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New treatment option for Recurrent Diffuse Large B-Cell Lymphoma
Official title ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed/Refractory Large B-Cell Lymphoma
ClinicalTrials.gov ID: NCT07098364
What this study is testing
What is Vevoctadekin?
Vevoctadekin is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for recurrent diffuse large b-cell lymphoma.
Also referred to as ST-067, ST 067.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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]...
- 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%
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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 people with lymphomatous infiltration of the liver) and total bilirubin =\< 2 (or \< 3.0 for...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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...
- History of solid organ transplantation
- Active, serious, and uncontrolled infection(s)
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.