SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus

Recruiting Phase 1 Phase 2 Interventional Study
REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS Lupus Nephritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Beijing Biotech · Industry
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About This Trial
study evaluates a biomarker-guided strategy to assign adults with refractory SLE to autologous CAR-T therapy targeting either CD19 or BCMA. Participants undergo centralized screening immunophenotyping to determine whether their disease appears B-cell-dominant (CD19-preferred) or plasma-cell-dominant (BCMA-preferred), followed by leukapheresis, lymphodepletion, and a single CAR-T infusion. The main…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 1\. Age 18 to 70 years at consent. 2. Meets 2019 EULAR/ACR classification criteria for SLE, with total score \>= 10. 3\. Active refractory disease at screening, defined by SELENA-SLEDAI \>= 8, or at least one BILAG A domain, or at least two BILAG B domains, or active lupus …
Contacts

shan S Lu, Phd

+86 13076790030

Seni-Lu@beijing-biotech.com

CONTACT