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

ConditionsSystemic Lupus Erythematosus (SLE)Lupus Nephritis (LN)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-70
SponsoriCell Gene Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 16-70 years at the time of signing the informed consent

Have a diagnosis of SLE by EULAR/ACR 2019 criteria for ≥6 months.

Have at least one of an antinuclear antibody, anti-double-stranded deoxyribonucleic acid (dsDNA), or elevated anti-Smith (Sm) antibody

Inadequate response to 2 prior standard of care therapies, used for at least three months

Disqualifiers

Any acute, severe lupus related flare that needs immediate treatment

History of antiphospholipid syndrome with thromboembolic event within 12 months

History or current diagnosis of any disease, condition or treatment that may confound clinical assessments in the study.

Has drug-induced SLE.

Trial design

Design model

Single group

Treatments tested in this trial

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

    Biological/Vaccine

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Single armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Adverse Events after ICG318 infusion

Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESI), and Dose Limiting Toxicities (DLTs).

Time frame
Starting day 0 and up to 1 year after ICG318 infusion.
2

DORIS remission rate

DORIS remission defined as no circulating autoantibodies (e.g. dsDNA, Smith etc.) detected, no SLE medications, and SLEDAI-2K score of 0-1 (down from severe 7-10).

Time frame
Starting day 0 and assessed at 6 months, and 1 year after ICG318 infusion.

Secondary outcomes

1

Determine the recommended phase 2 dose (RP2D) regimen.

The protocol is based on cohort schema with dose escalation from 0.5x10\^6/kg to 4x10\^6/kg.

Time frame
Starting day 0 and assessed 1 year after ICG318 infusion.
2

Cmax

Maximum serum concentration of ICG318.

Time frame
Assessed as per schedule of events up to 1 year after ICG318 infusion.
3

Tmax

Time to maximum serum concentration of ICG318.

Time frame
Assessed as per schedule of events up to 1 year after ICG318 infusion.
4

T1/2

Half-life of ICG318 serum concentration.

Time frame
Assessed as per schedule of events up to 1 year after ICG318 infusion.

Other outcomes

Sponsors and contacts

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

iCell Gene Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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