RecruitingPhase 1

A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)

China38 participantsStarted 2026-01-29

Plain-language summary

This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects voluntary agreement to provide written informed consent.
. Aged 18 to 70 years, either sex.
. Adequate organ function meet screening criteria.
. Positive test for cluster of differentiation antigen 19 (CD19).

Exclusion criteria

. Active infections such as hepatitis and tuberculosis.
. Other autoimmune diseases.
. Serious underlying diseases such as tumor, uncontrolled diabetes.
. Female subjects who were pregnant, breastfeeding.
. Those with a history of major organ transplantation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

Timeframe: 2 years after LUCAR-G79D infusion (Day 1)

Incidence of dose-limiting toxicity (DLT)

Timeframe: 2 years after LUCAR-G79D infusion (Day 1)

Maximum concentration (Cmax) in peripheral blood

Timeframe: 2 years after LUCAR-G79D infusion (Day 1)

Time of maximum concentration (Tmax) in peripheral blood

Timeframe: 2 years after LUCAR-G79D infusion (Day 1)

Area under the concentration-time curve (AUC) in peripheral blood

Timeframe: 2 years after LUCAR-G79D infusion (Day 1)

Recommended Dose regimen finding

Timeframe: 2 years after LUCAR-G79D infusion (Day 1)

Trial details

NCT IDNCT07331272

SponsorNanjing Legend Biotech Co.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-01-31

View on ClinicalTrials.gov More Systemic Lupus Erythematosus (SLE) trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects voluntary agreement to provide written informed consent.
. Aged 18 to 70 years, either sex.
. Adequate organ function meet screening criteria.
. Positive test for cluster of differentiation antigen 19 (CD19).

Exclusion criteria

. Active infections such as hepatitis and tuberculosis.
. Other autoimmune diseases.
. Serious underlying diseases such as tumor, uncontrolled diabetes.
. Female subjects who were pregnant, breastfeeding.
. Those with a history of major organ transplantation.

What they're measuring

Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

Timeframe: 2 years after LUCAR-G79D infusion (Day 1)

Incidence of dose-limiting toxicity (DLT)

Timeframe: 2 years after LUCAR-G79D infusion (Day 1)

Maximum concentration (Cmax) in peripheral blood

Timeframe: 2 years after LUCAR-G79D infusion (Day 1)

Time of maximum concentration (Tmax) in peripheral blood

Timeframe: 2 years after LUCAR-G79D infusion (Day 1)

Area under the concentration-time curve (AUC) in peripheral blood

Timeframe: 2 years after LUCAR-G79D infusion (Day 1)

Recommended Dose regimen finding

Timeframe: 2 years after LUCAR-G79D infusion (Day 1)