Autoimmune DiseasesEarly Phase 1NCT06279923
CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases
A Early Phase 1 study testing CD19-BAFF Targeted CAR T-cells in people with Autoimmune Diseases, run by Zhejiang University at 1 site in China.
Trial summary
Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- CD19-BAFF Targeted CAR T-cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 1 Feb 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Gender unlimited，18<Age;
- 2. Diagnosed as Autoimmune Diseases（Systemic Lupus Erythematosus，Immune nephritis, Systemic sclerosis，Dermatomyositis，Neuromyelitis optica）and after routine treatment (using more than 2 types drugs, such as hormones and Immunosuppressants，Immunomodulator or Biological agents) are ineffective for more than 6 months or reappear with disease activity and/or no effective treatment after disease remission
- 3. Estimated life expectancy of minimum of 12 weeks;
- 4. The blood routine meets the following standards:
- Lymphocyte count>0.3×10e9/L;
- Neutrophils ≥0.5×10e9/L;
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- Hemoglobin ≥60g/L;
- Platelet ≥30×10e9/L
- 5. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
- 6.Those who voluntarily participated in this trial and provided informed consent;
Who cannot join
- 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
- 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- 3.Pregnant or lactating women (the safety of this therapy for unborn children is still unknown)
- 4. Patients with HIV infection
- 5. Active infection of hepatitis B virus or hepatitis C virus;
- 6. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
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- 7. Creatinine>176.8 umol/L, or ALT / AST > 3 times of normal amounts, or bilirubin>51 umol/L;
- 8. Any unsuitable to participate in this trial judged by the investigator;
- 9. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 3 months;
- 10. Received immunosuppressive therapy within one week prior to mononuclear cell collection；
- 11. ndividuals who have used systemic steroid drugs exceeding 20mg/d of prednisone or equivalent doses within one week prior to treatment (excluding those who have recently or are currently using inhaled steroids)；
- 12. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.
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, 1 recruiting
- Recruiting
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310000
He Huang, MD, 86-13605714822, hehuangyu@126.com
Yongxian Hu, MD, +8615957162012, huyongxian2000@aliyun.com
About this study
Official title: Clinical Study of Targeting CD19-BAFF CAR-T Cells in the Treatment of Autoimmune Diseases
Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases.
Read the detailed description
In this study, 45 patients with Autoimmune Diseases include Systemic Lupus Erythematosus、Systemic sclerosis、Dermatomyositis、Immune nephritis and Neuromyelitis optica were proposed to undergo CD19-BAFF CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19-BAFF CAR-T cell therapy for Autoimmune Diseases; At the same time, on the basis of expanding the sample size, more safety data on CD19-BAFF CAR-T cell treatment for Autoimmune Diseases were accumulated, including rare and delayed complications.
- Conditions
- Autoimmune Diseases
- Being tested
- CD19-BAFF Targeted CAR T-cells
- Keywords
- CD19-BAFF CAR-T
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-BAFF Targeted CAR T-cellsBiological
Also called CD19-BAFF Targeted CAR T-cells injection
Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Administration of CD19-BAFF Targeted CAR T-cells | Experimental | Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects. Receives: Biological: CD19-BAFF Targeted CAR T-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: Up to 28 years after Treatment
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Measured: Up to 2 years after Treatment
Secondary outcomes (3)
Multiple Myeloma (MM), Overall response rate (ORR)
Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR)
Measured: Up to 2 years after Treatment
Progression-free survival (PFS)
The time from randomization or start of study treatment until objective tumor progression or death
Measured: Up to 2 years after Treatment
Duration of remission,DOR
The time from CR/CRi and PR to disease relapsed or death due to disease
Measured: Up to 1 years after Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 Apr 2024 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (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 Zhejiang UniversityThe 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
- Investigators
- He Huang, MD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279923
- Sponsor's protocol ID
- TXB2023023
- Status last verified
- Apr 2024
- First submitted
- 19 Feb 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Targeting CD19-BAFF CAR-T Cells in the Treatment of Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT06279923
- Acronym / sponsor ID
- TXB2023023
- Conditions
- Autoimmune Diseases
- Keywords
- CD19-BAFF CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 28 Feb 2024 (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.
Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases.
Detailed description
In this study, 45 patients with Autoimmune Diseases include Systemic Lupus Erythematosus、Systemic sclerosis、Dermatomyositis、Immune nephritis and Neuromyelitis optica were proposed to undergo CD19-BAFF CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19-BAFF CAR-T cell therapy for Autoimmune Diseases; At the same time, on the basis of expanding the sample size, more safety data on CD19-BAFF CAR-T cell treatment for Autoimmune Diseases were accumulated, including rare and delayed complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of CD19-BAFF Targeted CAR T-cells | Experimental | Biological: CD19-BAFF Targeted CAR T-cellsDose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Gender unlimited，18<Age;
- 2. Diagnosed as Autoimmune Diseases（Systemic Lupus Erythematosus，Immune nephritis, Systemic sclerosis，Dermatomyositis，Neuromyelitis optica）and after routine treatment (using more than 2 types drugs, such as hormones and Immunosuppressants，Immunomodulator or Biological agents) are ineffective for more than 6 months or reappear with disease activity and/or no effective treatment after disease remission
- 3. Estimated life expectancy of minimum of 12 weeks;
- 4. The blood routine meets the following standards:
- 5. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
Key exclusion criteria (12 listed)
- 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
- 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- 3.Pregnant or lactating women (the safety of this therapy for unborn children is still unknown)
- 4. Patients with HIV infection
- 5. Active infection of hepatitis B virus or hepatitis C virus;
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 |
|---|---|---|
| CD19-BAFF Targeted CAR T-cellsAlso: CD19-BAFF Targeted CAR T-cells injectionEach subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion | Biological | Administration of CD19-BAFF Targeted CAR T-cells |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Up to 28 years after Treatment
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years after Treatment
Incidence of treatment-emergent adverse events [Safety and Tolerability]
3 secondary outcomes
Multiple Myeloma (MM), Overall response rate (ORR)
Time frame: Up to 2 years after Treatment
Progression-free survival (PFS)
Time frame: Up to 2 years after Treatment
Duration of remission,DOR
Time frame: Up to 1 years after Treatment
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 9 Apr 2024.
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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.
He Huang, MD principal investigator
Zhejiang University
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 CD19-BAFF Targeted CAR T-cells in people with Autoimmune Diseases, run by Zhejiang University 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 10 inclusion and 12 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 9 Apr 2024. 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 He Huang, MD (86-13605714822, hehuangyu@126.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: Up to 28 years after Treatment). 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?
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 9 Apr 2024.