A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis

Part of paid clinical trials in Chicago, Illinois.

Sponsor
iCell Gene Therapeutics
Study ID
NCT07328581
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
16 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion — BIOLOGICAL
    Anti-BCMA, Anti-CD19 Compound CAR-T Cells

Study Details

This Phase IIa, open-label, single-arm study includes an initial Safety Run-In followed by dose expansion to evaluate the safety, tolerability, cellular kinetics, pharmacodynamics, and preliminary clinical activity of a single infusion of ICG318 in participants with refractory SLE, with or without LN. Participants will receive protocol-specified lymphodepletion followed by ICG318 at the recommended Phase 2 dose.

Key Dates

First listed
Jan 9, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm
    Biologic drug infusion

Primary Outcome Measure

Number of Adverse Events after ICG318 infusion [ Time Frame: Starting day 0 and up to 1 year after ICG318 infusion. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637
Melissa Tesher, MD
[email protected]
615-693-0748
New York Medical CollegeHawthorneNew York10532
Allyson Flowers, MD
[email protected]
914-614-4270
NorthWellNew Hyde ParkNew York11040
Jonathan Fish, MD
[email protected]
718-470-3460
Fox Chase Cancer Center- Temple BMTPhiladelphiaPennsylvania19111
Rashmi Khanal, MD
[email protected]
215-707-7464

Find similar trials in Chicago, IL

By research site
University of Chicago· Chicago, ILNew York Medical College· Hawthorne, NYNorthWell· New Hyde Park, NYFox Chase Cancer Center- Temple BMT· Philadelphia, PA

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