Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
NCT07523542

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

Led by Beijing Biotech · Updated on 2026-04-13

24

Participants Needed

1

Research Sites

137 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 goals are to assess safety, determine a recommended Phase 2 dose within each arm, and estimate remission rates by Week 24.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 70 years at consent
  • Meets 2019 EULAR/ACR classification criteria for SLE with total score ≥ 10
  • 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 nephritis with significant proteinuria and active urinary sediment
  • Inadequate response, intolerance, or contraindication to at least 2 prior standard systemic regimens including at least 1 immunosuppressant or biologic for SLE or lupus nephritis
  • Demonstrable targetable biology and assignment to CD19 arm for B-cell dominant disease or BCMA arm for plasma-cell dominant disease or persistent serologic activity after prior B-cell depletion
  • If active lupus nephritis present, biopsy-proven class III, IV, V, or mixed proliferative/membranous lupus nephritis within previous 24 months, or clinical confirmation if biopsy unsafe
  • Adequate organ function with hemoglobin ≥ 8.5 g/dL, ANC ≥ 1.0 x 10^9/L, platelets ≥ 50 x 10^9/L, AST/ALT ≤ 2.5 x ULN, creatinine clearance ≥ 30 mL/min, bilirubin ≤ 2.0 mg/dL unless explained, and LVEF ≥ 50%
  • Adequate venous access and eligibility for leukapheresis
  • Negative pregnancy test and agreement to use effective contraception for 12 months after infusion
  • Ability to discontinue prohibited SLE medications per washout rules and willingness to comply with inpatient observation and long-term follow-up
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Active uncontrolled infection including active tuberculosis, hepatitis B or C with active replication, or HIV
  • Prior CAR-T therapy or prior CD19- or BCMA-directed cell therapy
  • Severe active CNS lupus requiring urgent escalation of immunosuppression, uncontrolled seizure disorder, or stroke within 60 days before screening
  • End-stage organ failure not expected to improve, such as dialysis-dependent kidney failure, uncontrolled advanced heart failure, or ICU-level respiratory instability
  • Active malignancy or history of malignancy within 5 years except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or other low-risk malignancy in durable remission
  • Pregnant or breastfeeding
  • History of allogeneic hematopoietic stem cell transplant or solid organ transplant
  • Contraindication to fludarabine, cyclophosphamide, leukapheresis, or standard rescue medications for cytokine release syndrome or ICANS
  • Live vaccine within 4 weeks before lymphodepletion
  • Participation in another interventional clinical study within 3 months before enrollment
  • Uncontrolled psychiatric disease, active substance misuse, or social circumstances impairing adherence
  • Any condition making participation unsafe or confounding study endpoint interpretation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China, 518036

Actively Recruiting

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Research Team

S

shan S Lu, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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