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Systemic Sclerosis (SSc)Phase 1NCT07167537

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

A Phase 1 study testing OL-CD19-GDT in people with Systemic Sclerosis (SSc) and Primary Sjogren's Syndrome, run by Beijing GoBroad Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
What is being tested?
OL-CD19-GDT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
Oct 2025to Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 18Show fewer
  • 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
  • Presence of other autoimmune or auto-inflammatory diseases that may affect study assessments, such as rheumatoid arthritis, gout, or active fibromyalgia syndrome.
  • Limited to patients diagnosed with SSc: at risk for scleroderma renal crisis; SSc-associated gastric antral vascular ectasia; Severe gastrointestinal involvement leading to malabsorption or intestinal failure
  • Limited to patients diagnosed with pSS: primary biliary cholangitis

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shaocong Miao contact

86+18831006667

miaosc@gobroadhealthcare.com

China1 site, 1 recruiting

  • Beijing GoBroad Hospital

    Beijing, 102206

    Recruiting

Other trials in China

About this study

Official title: An Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Allogeneic CAR-T Cell Therapy (OL-CD19-GDT) in the Treatment of Relapsed/Refractory Autoimmune Diseases

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

Read the detailed description

This is an open-label, single-arm, clinical study to evaluate the efficacy and safety of CAR-T therapy OL-CD19-GDT in the treatment of Relapsed/ Refractory Autoimmune Diseases such as SSc and pSS.

Being tested
OL-CD19-GDT
Medical subject headings
Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OL-CD19-GDTBiological

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

Study groups in NCT07167537
Study groupRoleWhat they receive
OL-CD19-GDTExperimentalNot described
Receives: Biological: OL-CD19-GDT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT)

    Adverse events will be assessed based on the CTCAE 5.0

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

  2. Treatment emergent adverse event (TEAE) incidence and severity

    Adverse events will be assessed based on the CTCAE 5.0

    Measured: From lymphodepletion through study completion, up to 2 years

Secondary outcomes (7)

  1. Overall Response Rate

    The efficacy outcome variable, Overall Response Rate (ORR), is defined as the ratio between the number of subjects experiencing a response at weeks 12, 24 and 52 and the total number of enrolled subjects. A response to treatment will be considered as:*SSc: Fulfillment of mCRISS criteria *pSS: Achieving ESSDAI response

    Measured: Baseline through study completion, up to 2 years

  2. Cmax of OL-CD19-GDT

    The maximum concentration of the CAR-T cells will be measured to assess OL-CD19-GDT in vivo expansion and persistence.

    Measured: Baseline through study completion, up to 2 years

  3. Tmax of OL-CD19-GDT

    The time of the maximum concentration will be measured to assess OL-CD19-GDT in vivo expansion and persistence.

    Measured: Baseline through study completion, up to 2 years

  4. AUC 0-28 days

    Area under the curve will be measured to assess OL-CD19-GDT in vivo expansion and persistence.

    Measured: Baseline through study completion, up to 2 years

  5. Serum cytokines

    The levels of cytokines will be measured, such as IL-6.

    Measured: From lymphodepletion till day 90

  6. Level of Immunogenicity

    To assess the presence of antibodies to OL-CD19-GDT (ADA)

    Measured: Baseline through study completion, up to 2 years

  7. Level of RCR

    To determine whether Replication Competent Retrovirus (RCR) is present in patients that receive OL-CD19-GDT

    Measured: Baseline through study completion, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2025
  2. Study startOct 2025 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07167537
Sponsor's protocol ID
OL-CD19-GDT-002
Status last verified
Aug 2025
First submitted
10 Sep 2025
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OL-CD19-GDT in people with Systemic Sclerosis (SSc) and Primary Sjogren's Syndrome, run by Beijing GoBroad Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shaocong Miao (86+18831006667, miaosc@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: After OL-CD19-GDT administration up to 30 days (Day 1-Day 30)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07167537.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.

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