Autoimmune DiseasesEarly Phase 1NCT07613411
Safety and Efficacy of KSVCBD Injection in Autoimmune Diseases
A Early Phase 1 study testing KSVCBD injection in people with Autoimmune Diseases, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This single-arm, open-label, early exploratory clinical study is designed to evaluate the safety and preliminary efficacy of KSVCBD injection in patients with Autoimmune Diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- KSVCBD injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Mar 2029
- Phase
- Early 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
- Age 18-65 years (inclusive), any gender.
- Subjects diagnosed with the following autoimmune disease: moderate/severe refractory Systemic Lupus Erythematosus, elapsed/refractory Systemic Sclerosis, relapsed/refractory ANCA-Associated Vasculitis, refractory Idiopathic Inflammatory Myopathy, active Sjögren's Syndrome, chronic/refractory Immune Thrombocytopenia, refractory Antiphospholipid Syndrome, relapsed/refractory pemphigus, relapsed/refractory IgG4-Related Disease.
- Having adequate organ function as required by the protocol.:
- Voluntarily adhere to the contraception requirements as specified in the protocol.
- Willing to comply with all study procedures and voluntarily participate in this study and sign the informed consent form (ICF).
Who cannot join
- Previous or current active malignancy, including patients with cancer-associated polymyositis/dermatomyositis. Exceptions are cured or relapse-free for at least 3 years: cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer, locally advanced prostate cancer after radical treatment, or ductal carcinoma in situ after radical surgery.
- Severe pulmonary disease within the past 1 year, such as moderate/severe pulmonary arterial hypertension (pulmonary artery systolic pressure >50 mmHg on echocardiography), requirement for oxygen therapy via reservoir mask or non-invasive/invasive ventilator support at screening.
- Use of any of the protocol specified drugs or treatments within the specified timeframes.
- History or current symptoms of severe central nervous system (CNS) disease within the past 6 months.
- Known severe allergy to the study drug or any of its components.
- Presence of uncontrolled fungal, bacterial, or viral infection, or other infections considered by the investigator to make the subject unsuitable for participation.
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- History of major organ transplant or hematopoietic stem cell/bone marrow transplantation.
- History of other autoimmune diseases requiring systemic treatment, other than the target indication.
- History of non-IIM conditions such as drug induced myopathy, HIV associated myopathy, thyroid myopathy, or family history of myopathy.
- Pregnant or breastfeeding women.
- Use of any live vaccines within 6 weeks before enrollment.
- Participation in another interventional clinical study and receipt of an active investigational drug within 3 months prior to signing the ICF, or intention to participate in another clinical trial or receive treatment for autoimmune diseases outside the protocol during the entire study period.
- Psychiatric disorders with depression or suicidal tendencies.
- Any other factors considered by the investigator to make the subject unsuitable for enrollment or to affect the subject's participation or completion of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jian Zhu, Ph.D., +86-010-55499314, jian_jzhu@126.com
About this study
Official title: A Clinical Study to Evaluate the Safety and Efficacy of KSVCBD Injection in Patients With Autoimmune Diseases
KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This single-arm, open-label, early exploratory clinical study is designed to evaluate the safety and preliminary efficacy of KSVCBD injection in patients with Autoimmune Diseases.
Read the detailed description
KSVCBD-R102 is an open-label study in subjects with autoimmune diseases and will be conducted in two stages: dose escalation (Stage A) and dose expansion (Stage B). In Stage A, a total of three dose levels explored. At the recommended dose established during the dose-escalation phase, subjects will be enrolled in a dose-expansion study to further evaluate the safety and preliminary efficacy of KSVCBD injection in subjects with autoimmune diseases. The dose-expansion study will explore two separate cohorts, each enrolling subject with an indication for which preliminary efficacy data have been obtained during the dose-escalation phase.
- Conditions
- Autoimmune Diseases
- Being tested
- KSVCBD injection
- Keywords
- Autoimmune Diseases, Immunotherapy
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSVCBD injectionDrug
KSVCBD injection is an in vivo CAR-T therapy targeting CD19/BCMA and is administered by IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Autoimmune Diseases | Experimental | Not described Receives: Drug: KSVCBD injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limited toxicity (DLT)
DLT is defined as any of the following adverse events (AEs) related to KSVCBD infusion occurring within 28 days after KSVCBD infusion (CRS and ICANS will be graded according to the ASTCT 2019 criteria, and other AEs will be evaluated using CTCAE v6.0).
Measured: Within 28 days post-infusion
Adverse events (AEs) and serious adverse events (SAEs)
Incidence and severity of AEs and SAEs
Measured: Within 24 months post-infusion
Adverse events of special interest (AESI)
Incidence and severity of AESIs.AESI including grade ≥3 Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and infections.
Measured: Within 24 months post-infusion.
Recommended Phase 2 Dose (RP2D)
Measured: Within 24 months post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhu, Chinese PLA General Hospital
- Investigators
- Jian Zhu, Principal investigator, Rheumatology Department of Chinese PLA General HospitalWeidong Han, Principal investigator, Biotherapeutic Department of Chinese PLA General HospitalYang Liu, Principal investigator, Biotherapeutic Department of Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613411
- Sponsor's protocol ID
- KSVCBD-R102
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 29 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Efficacy of KSVCBD Injection in Patients With Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07613411
- Acronym / sponsor ID
- KSVCBD-R102
- Conditions
- Autoimmune Diseases
- Keywords
- Autoimmune Diseases, Immunotherapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 29 May 2026 (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.
KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This single-arm, open-label, early exploratory clinical study is designed to evaluate the safety and preliminary efficacy of KSVCBD injection in patients with Autoimmune Diseases.
Detailed description
KSVCBD-R102 is an open-label study in subjects with autoimmune diseases and will be conducted in two stages: dose escalation (Stage A) and dose expansion (Stage B). In Stage A, a total of three dose levels explored. At the recommended dose established during the dose-escalation phase, subjects will be enrolled in a dose-expansion study to further evaluate the safety and preliminary efficacy of KSVCBD injection in subjects with autoimmune diseases. The dose-expansion study will explore two separate cohorts, each enrolling subject with an indication for which preliminary efficacy data have been obtained during the dose-escalation phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autoimmune Diseases | Experimental | Drug: KSVCBD injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years (inclusive), any gender.
- Subjects diagnosed with the following autoimmune disease: moderate/severe refractory Systemic Lupus Erythematosus, elapsed/refractory Systemic Sclerosis, relapsed/refractory ANCA-Associated Vasculitis, refractory Idiopathic Inflammatory Myopathy, active Sjögren's Syndrome, chronic/refractory Immune Thrombocytopenia, refractory Antiphospholipid Syndrome, relapsed/refractory pemphigus, relapsed/refractory IgG4-Related Disease.
- Having adequate organ function as required by the protocol.:
- Voluntarily adhere to the contraception requirements as specified in the protocol.
- Willing to comply with all study procedures and voluntarily participate in this study and sign the informed consent form (ICF).
Key exclusion criteria (14 listed)
- Previous or current active malignancy, including patients with cancer-associated polymyositis/dermatomyositis. Exceptions are cured or relapse-free for at least 3 years: cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer, locally advanced prostate cancer after radical treatment, or ductal carcinoma in situ after radical surgery.
- Severe pulmonary disease within the past 1 year, such as moderate/severe pulmonary arterial hypertension (pulmonary artery systolic pressure >50 mmHg on echocardiography), requirement for oxygen therapy via reservoir mask or non-invasive/invasive ventilator support at screening.
- Use of any of the protocol specified drugs or treatments within the specified timeframes.
- History or current symptoms of severe central nervous system (CNS) disease within the past 6 months.
- Known severe allergy to the study drug or any of its components.
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 |
|---|---|---|
| KSVCBD injectionKSVCBD injection is an in vivo CAR-T therapy targeting CD19/BCMA and is administered by IV infusion. | Drug | Autoimmune Diseases |
Primary outcome
Dose limited toxicity (DLT)
Time frame: Within 28 days post-infusion
DLT is defined as any of the following adverse events (AEs) related to KSVCBD infusion occurring within 28 days after KSVCBD infusion (CRS and ICANS will be graded according to the ASTCT 2019 criteria, and other AEs will be evaluated using CTCAE v6.0).
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: Within 24 months post-infusion
Incidence and severity of AEs and SAEs
Adverse events of special interest (AESI)
Time frame: Within 24 months post-infusion.
Incidence and severity of AESIs.AESI including grade ≥3 Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and infections.
Recommended Phase 2 Dose (RP2D)
Time frame: Within 24 months post-infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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.
Jian Zhu principal investigator
Rheumatology Department of Chinese PLA General Hospital
Weidong Han principal investigator
Biotherapeutic Department of Chinese PLA General Hospital
Yang Liu principal investigator
Biotherapeutic Department of Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing KSVCBD injection in people with Autoimmune Diseases, run by Chinese PLA General 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 5 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: opening soon, as of the sponsor's last update on 29 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Jian Zhu, M.D. (+86-010-55499314, jian_jzhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limited toxicity (DLT) (time frame: Within 28 days post-infusion). The study lists 4 primary outcomes in all. 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 29 May 2026.