A Study of OL-CD19-GDT in Relapsed/ Refractory Autoimmune Diseases (NCT07167537) | Clinical Trial Compass
RecruitingPhase 1
A Study of OL-CD19-GDT in Relapsed/ Refractory Autoimmune Diseases
China44 participantsStarted 2025-10
Plain-language summary
This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-CD19-GDT in relapsed/refractory autoimmune diseases.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Adults aged 18-65 years old
* ECOG 0-2
* Adequate organ function
* Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and must agree to use a highly effective contraceptive method starting from the time of lymphodepletion and for 2 years after dosing of the IMP
* SSc specific:
a)Fulfilling the 2013 ACR/EULAR classification criteria of SSc; b) mRSS score \>10; c) at least one vital organ involvement besides the skin; d)relapsed or refractory to at least one immunosuppressant or biologic.
* pSS specfic: a)Fulling the 2016 EULAR/ACR classification critieria for pSS; b) anti-Ro/anti-SSA antibody positive; c) ESSDAI score ≥5 ; d)relapsed or refractory to at least one immunosuppressant or biologic.
Exclusion Criteria:
* Active uncontrolled infection
* Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load
* Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
* HIV antibody positive
* Syphilis antibody positive
* Active tuberculosis, untreated or inadequately treated latent tuberculosis infection (LTBI)
* History of serious infection within 3 months prior to screening (defined as requiring hospitalization or intravenous antimicrobial therapy), or history of oral antimicrobial therapy within 1 month prior to screening (e.g.,…
What they're measuring
1
Dose-limiting toxicity (DLT)
Timeframe: After OL-CD19-GDT administration up to 30 days (Day 1-Day 30)
2
Treatment emergent adverse event (TEAE) incidence and severity
Timeframe: From lymphodepletion through study completion, up to 2 years