BAFF CAR-T Cells for Refractory Autoimmune Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory autoimmune disease, even after relapse following other treatments. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against refractory autoimmune disease using a BAFF CAR-T cell manufacturing process with or without lymphodepletion regimen.
Are You a Good Fit for This Trial?
This trial is for adults with severe autoimmune diseases like lupus, rheumatoid arthritis, dermatomyositis, or scleroderma that have not improved with standard treatments. Participants must be in generally stable health aside from their autoimmune disease.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- LMY-922
Trial Overview
The study is testing a new cell therapy called BAFF CAR-T cells (LMY-922) to see if it can safely treat people whose autoimmune diseases haven't responded to other therapies. Some participants may also receive medicines to lower immune cells before the treatment.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Evaluation of LMY-922 fractionated dosing with or without lymphodepletion in Part C will be initiated only after safety, tolerability, lymphodepletion regimen parameters and dose parameters are established in Part A and Part B. Participants will receive three equal fractionated doses of LMY-922 administered approximately 3 weeks apart (Days 0, 21, and 42). The total cumulative dose will be equivalent to the dose selected in Parts A and B.
Evaluation of LMY-922 without lymphodepletion in Part B will be initiated only after safety, tolerability, and dose parameters are established in Part A.
Open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose (MTD) of LMY-922 will be determined using dose-escalation 3+3 design. Dose Level -1: 75×10\^6 CAR-T cells Dose Level 1: 150×10\^6 CAR-T cells Dose Level 2: 300×10\^6 CAR-T cells Dose Level 3: 450×10\^6 CAR-T cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Luminary Therapeutics
Lead Sponsor
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