ClinicalTrials.gg
RecruitingNCT07101328BAF_FRontier-1Updated Nov 4, 2026

A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )

A Phase 1 interventional study of LY4152199 - IV in Lymphoma, Non-Hodgkin, B-cell Lymphoma and Lymphoma, Large B-Cell, Diffuse, sponsored by Eli Lilly and Company. Recruiting at 51 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Updated Nov 4, 2026Site recruiting status changedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
215
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lymphoma, Non-Hodgkin
  • B-cell Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Follicular
  • Lymphoma, B-cell Marginal Zone
  • Waldenstrom Macroglobulinemia
  • Lymphoma, Mantle Cell

Keywords

  • B- cell activating factor receptor (BAFFR)
  • Bispecific antibody
03

In context

Lymphoma, Non-Hodgkin

2,287 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 287 are open to participants now.

This study's planned enrollment of 215 is above the median of 40 across 1,883 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must have a diagnosis of either follicular lymphoma or diffuse large B-cell lymphoma.
  • Must have an (ECOG) performance status of 0 or 1.
  • Estimated 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 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 (×) (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 confirmed B-cell .

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).

Exclusion criteria

Exclusion Criteria:

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) (CTCAE) version 5.0 Grade 2 at the time of starting trial treatment except for alopecia.
  • 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.
  • Known or suspected history of macrophage activation syndrome or hemophagocytic lymphohistiocytosis (HLH).
  • Active second , unless in remission, with greater than 2 years with Sponsor approval.
  • History of disease
  • Significant cardiovascular disease
  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other active disease process
  • Vaccination with a within 4 weeks prior to signing 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 to any component or of LY4152199.
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
215 participants (estimated)

Study arms

  • Experimental
    Phase 1: Dose Escalation (Cohort A) - DLBCL and FL

    Escalating doses of LY4152199 administered intravenously (IV)

    Drug: LY4152199 - IV

  • Experimental
    Phase 1: Dose Optimization (Cohort B1) - DLBCL

    Two or more doses of LY4152199 (evaluated during dose escalation) administered IV

    Drug: LY4152199 - IV

  • Experimental
    Phase 1: Dose Optimization (Cohort B2) - FL

    Two or more doses of LY4152199 (evaluated during dose escalation) administered IV

    Drug: LY4152199 - IV

Interventions

  • DrugLY4152199 - IV

    Administered by IV infusion

06

What researchers measure

Primary outcomes

  1. Phase 1 - Number of Participants with Dose Limiting Toxicities (DLT) of LY4152199

    Time frame: Cycle 1 Day 1 through Cycle 2 Day 8 (35 days)

Secondary outcomes

  1. Phase 1 - Pharmacokinetics (PK): Area under the Concentration versus Time Curve (AUC) of LY4152199

    Time frame: Baseline up to approximately 91 weeks

  2. Phase 1- PK: Maximum drug Concentration (Cmax) of LY4152199

    Time frame: Baseline up to approximately 91 weeks

  3. 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.

    Time frame: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy

  4. 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

    Time frame: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy

  5. 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)

    Time frame: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy

  6. 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

    Time frame: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy

07

Study locations

25 of 51 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Apr 2027, 11 months after the start.

Of 163 industry-sponsored phase 1 interventional studies under Lymphoma, Non-Hodgkin, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's planned 11 months is below that.

Counting every sponsor, half of 286 studies reached it within 53 months; a quarter within 38 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2025
First posted
Aug 3, 2025
StartActual
May 28, 2026
Primary completionEst.
Apr 2027
CompletionEst.
Sep 2029
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites changed recruiting status (2 now recruiting)
Show 2 sites
  • Linear Clinical Research · Nedlands, AustraliaNot yet recruiting→Recruiting
  • The Alfred Hospital · Melbourne, VIC, AustraliaNot yet recruiting→Recruiting
across 2 updates, Oct 8, 2026 – Nov 4, 2026
Show all 2 updates
  1. Nov 4, 2026
    The Alfred Hospital is now Recruiting
    + 1 other change: verification date
  2. Oct 8, 2026
    Linear Clinical Research is now Recruiting
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07101328
Responsible party
Sponsor
First posted
Aug 3, 2025
Start date
May 28, 2026
Primary completion
Apr 2027 (estimated)
Completion
Sep 2029 (estimated)
Last update
Nov 4, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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