A Study of OL-CD19-GDT in Relapsed/ Refractory Autoimmune Diseases

NCT07167537 | Recruiting Phase 1 DMC

• 1 other identifier: OL-CD19-GDT-002
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-CD19-GDT in relapsed/refractory autoimmune diseases.

Conditions

Systemic Sclerosis (SSc); Primary Sjogren's Syndrome

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Adverse events will be assessed based on the CTCAE 5.0

  After OL-CD19-GDT administration up to 30 days (Day 1-Day 30)

• Treatment emergent adverse event (TEAE) incidence and severity

  Adverse events will be assessed based on the CTCAE 5.0

  From lymphodepletion through study completion, up to 2 years

Secondary Outcomes (7)

• Overall Response Rate

  Baseline through study completion, up to 2 years

• Cmax of OL-CD19-GDT

  Baseline through study completion, up to 2 years

• Tmax of OL-CD19-GDT

  Baseline through study completion, up to 2 years

• AUC 0-28 days

  Baseline through study completion, up to 2 years

• Serum cytokines

  From lymphodepletion till day 90

Study Arms (1)

OL-CD19-GDT

EXPERIMENTAL

Biological: OL-CD19-GDT

Interventions

OL-CD19-GDT BIOLOGICAL

OL-CD19-GDT will be given through IV bolus with ascending dose levels to determine the RDE and RP2D as specified in the protocol

OL-CD19-GDT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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., viral infections, opportunistic infections, including but not limited to severe cytomegalovirus or herpes virus infections)
• Congenital long QT syndrome or a corrected QTcF interval of ≥480 ms at screening (unless secondary to pacemaker or bundle branch block)
• Uncontrolled hypertension (blood pressure ≥160/100 mm Hg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes or other endocrine diseases, severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the patient's ability to tolerate the study treatment
• history of organ transplant
• Pregnancy or lactating women
• Use of any other experimental medication within 4 weeks or 5 half-lives prior to start of study drug
• Use of biologics within 10 weeks, stem cell transplant within 6 months prior to the start of study drug
• Prior CAR-T treatment
• Received live or attenuated vaccine within 4 weeks of Cycle 1 Day 1

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead
• Overland Therapeutics: collaborator

Study Sites (1)

Beijing GoBroad Hospital

Beijing, 102206, China

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Shaocong Miao

CONTACT

86+18831006667; miaosc@gobroadhealthcare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of Immunotherapy for Hematopoietic Malignancies

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 11, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)