RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I Study of BAFF CAR-T Cells (LMY-920) for Treatment of Systemic Lupus Erythematosus

Quick Facts

Study Start:2025-04-01

Study Completion:2026-06-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06340750

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: * Subjects must meet organ function criteria: 1. Creatinine clearance more than or equal to 30 ml/min calculated by the Cockcroft - Gault formula 2. Subjects must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 40% on the most recent echocardiogram. 3. Adequate pulmonary function with pulse oximetry ≥92% on room air 4. Total Bilirubin ≤ 1.5x the institutional upper limit of normal (except in patients with Gilbert's syndrome) 5. ALT (SGPT) and AST (SGOT) \< 3x the institutional upper limit of normal	* 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).

Inclusion Criteria

Exclusion 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:
* Subjects must meet organ function criteria:
1. Creatinine clearance more than or equal to 30 ml/min calculated by the Cockcroft - Gault formula
2. Subjects must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 40% on the most recent echocardiogram.
3. Adequate pulmonary function with pulse oximetry ≥92% on room air
4. Total Bilirubin ≤ 1.5x the institutional upper limit of normal (except in patients with Gilbert's syndrome)
5. ALT (SGPT) and AST (SGOT) \< 3x the institutional upper limit of normal

* 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).

Contacts and Locations

Study Contact

Matthew A Spear, MD

CONTACT

8583528557

maspear@luminarytx.com

Jeff Liter, MBA

CONTACT

612-I 309-7653

j.liter@luminarytx.com

Principal Investigator

Dean Lee, PhD

STUDY_CHAIR

Nationwide Children

Study Locations (Sites)

Nationwide Children's

Columbus, Ohio, 43205

United States

Collaborators and Investigators

Sponsor: Luminary Therapeutics

Dean Lee, PhD, STUDY_CHAIR, Nationwide Children

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01

Study Completion Date2026-06-15

Study Record Updates

Study Start Date2025-04-01

Study Completion Date2026-06-15

Terms related to this study

Additional Relevant MeSH Terms

Systemic Lupus Erythematosus