Connective Tissue DiseasesNCT07152223
Clinical Study on the Safety and Efficacy of CD19-BCMA CAR-T Cell Therapy for Connective Tissue Diseases
A study testing CAR-T in people with Connective Tissue Diseases, run by Guangzhou Bio-gene Technology Co., Ltd at 1 site in China.
Trial summary
This study is a single-arm, single-center Investigator-Initiated Trial (IIT) designed to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of CD19-BCMA CAR-T cells in subjects diagnosed with connective tissue diseases. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Connective Tissue Diseases
- What is being tested?
- CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2025to 2 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Good compliance: The patient or their guardian understands and voluntarily signs the informed consent form, and it is expected that all documents, procedures, follow-up examinations and treatments stipulated in the study can be completed.
- Previously diagnosed with one of the following diseases and meeting the corresponding latest international classification/diagnostic criteria :
- Systemic lupus erythematosus (SLE);
- Rheumatoid arthritis (RA);
- Systemic scleroderma (SSc) ;
- Sjogren's Syndrome (SS);
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- Polymyositis/dermatomyositis (PM/DM);
- Mixed connective tissue disease (MCTD).
- Researchers determine that the disease is in an active stage;
- At least one autoantibody is positive in the serum or plasma during the screening period;
- Insufficient response, intolerance or recurrence to at least one standard treatment;
- The pregnancy test of the female subjects was negative, and the subjects agreed to take effective contraceptive measures throughout the trial period.
- The patient's major tissues and organs are functioning well.
Who cannot join
- Intracranial hypertension or confusion;
- Symptomatic heart failure or severe arrhythmia;
- Respiratory failure;
- Accompanied by other types of malignant tumors;
- Diffuse vascular coagulation;
- Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value;
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- Sepsis or other difficult-to-control infections;
- Uncontrollable diabetes;
- Severe mental disorder;
- Cranial magnetic resonance imaging (MRI) examination revealed obvious lesions in the intracranial cavity.
- WHO physical status classification ≥ level 3;
- Organ transplant recipients;
- Pregnant and lactating women;
- HIV+，HBV，HCV，EBV，CMV.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Clinical Study to Evaluate the Safety and Efficacy of CD19-BCMA CAR-T Cell Therapy for Connective Tissue Diseases
This study is a single-arm, single-center Investigator-Initiated Trial (IIT) designed to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of CD19-BCMA CAR-T cells in subjects diagnosed with connective tissue diseases.
- Conditions
- Connective Tissue Diseases
- Being tested
- CAR-T
- Keywords
- Connective Tissue Diseases
- Medical subject headings
- Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-TBiological
Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T | Experimental | The dosage range of 1.0 × 10^6/kg (± 20%) to 3.0 × 10^6/kg (± 20%) of CAR-T cells, administered intravenously. Receives: Biological: CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Safety
Count the Incidence of adverse events
Measured: Up to 2 years after CAR-T infusion
Secondary outcomes (3)
Effectiveness evaluation
The response rate of the responder index of systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic sclerosis (scleroderma SSc), Sjogren's Syndrome, polymyositis/dermatomyositis, and mixed connective tissue disease (MCTD), as well as the changes in scores compared with the baseline value
Measured: Up to 2 years after CAR-T infusion
Pharmacokinetic parameters
The highest concentration of CAR-T cell expansion in peripheral blood after administration.
Measured: Up to 2 years after CAR-T infusion
Pharmacodynamic parameters
The peak values of CAR-T-related cytokines, which include at least IL-6 and IFN-γ.
Measured: Up to 2 years after CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start7 Aug 2025
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Why it stopped: Due to corporate strategic adjustment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connective Tissue DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Bio-gene Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuelin He, Ph.D. degree, Principal investigator, Dongguan Taixin HospitalLan He, Ph.D. degree, Principal investigator, Dongguan Taixin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152223
- Sponsor's protocol ID
- CF-25-003
- Status last verified
- May 2026
- First submitted
- 26 Aug 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Clinical Study to Evaluate the Safety and Efficacy of CD19-BCMA CAR-T Cell Therapy for Connective Tissue Diseases
- ClinicalTrials.gov ID
- NCT07152223
- Acronym / sponsor ID
- CF-25-003
- Conditions
- Connective Tissue Diseases
- Keywords
- Connective Tissue Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to corporate strategic adjustment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guangzhou Bio-gene Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm, single-center Investigator-Initiated Trial (IIT) designed to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of CD19-BCMA CAR-T cells in subjects diagnosed with connective tissue diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T | Experimental | Biological: CAR-TThe dosage range of 1.0 × 10^6/kg (± 20%) to 3.0 × 10^6/kg (± 20%) of CAR-T cells, administered intravenously. |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Good compliance: The patient or their guardian understands and voluntarily signs the informed consent form, and it is expected that all documents, procedures, follow-up examinations and treatments stipulated in the study can be completed.
- Previously diagnosed with one of the following diseases and meeting the corresponding latest international classification/diagnostic criteria :
- Researchers determine that the disease is in an active stage;
- At least one autoantibody is positive in the serum or plasma during the screening period;
- Insufficient response, intolerance or recurrence to at least one standard treatment;
Key exclusion criteria (14 listed)
- Intracranial hypertension or confusion;
- Symptomatic heart failure or severe arrhythmia;
- Respiratory failure;
- Accompanied by other types of malignant tumors;
- Diffuse vascular coagulation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAR-TEligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy. | Biological | CAR-T |
Primary outcome
Evaluation of Safety
Time frame: Up to 2 years after CAR-T infusion
Count the Incidence of adverse events
3 secondary outcomes
Effectiveness evaluation
Time frame: Up to 2 years after CAR-T infusion
Pharmacokinetic parameters
Time frame: Up to 2 years after CAR-T infusion
Pharmacodynamic parameters
Time frame: Up to 2 years after CAR-T infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuelin He, Ph.D. degree principal investigator
Dongguan Taixin Hospital
Lan He, Ph.D. degree principal investigator
Dongguan Taixin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAR-T in people with Connective Tissue Diseases, run by Guangzhou Bio-gene Technology Co., Ltd 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 13 inclusion and 14 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: withdrawn, as of the sponsor's last update on 28 May 2026. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Safety (time frame: Up to 2 years after CAR-T infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.