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LMY-920

Phase 1

Systemic Lupus Erythematosus | Monoclonal antibody | Immunology |cbdMD, Inc.|Last Updated: Jun 3, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

LMY-920 · 1 trial · 1 indication

Phase 1 1
NCT06340750BAFF CAR-T Cells (LMY-920) for Systemic Lupus ErythematosusSystemic Lupus Erythematosus
RECRUITING18 Analytics
PHASE1RECRUITING
BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus
Systemic Lupus ErythematosusUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety of the Treatment
5 years

The rate of adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (National Cancer Institute) and rate of dose limiting toxicities after treatment with autologous BAFF CAR-T cells in adults with refractory SLE

Recommended Phase 2 Dose (RP2D)
5 years

A dose of autologous BAFF CAR-T cells in adults with refractory SLE less than or equal to that at which less than or equal to 1/6 patients experience dose limiting toxicities.

Secondary Endpoints

Efficacy of the Treatment: SELENA-SLEDAI
5 years
Efficacy of the Treatment: BILAG
5 years
Efficacy of the Treatment: PGA
5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BAFF CAR TEXPERIMENTALAutologous BAFF CAR T Therapy

Interventions

NameTypeDescription
LMY-920BIOLOGICALCAR T Therapy
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age 18-69 years * Confirmed Systemic Lupus Erythematosus (SLE) as per Systemic Lupus International Collaborating Clinics (SLICC) 2012 Criteria with one or more of the following: a. Active disease despite use of standard therapy (i) and one or more additional therapies (ii)....

Countries:United States
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Frequently asked questions about LMY-920

What is LMY-920 used for?

LMY-920 is an investigational monoclonal antibody being developed for the treatment of Systemic Lupus Erythematosus (SLE). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in a clinical trial enrolling adult patients with SLE.

Who makes LMY-920?

LMY-920 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting a Phase 1 clinical trial of this investigational therapy for Systemic Lupus Erythematosus.

What phase is LMY-920 in?

LMY-920 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is actively recruiting participants with Systemic Lupus Erythematosus.

What clinical trials is LMY-920 in?

LMY-920 is being studied in a Phase 1 clinical trial registered as NCT06340750, titled 'BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus'. This single-center, uncontrolled trial is recruiting 18 adult patients in the United States and is not yet completed.

Is LMY-920 the same as BAFF CAR-T cells?

Yes, LMY-920 is also referred to as BAFF CAR-T cells in the clinical trial context. The Phase 1 study NCT06340750 explicitly names 'BAFF CAR-T Cells (LMY-920)' as the investigational therapy, indicating that LMY-920 is a CAR-T cell product targeting BAFF for the treatment of Systemic Lupus Erythematosus.