A Study to Test CRT-402 in Refractory Autoimmune Disease
19. august 2026 opdateret af: Myeloid Therapeutics
A Phase 1/2 Dose Escalation and Expansion Study of CRT-402, an In Vivo CD19 Targeted CAR-T Therapy, in Refractory Autoimmune Disease
Patients with refractory autoimmune diseases often have limited treatment options and ongoing disease activity despite standard therapies.
CRT-402 is an in vivo Cluster of differentiation 19 (CD19)-targeted CAR-T cell therapy designed to deplete CD19-positive B cells and promote immune system reset.
This study evaluates the safety, tolerability, preliminary efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of CRT-402 in participants with active refractory systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM).
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Detaljeret beskrivelse
This is a multicenter, open-label, Phase 1/2, first-in-human, dose escalation and expansion study designed to assess the safety and tolerability, as well as define the recommended Phase 2 dose (RP2D) of CRT-402 in participants with refractory autoimmune disease.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
34
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Clinical Department
- Telefonnummer: +1 617 465 1022
- E-mail: CRT402-clinical@createmedicines.com
Studiesteder
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Western Australia
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Nedlands, Western Australia, Australien, 6009
- Linear Advanced Clinical Trial Centre, Ground Floor, B Block, Queen Elizabeth II Medical Centre, Hospital Avenue
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Kontakt:
- Prof. Merrilee Needham
- Telefonnummer: +61 8 6382 5100
- E-mail: actcstartup@linear.org.au
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Ledende efterforsker:
- Merrilee Needham
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Age 18 years or older.
- Diagnosis of active, refractory systemic lupus erythematosus, systemic sclerosis, or idiopathic inflammatory myopathy meeting established classification criteria, with inadequate response or intolerance to standard therapy.
- Adequate renal, hepatic, cardiac, and pulmonary function per protocol-defined criteria.
- Participants of reproductive potential must agree to use protocol-specified contraception during the study and for a defined period after dosing.
- Females of childbearing potential must have a negative pregnancy test before treatment.
- Must be willing and able to attend study visits and follow all study requirements.
Exclusion Criteria:
- Clinical suitability for a less burdensome and/or approved therapeutic approach, as judged by the Investigator,
- Any medical condition or laboratory abnormality that, in the Investigator's judgment, would place the participant at unacceptable risk or confound interpretation of study data,
- Prior Cluster of differentiation 19 (CD19)-directed, cell, or gene therapy,
- History of bone marrow/ hematopoietic stem cell or solid organ transplantation,
- Active or inadequately treated infection, including Human immunodeficiency (HIV), hepatitis B or C, or tuberculosis,
- Pregnancy or lactation.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: CRT-402
Participants will receive CRT-402 by intravenous infusion.
Dose escalation will proceed according to protocol-defined safety criteria.
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CRT-402 administered by intravenous infusion.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and dose-limiting toxicities (DLTs).
Tidsramme: Up to 52 weeks
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Adverse events (AEs) are any new or worsening medical problems that occur after starting the study treatment.
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Up to 52 weeks
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Incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Tidsramme: Up to 52 weeks
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cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome ICANS will be graded using standard consensus criteria.
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Up to 52 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Assess emergence of anti-drug antibodies (ADAs)
Tidsramme: Up to 52 weeks
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Serum for anti-drug antibody analysis will be collected at designated visits indicated in the Schedule of Assessments (SOA).
Samples will be collected using standard site practices.
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Up to 52 weeks
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Pharmacokinetic parameter: Maximum observed plasma concentration (Cmax)
Tidsramme: Day 1 through Day 22
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Day 1 through Day 22
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Pharmacokinetic parameter: Area under the curve (AUC)
Tidsramme: Day 1 through Day 22
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Day 1 through Day 22
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Pharmacokinetic parameter: Time to Maximum Concentration (tmax)
Tidsramme: Day 1 through Day 22
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Day 1 through Day 22
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Pharmacokinetic parameter: Plasma clearance (CL)
Tidsramme: Day 1 through Day 22
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Day 1 through Day 22
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Pharmacokinetic parameter: Volume of distribution (Vd)
Tidsramme: Day 1 through Day 22
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Day 1 through Day 22
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Pharmacokinetic parameter: Mean Residence Time (MRT)
Tidsramme: Day 1 through Day 22
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Day 1 through Day 22
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Pharmacokinetic parameter: Apparent terminal half-life (t1/2)
Tidsramme: Day 1 through Day 22
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Day 1 through Day 22
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Pharmacokinetic parameter: Terminal elimination rate constant (λz).
Tidsramme: Day 1 through Day 22
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Day 1 through Day 22
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Overall Response Rate (ORR), measured by disease-specific composite response criteria.
Tidsramme: Week 24
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Week 24
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Adam Raff, MD, PhD, SVP Clinical Development, CREATE Medicines
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
24. august 2026
Primær færdiggørelse (Anslået)
1. december 2028
Studieafslutning (Anslået)
1. august 2029
Datoer for studieregistrering
Først indsendt
6. august 2026
Først indsendt, der opfyldte QC-kriterier
19. august 2026
Først opslået (Faktiske)
21. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CRT-402-01
Plan for individuelle deltagerdata (IPD)
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