BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus

NCT06340750 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: LMY-920-003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 1 study seeks to examine the safety and recommended phase 2 dose (RP2D) of BAFF-ligand CAR-T cells (LMY-920) in adult patients with refractory systemic lupus erythematosus (SLE). It is hypothesized that BAFF CAR-T cells will be safe and will improve SLE disease activity scores.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• Safety of the Treatment

  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

  5 years

• Recommended Phase 2 Dose (RP2D)

  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.

  5 years

Secondary Outcomes (3)

• Efficacy of the Treatment: SELENA-SLEDAI

  5 years

• Efficacy of the Treatment: BILAG

  5 years

• Efficacy of the Treatment: PGA

  5 years

Study Arms (1)

BAFF CAR T

EXPERIMENTAL

Autologous BAFF CAR T Therapy

Biological: LMY-920

Interventions

LMY-920 BIOLOGICAL

CAR T Therapy

Also known as: BAFF CAR T

BAFF CAR T

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• i. Corticosteroids (CS), Hydroxychloroquine ii. Mycophenolate mofetil (MMF), Methotrexate (MTX), Azathioprine (AZA), Tacrolimus (TAC), Cyclophosphamide (CYC), Rituximab, and/or belimumab b. Active disease due to intolerance of standard therapy (i) and one or more additional therapies (ii).
• c. Steroid-Dependent Disease
• Subjects must meet organ function criteria:
• Creatinine clearance more than or equal to 30 ml/min calculated by the Cockcroft - Gault formula
• Subjects must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 40% on the most recent echocardiogram.
• Adequate pulmonary function with pulse oximetry ≥92% on room air
• Total Bilirubin ≤ 1.5x the institutional upper limit of normal (except in patients with Gilbert's syndrome)
• ALT (SGPT) and AST (SGOT) \< 3x the institutional upper limit of normal

You may not qualify if:

• SLE complicated by:
• Active neuropsychiatric lupus
• Active secondary hemophagocytic lymphohistiocytosis (sHLH)
• Presence of any medical or psychological conditions which may affect patient ability to comply with study protocol requirements and study visits
• Presence of active, untreated infection such as:
• Active microbial infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic. Patients with active tuberculosis must have had at least 4 weeks of appropriate anti-mycobacterial treatment and be asymptomatic.
• Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
• HIV positive test within 8 weeks of screening
• Acute/ongoing neurologic toxicity \> Grade 1 except for a history of controlled seizures or fixed neurologic deficits that have been stable/improving over the past 1 months.
• Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.
• Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy
• Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study. Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \< 1% per year during the treatment period and for at least 6 months after the CAR-T cell infusion.
• A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
• Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
• Men who will not agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm, as defined below:

Sponsors & Collaborators

• Luminary Therapeutics: lead
• Nationwide Children: collaborator

Study Sites (1)

Nationwide Children's

Columbus, Ohio, 43205, United States

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dean Lee, PhD

  Nationwide Children

  STUDY CHAIR

Central Study Contacts

Matthew A Spear, MD

CONTACT

8583528557; maspear@luminarytx.com

Jeff Liter, MBA

CONTACT

612-I 309-7653; j.liter@luminarytx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 1, 2024
• Study Start: April 1, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)