-067 when given with liso-cel, and to see how well this combination works. About 33 people are expected to join this study. The study will look at side effects and how well the treatment works over four years.

Study design
This is a Phase I/II study. It starts with a dose-escalation phase to find the right dose of ST-067, followed by a Phase II study. Approximately 33 participants are planned for enrollment.
What's involved
You would undergo procedures like bone marrow aspirations and biopsies, CT scans, and echocardiograms. You would also receive liso-cel intravenously and ST-067 injections weekly for up to 8 doses. Blood samples will be collected throughout the study.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will have follow-up visits at 3, 6, 9, and 12 months after CAR T-cell infusion. You will then be followed per standard of care long-term until you die, are lost to follow-up, or withdraw consent.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07098364

ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed/Refractory Large B-Cell Lymphoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Fred Hutchinson Cancer Center
~33 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:VevoctadekinBone Marrow AspirationBone Marrow BiopsyComputed TomographyEchocardiography TestLeukapheresis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over Up to 4 years
+3 more outcomes measured

Conditions

Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Recurrent Grade 3b Follicular Lymphoma
Recurrent High-Grade B-Cell Lymphoma
Recurrent Indolent B-Cell Non-Hodgkin Lymphoma
Recurrent Primary Mediastinal Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Refractory Grade 3b Follicular Lymphoma
Refractory High-Grade B-Cell Lymphoma
Refractory Indolent B-Cell Non-Hodgkin Lymphoma
Refractory Primary Mediastinal Large B-Cell Lymphoma

Explore related trials

Diffuse Large B-Cell LymphomaFollicular LymphomaHigh Grade B-Cell LymphomaLarge B-cell lymphomaPrimary Mediastinal Large B-Cell Lymphoma

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Alexandre V. Hirayama, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Immunotherapy Intake Coordinator
[email protected]
206-606-4668
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Male or female \>= 18 years of age at the time of consent
Patients with LBCL (including diffuse large B-cell lymphoma \[DLBCL\] not otherwise specified \[including DLBCL arising from indolent lymphoma\], high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B) with at least 2 lines of systemic therapy and an Food and Drug Administration (FDA)-approved indication for treatment with liso-cel
Fluorodeoxyglucose (FDG)-avid disease on PET imaging before lymphodepletion or pathology evidence of active disease
Evidence of CD19 expression on any prior or current tumor specimen or a high likelihood of CD19 expression based on disease histology
Karnofsky performance status \>= 60%
Adequate bone marrow function for lymphodepletion chemotherapy defined as: absolute neutrophil count (ANC) \>= 1000 cells/mm\^3, platelets \>= 50,000 cells/mm\^3, and hemoglobin \>= 8 g/dL, unless the cytopenias are due to bone marrow involvement by lymphoma in the opinion of the principal investigator (PI)
Calculated creatinine clearance (Cockcroft/Gault) \> 30 mL/min/1.73 m\^2
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN) (or \< 5 x ULN for subjects with lymphomatous infiltration of the liver) and total bilirubin =\< 2 (or \< 3.0 for subjects with Gilbert's syndrome, lymphomatous infiltration of the liver, or hemolysis)
Adequate pulmonary function based on pulmonary function testing (PFT), defined as forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity (FVC) ratio of \>= 60% of predicted value and diffusing capacity of the lung for carbon monoxide (DLCO; corrected) \>= 40% of predicted value
Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) \>= 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA)
Women of reproductive potential (defined as all women physiologically capable of becoming pregnant) must agree to use suitable methods of contraception for at least 30 days after the last dose of study therapy (ST-067)
Males who have partners of reproductive potential must agree to use an effective barrier contraceptive method for at least 90 days after the last dose of study therapy (ST-067)
Ability to understand and provide informed consent
Able and willing to comply with study visit schedule and procedures, including tumor biopsy where feasible and with acceptable risk

Exclusion

Planned use of out-of-specification liso-cel product
History of another malignancy. The following are exceptions to this criterion:
Adequately treated basal cell or squamous cell carcinoma of the skin.
In situ prostate, ductal breast carcinoma breast, and cervical carcinoma.
Adequately treated papillary, noninvasive bladder cancer.
Other adequately treated stage 1 or 2 cancers currently in complete remission.
Any other cancer that has been in remission for \>= 2 years
Planned use of therapeutic doses of corticosteroids (\> 20 mg/day prednisone or equivalent) or other systemic immunosuppression within 7 days prior to leukapheresis or within 72 hours prior to liso-cel infusion. Topical and/or inhaled steroids are permitted
Prior treatment with any CD19 CAR T-cell therapy
For allogeneic hematopoietic cell transplant recipients, active graft versus host disease (GVHD) and/or systemic GVHD therapy within 30 days prior to planned leukapheresis
Known active hepatitis B (detectable hepatitis B deoxyribonucleic acid \[DNA\]) or hepatitis C (detectable hepatitis C ribonucleic acid \[RNA\])
Known human immunodeficiency virus (HIV) infection
Pregnant or breastfeeding women
Prior treatment with any IL-1 or IL-18 agonist and/or biosimilar agents, or an investigational agent within 4 weeks or 5 half-lives, whichever is shorter, prior to start of lymphodepletion
Active autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., ulcerative colitis, Crohn's disease\], celiac disease, or other serious chronic gastrointestinal conditions associated with diarrhea, autoimmune vasculitis, systemic lupus erythematosus, Wegener syndrome \[granulomatosis with polyangiitis\], myasthenia gravis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.) requiring immunosuppressive therapy. The following are exceptions to this criterion:
Vitiligo.
Alopecia.
Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
Type 1 diabetes mellitus.
Psoriasis not requiring systemic treatment.
Conditions considered to be low risk of serious deterioration by the PI
History of any one of the following cardiovascular conditions within the past 6 months, unless clearance by a cardiologist is obtained: class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, or unstable angina. History of other clinically significant cardiac disease that, in the opinion of the PI or designee, is a contraindication to study treatment is also excluded
Significant electrocardiogram (ECG) abnormalities, including unstable cardiac arrhythmia requiring medication, second-degree atrioventricular (AV) block type II, third-degree AV block, \>= grade 2 bradycardia, or QT interval corrected using Fridericia's formula \> 500 ms irrespective of gender
History or presence of clinically relevant central nervous system (CNS) pathology, such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis that in the opinion of the PI is a contraindication to study treatment.
Patients with active parenchymal CNS involvement by malignancy will be excluded. Patients with prior or current secondary leptomeningeal CNS disease are eligible. CNS disease prophylaxis must be stopped at least 1 week prior to liso-cel infusion
History of solid organ transplantation
Active, serious, and uncontrolled infection(s)

What this trial measures

  • Incidence of adverse events (AEs)Up to 4 years

    Will be graded in severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with the exception of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, which will be graded according to the American Society for Transplantation and Cellular Therapy consensus criteria. The type, frequency, and severity of AEs and laboratory abnormalities will be listed and summarized.

  • Dose limiting toxicities (DLT)Up to 21 days following the first vevoctadekin (ST-067) dose

    Will be graded in severity according to the NCI CTCAE version 5.0. Will be summarized based on the DLT evaluable population. Final DLT rates at each dose level will be estimated by isotonic regression by applying the pooled adjacent violators algorithm. The target toxicity rate is 30%.

  • Optimal biological regimenUp to 4 years

    Will be assessed based on safety and tolerability, confirmation of maximum target engagement, optimal biological effects without undesirable clinical effects, pharmacokinetics parameters, and biological response data.

  • Complete response (CR) rateAt 3 months after liso-cel infusion

    Will be assessed by Lugano criteria. Will be summarized along with the 2-sided 95% exact Clopper-Pearson confidence interval (CI) based on the efficacy-evaluable population.