NCT07101328RecruitingPhase 1
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 215 (estimated)
- First submitted
- 28 Jul 2025
- Start date
- 28 May 2026
- Primary completion date
- Apr 2027
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Follicular lymphoma, Mantle cell lymphoma
- NCT number
- NCT07101328
- EU CT number
- 2025-524180-20-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 215
- From 28 May 2026 to the primary completion date, Apr 2027
- 51 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- Vaccination with a live vaccine within 4 weeks prior to signing informed consent form (ICF).
- Prior treatment with B-cell activating factor receptor (BAFF-R) directed therapies (e.g., monoclonal antibody, CAR-T or bispecific antibody).
Other illness
- Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- 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
- Have current or had a history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins).
- Known hypersensitivity to any component or excipient of LY4152199.
Lab values
- 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).
Other
- All Participants
- Known or suspected central nervous system (CNS) involvement by systemic lymphoma.
- Pregnant and/or planning to breastfeed during the trial or within 90 days of the last dose of study intervention.
Who the study is looking for
- 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.
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (51)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne, VIC | Australia | Recruiting |
| Linear Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| Lady Davis Institute for Medical Research Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| University Health Network UHN Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| BC Cancer - Vancouver Coordinator of this site? Confirm its status | Vancouver | Canada | Not yet recruiting |
| Charité - Universitaetsmedizin Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| LMU Klinikum Muenchen-Campus Grosshadern Coordinator of this site? Confirm its status | München | Germany | Not yet recruiting |
| Universitaetsklinikum Muenster Coordinator of this site? Confirm its status | Münster | Germany | Not yet recruiting |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Not yet recruiting |
| Center for Cancer and Organ Diseases - Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Not yet recruiting |
| Hospital Universitario Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Institut Catala d'Oncologia - L'Hospitalet Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| CHU de Lille - Hopital Claude Huriez Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| AP-HP Hôpital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Leeds Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Leeds | United Kingdom | Not yet recruiting |
| Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Not yet recruiting |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola Coordinator of this site? Confirm its status | Bologna | Italy | Not yet recruiting |
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Istituto Clinico Humanitas Coordinator of this site? Confirm its status | Rozzano | Italy | Not yet recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Chiba | Japan | Not yet recruiting |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Recruiting |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Not yet recruiting |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Pratia MCM Krakow Coordinator of this site? Confirm its status | Krakow | Poland | Not yet recruiting |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo | Poland | Not yet recruiting |
| University Of Michigan Comprehensive Cancer Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| University of Colorado Denver - School of Medicine - Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| The University of Chicago Medical Center (UCMC) Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| University of Texas, Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Colorado Blood Cancer Institute Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| University of Kansas Cancer Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Froedtert Hospital and the Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Not yet recruiting |
| Yale University School of Medicine - Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| New York University (NYU) Clinical Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Pennsylvania/Abramson Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Intermountain Healthcare Coordinator of this site? Confirm its status | Salt Lake City | United States | Not yet recruiting |
| Swedish Cancer Institute (SCI) Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.