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New treatment option for Lymphoma, Non-Hodgkin
Official title A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
ClinicalTrials.gov ID: NCT07101328
What this study is testing
What is LY4152199 - IV?
LY4152199 - IV is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lymphoma, non-hodgkin.
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
- The purpose of this study is to find the best dose of the drug and measure the safety and efficacy of LY4152199 in participants with previously treated B-cell malignancies. Participants will have the option to continue taking LY4152199 until the study ends.
- Phase 1: an early, usually small safety study
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
- Must have a diagnosis of either follicular lymphoma or diffuse large B-cell lymphoma.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Estimated life expectancy of greater than or equal to (≥)12 weeks as judged by the Investigator.
- Participants with select tumor types must have measurable or assessable disease as defined below:
- Participants with lymphoma must have at least 1 bi-dimensionally measurable lesion or in the absence of measurable lymphadenopathy, documentation of...
You likely can't join if
- All Participants
- Known or suspected peripheral blood involvement by malignant cells with an absolute lymphocyte count of greater than or equal to (≥) 5000 cells per...
- Known or suspected central nervous system (CNS) involvement by systemic lymphoma.
- Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- Any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)...
- Autologous stem cell transplantation within 100 days of this study for post autologous transplant individuals.
See the full eligibility criteria
- Must have a diagnosis of either follicular lymphoma or diffuse large B-cell lymphoma.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Estimated life expectancy of greater than or equal to (≥)12 weeks as judged by the Investigator.
- Participants with select tumor types must have measurable or assessable disease as defined below:
- Participants with lymphoma must have at least 1 bi-dimensionally measurable lesion or in the absence of measurable lymphadenopathy, documentation of bone marrow involvement.
- Participants with Waldenstrom macroglobulinemia (WM) must have measurable disease, defined as the presence of serum IgM with a minimum IgM level of greater than (\>)2 times (×) upper limit of normal (ULN) based on local...
- Must be able to comply with inpatient/outpatient treatment, laboratory monitoring, and required clinic visits for the duration of trial participation.
- Must have adequate organ function. Phase 1 Dose Escalation (Cohort A) Participants - Must have histologically confirmed relapsed/refractory B-cell malignancy. Phase 1 Dose Optimization (Cohort B) Participants \- Must...
- All Participants
- Known or suspected peripheral blood involvement by malignant cells with an absolute lymphocyte count of greater than or equal to (≥) 5000 cells per microliter (μL).
- Known or suspected central nervous system (CNS) involvement by systemic lymphoma.
- Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- Any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 2 at the time of starting trial treatment except for...
- Autologous stem cell transplantation within 100 days of this study for post autologous transplant individuals.
- Residual symptoms of neurotoxicity or cytopenias from prior chimeric antigen receptor T-cell therapy (CAR-T) or bispecifics. Exception: Cytopenia related to prior CAR-T or bispecifics allowed if they meet the adequate...
- Known or suspected history of macrophage activation syndrome or hemophagocytic lymphohistiocytosis (HLH).
- Active second malignancies, unless in remission, with life expectancy greater than 2 years with Sponsor approval.
- History of autoimmune disease
- Significant cardiovascular disease
- Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other clinically significant active disease process
- Vaccination with a live vaccine within 4 weeks prior to signing informed consent form (ICF).
- Have current or had a history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins).
- Prior treatment with B-cell activating factor receptor (BAFF-R) directed therapies (e.g., monoclonal antibody, CAR-T or bispecific antibody).
- Pregnant and/or planning to breastfeed during the trial or within 90 days of the last dose of study intervention.
- Known hypersensitivity to any component or excipient of LY4152199.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
+ 25 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Duarte, California, United States; Aurora, Colorado, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Chicago, Illinois, United States; Iowa City, Iowa, United States and 39 more location(s). 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.