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

ConditionsREFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUSLupus Nephritis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Biotech

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age 18 to 70 years at consent. 2. Meets 2019 EULAR/ACR classification criteria for SLE, with total score >= 10.

Disqualifiers

1. Active uncontrolled infection, including active tuberculosis, hepatitis B or C with active replication, or HIV.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Autologous anti-CD19 CAR-T cells, intravenous single infusion at protocol-defined dose level (1 x 10^6 or 3 x 10^6 CAR-positive viable T cells/kg).

    Biological/Vaccine

    Autologous anti-CD19 CAR-T cells are patient-derived T lymphocytes that are genetically engineered to target CD19-expressing B cells. In clinical trials, a single intravenous infusion is administered at a protocol-defined dose (e.g., 1 × 10⁶ or 3 × 10⁶ CAR-positive viable T cells per kg) to evaluate safety, tolerability, and preliminary efficacy.

  • Fludarabine

    Drug

    30 mg/m2/day IV on Days -5 to -3.

  • Cyclophosphamide

    Drug

    300 mg/m2/day IV on Days -5 to -3.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: CD19-selectedExperimental treatment 3 interventions
Group B: BCMA-Selected CAR-TExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Dose-limiting toxicities (DLTs)

Incidence of protocol-defined DLTs, including product-related Grade 3 or higher non-hematologic toxicity and prolonged severe cytopenia.

Time frame
28 days
2

Incidence and severity of cytokine release syndrome (CRS)

Incidence and severity of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, graded by ASTCT criteria.

Time frame
28
3

Protocol-defined lupus response

Proportion of participants achieving DORIS remission without rescue therapy or, for those with active baseline LN, complete renal response without rescue therapy.

Time frame
24 weeks

Secondary outcomes

1

Complete renal response in LN subgroup

Renal response rate in participants with active lupus nephritis at baseline.

Time frame
52 weeks

Other outcomes

Sponsors and contacts

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

Beijing Biotech

Lead sponsor

Source ClinicalTrials.gov
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