Lymphoma, Non-HodgkinPhase 1BAF_FRontier-1NCT07101328
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
A Phase 1 study testing LY4152199 - IV in people with Lymphoma, Non-Hodgkin and B-cell Lymphoma, run by Eli Lilly and Company at 51 sites in 12 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, B-cell Lymphoma, Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- LY4152199 - IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 51 sitesin 12 countries
- Study dates
- 28 May 2026to Sep 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 laboratory testing.
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- 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 have histologically confirmed relapsed/refractory diffuse large B-cell lymphoma (DLBCL) de novo or transformed from follicular lymphoma (FL).
Who cannot join
- 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 alopecia.
- Autologous stem cell transplantation within 100 days of this study for post autologous transplant individuals.
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- 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 organ function criteria.
- 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.
Trial locations and contacts
51 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
51 sites in 12 countries
United States23 sites, 23 recruiting
- Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
- Recruiting
University of Colorado Denver - School of Medicine - Anschutz Medical Campus
Aurora, Colorado, 80045-2559
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, 60637
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75244
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Recruiting
City of Hope
Duarte, California, 91010
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
- Recruiting
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Not yet recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
- Recruiting
Yale University School of Medicine - Yale Cancer Center
New Haven, Connecticut, 06520-8028
- Recruiting
New York University (NYU) Clinical Cancer Center
New York, New York, 10016
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
- Recruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
- Recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
- Not yet recruiting
Intermountain Healthcare
Salt Lake City, Utah, 84111
- Recruiting
Swedish Cancer Institute (SCI)
Seattle, Washington, 98104
Japan4 sites, 4 recruiting
- Not yet recruiting
National Cancer Center Hospital East
Chiba, 277-8577
- Recruiting
Okayama University Hospital
Okayama, 700-8558,
- Not yet recruiting
National Cancer Center Hospital
Tokyo, 104-0045
- Recruiting
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Canada3 sites, 3 recruiting
- Not yet recruiting
Lady Davis Institute for Medical Research Jewish General Hospital
Montreal, H3T 1E2
- Not yet recruiting
University Health Network (UHN) - Princess Margaret Cancer Centre
Toronto, M5G 1Z5
- Not yet recruiting
BC Cancer - Vancouver
Vancouver, V5Z 1L3
Germany3 sites, 3 recruiting
- Not yet recruiting
Charite Universitaetsmedizin Berlin
Berlin, 10117
- Not yet recruiting
LMU Klinikum Muenchen-Campus Grosshadern
München, 80336
- Not yet recruiting
Universitaetsklinikum Muenster
Münster, 48149
Italy3 sites, 3 recruiting
- Not yet recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola
Bologna, 40138
- Not yet recruiting
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, 80131
- Not yet recruiting
Istituto Clinico Humanitas
Rozzano, 20089
Spain3 sites, 3 recruiting
- Not yet recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
- Not yet recruiting
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, 08908
- Not yet recruiting
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid, 28040
Australia2 sites, 2 recruiting
- Not yet recruiting
The Alfred Hospital
Melbourne, VIC, 3004
- Recruiting
Linear Clinical Research
Nedlands, 6009
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aarhus University Hospital
Aarhus, N 8200
- Not yet recruiting
Center for Cancer and Organ Diseases - Rigshospitalet
Copenhagen, 2100
France2 sites, 2 recruiting
- Not yet recruiting
CHU de Lille - Hopital Claude Huriez
Lille, 59037
- Not yet recruiting
AP-HP Hopital Saint-Louis
Paris, 75010
Poland2 sites, 2 recruiting
- Not yet recruiting
Pratia MCM Krakow
Krakow, 30-727
- Not yet recruiting
AIDPORT Sp. z o.o.
Skorzewo, 60-185
South Korea2 sites, 2 recruiting
- Not yet recruiting
Seoul National University Hospital
Seoul, 03080
- Not yet recruiting
Asan Medical Center
Seoul, 05505
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
- Not yet recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
About this study
Official title: BAF_FRontier-1, A First-in-Human, Phase 1 Trial to Assess Safety, Tolerability, and Preliminary Efficacy of LY4152199, a B-cell Activation Factor Receptor (BAFF-R) T-Cell Engager Bispecific Antibody in Adult Participants With Previously Treated B-cell Malignancies
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.
- Conditions
- Lymphoma, Non-Hodgkin, B-cell Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-cell Marginal Zone, Waldenstrom Macroglobulinemia
- Being tested
- LY4152199 - IV
- Keywords
- B- cell activating factor receptor (BAFFR), Bispecific antibody
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Waldenstrom Macroglobulinemia, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4152199 - IVDrug
Administered by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Dose Escalation (Cohort A) - DLBCL and FL | Experimental | Escalating doses of LY4152199 administered intravenously (IV) Receives: Drug: LY4152199 - IV |
| Phase 1: Dose Optimization (Cohort B1) - DLBCL | Experimental | Two or more doses of LY4152199 (evaluated during dose escalation) administered IV Receives: Drug: LY4152199 - IV |
| Phase 1: Dose Optimization (Cohort B2) - FL | Experimental | Two or more doses of LY4152199 (evaluated during dose escalation) administered IV Receives: Drug: LY4152199 - IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 - Number of Participants with Dose Limiting Toxicities (DLT) of LY4152199
Measured: Cycle 1 Day 1 through Cycle 2 Day 8 (35 days)
Secondary outcomes (6)
Phase 1 - Pharmacokinetics (PK): Area under the Concentration versus Time Curve (AUC) of LY4152199
Measured: Baseline up to approximately 91 weeks
Phase 1- PK: Maximum drug Concentration (Cmax) of LY4152199
Measured: Baseline up to approximately 91 weeks
Phase 1 - Overall Response Rate (ORR): Percentage of Participants with Best Overall Response (BOR) of Partial Response (PR) or Better.
Assessed by the Investigator per disease-specific response criteria as appropriate to disease indication.
Measured: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
Phase 1 - Duration of Response (DOR)
Time between the date of first documented response (PR or better) to the date of first disease progression or death due to any cause, whichever occurs first
Measured: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
Phase 1- Time to Response (TTR)
Time from first dose date (or randomization date for the dose optimization cohort) to the date of first documented response (PR or better)
Measured: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
Phase 1 - Progression Free Survival (PFS)
Time from first dose date (or randomization date for the dose optimization cohort) to the date of first documented disease progression or death due to any cause, whichever occurs first
Measured: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start28 May 2026
- Primary completionApr 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101328
- Sponsor's protocol ID
- 27701
- Other IDs
- 2025-524180-20-00, J6N-MC-JUCA, 2025
- Acronym
- BAF_FRontier-1
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No