Health TrialsbyHealthPanel

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

ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLuminary Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-69 years

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

Disqualifiers

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

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • LMY-920

    Biological/Vaccine

    CAR T Therapy

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: BAFF CAR TExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
5 years
2

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.

Time frame
5 years

Secondary outcomes

1

Efficacy of the Treatment: SELENA-SLEDAI

The change between baseline and post BAFF CAR-T cell infusion SLE disease activity scores: Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)

Time frame
5 years
2

Efficacy of the Treatment: BILAG

The change between baseline and post BAFF CAR-T cell infusion SLE disease activity scores: British Isles Lupus Assessment Group of SLE clinics (BILAG)

Time frame
5 years
3

Efficacy of the Treatment: PGA

The change between baseline and post BAFF CAR-T cell infusion SLE disease activity scores: Physician Global Assessment (PGA) scores.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luminary Therapeutics

Lead sponsor

Nationwide Children's Hospital

Collaborator

Source ClinicalTrials.gov
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