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BCMA-CD19 cCAR T for the Treatment of Refractory Lupus

NCT07328581 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-09

No results posted yet for this study

Summary

This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19-IL-15/IL15sushi cCAR T cells in patients with relapsed and/or refractory SLE, with or without Lupus Nephritis.

Conditions

  • Systemic Lupus Erythematosus (SLE)
  • Lupus Nephritis (LN)

Interventions

BIOLOGICAL

ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following cyclophosphamide-only lymphodepletion

Anti-BCMA, Anti-CD19 Compound CAR-T Cells

Sponsors & Collaborators

  • iCell Gene Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07328581 on ClinicalTrials.gov