LMY-920 CAR-T Cells for Systemic Lupus Erythematosus
This study is testing a new type of cell therapy called LMY-920 (BAFF CAR-T cells) for adults with systemic lupus erythematosus (SLE) that hasn't responded to standard treatments. LMY-920 uses your own immune cells, modified to target specific cells involved in lupus. The main goals are to see how safe LMY-920 is and to find the best dose for future studies. Researchers also hope to see if this treatment can improve lupus symptoms. You might be able to join if you are between 18 and 69 years old and have confirmed SLE that is still active despite current medications. The study plans to enroll 18 participants, but its current status is unclear.
- Study design
- This is an open-label (meaning you and your doctors will know what treatment you receive) Phase 1 study to find a safe and effective dose. It will involve about 18 participants, with the possibility of expanding to 40.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 5 years after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06340750
BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus
Recruiting
PHASE1Ages 18–65InterventionalTreatmentLuminary Therapeutics
~18 participants
Updated 2025-06-03 on ClinicalTrials.gov
What's tested:LMY-920
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of the Treatment
Measured over 5 years
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Dean Lee, PhD · STUDY_CHAIR · Nationwide Children's Hospital
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
Subjects must meet organ function criteria:
Exclusion
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:
With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 6 months after the CAR-T cell infusion. Men must refrain from donating sperm during this same period.
With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the CAR- T cell infusion to avoid potential embryonal or fetal exposure. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Patients receiving a live vaccines within the last two weeks.
A minimum of 28 days must have elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection.
Concurrent use of high dose systemic steroids and/or T cell directed immune suppression. Subjects must discontinue T cell targeted therapy \>3 weeks and wean prednisone dose to ≤10 mg/day prior to leukapheresis.
Previous treatment with any gene or adoptive cell therapy products.
Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, serious arrhythmia, HIV, seizure disorder, cerebrovascular disease, psychiatric disease), that may interfere with the patient's ability to tolerate the therapy or comply with assessments.
Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast). Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial (e.g. Low Gleason score prostate Cancer).
What this trial measures
- Safety of the Treatment5 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.