SafetyNCT06310811
Anti-CD19 CAR-T Cell Therapy in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
A study testing RD06-04 Cells injection in people with Safety and Effective, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is an open, Phase I, investigator-initiated study (IIT) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with moderate or severe active SLE. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- RD06-04 Cells injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2024to 1 Mar 2027
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.The subjects voluntarily participated in the experiment and signed the informed consent.
- 2. Age ≥18 years old and ≤70 years old, regardless of gender. 3. Diagnosis of SLE according to the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria 2019 or the 2012 International Clinical Collaboration Group on Systemic Erythraeus (SLICC) criteria.
- 4. Prior to screening, patients must have been treated with glucocorticoids combined with immunosuppressants and/or biologics for at least 2 months, and the dose is stable for >2 weeks, and the disease is still active (i.e., previous treatment with glucocorticoids + immunosuppressants or glucocorticoids + immunosuppressants + biologics, and any of the above drugs are not eligible for single drug use). Oral corticosteroids must meet the following requirements: 1) Prednisone (or equivalent) ≥7.5mg/ day; 2) There is no minimum daily dose requirement for corticosteroids when used in combination with immunosuppressants and/or biologics.
- 5. Screening is positive for antinuclear antibody (ANA), and/or anti-DS-DNA antibody, and/or anti-Smith antibody.
- 6. The SLEDAI-2K score in the screening period was >6, and the "clinical" SLEDAI-2K score was ≥4.
- Note: "Clinical" SLEDAI-2K is a score in the SLEDAI-2K score that does not include results attributable to any urine or laboratory tests (including immunological indicators) :
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- 7. The BILAG2004 score meets at least one of the following conditions:
- ≥1 organ system BILAG2004 Class A disease b) ≥2 organ systems BILAG2004 Class B disease 8. Physician General assessment (PGA) score ≥1.0 (0-3 on visual analogue scale VAS) during screening.
- 9. Organ function and laboratory tests:
- Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST≤3× upper normal limit (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert syndrome).
- Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml/min.
- Blood routine: neutrophil count ≥1×109/L, hemoglobin ≥60g/L, platelet count ≥20×109/L, lymphocyte count >0.3×109/L.
- Coagulation function: International standardized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN.
- Blood oxygen saturation (SpO2) at rest in indoor air ≥92%.
- Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%. 10. The serum or urine pregnancy test results of fertile female subjects at the time of screening were negative.
- 11. Fertile women must consent to the use of highly effective contraceptive methods for contraception from at least 28 days before the start of the infusion until 12 months after the RD06-04 reinfusion. Fertile men must consent to the use of an effective barrier method of contraception from the start of DTP until 12 months after RD06-04 reinfusion, and should not donate semen or sperm throughout the trial period.
Who cannot join
- 1. Combined with other autoimmune diseases, systemic treatment is required. 2. The presence of uncontrolled lupus crises within 8 weeks prior to screening, including acute lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulophilia, severe heart damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, was assessed by the investigators as not suitable for participation in this study.
- 3. Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, cerebral organ syndrome, or psychosis.
- 4. Have a history of allogeneic bone marrow or stem cell transplantation or solid organ transplantation (such as kidney, lung, heart, liver) or plan to undergo such transplantation in the future.
- 5. Clinically significant cardiovascular dysfunction in the 12 months prior to screening, including but not limited to: Class III or IV heart failure as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, or any ventricular arrhythmias.
- 6. A history of malignant neoplasm within 5 years prior to signing the ICF, with the exception of sufficiently treated or surgically resected non-melanoma skin cancer or carcinoma in situ (e.g. cervical, bladder, breast) with no residual disease.
- 7. Pregnant or lactating women. 8. A history of recurrent infections requiring hospitalization and intravenous antibiotics (e.g., 3 or more infections of the same type in the past year).
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- 9. There are active infections, such as infectious pneumonia and tuberculosis, that need systematic treatment within 2 weeks before the treatment.
- 10. Hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA test positive; Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive.
- 11. Have received live attenuated vaccine within 4 weeks prior to treatment or plan to receive live attenuated vaccine during the course of the study.
- 12. Receiving high doses of corticosteroids (prednisone ≥60 mg/ day or equivalent) within 4 weeks prior to drenching, or failing to taper prednisone to ≤10 mg/ day 5 days prior to drenching.
- 13. As indicated in Table 3, tapering or elution of background therapy is not possible prior to eluvial chemotherapy.
- 14. Were receiving renal replacement therapy in the 3 months prior to screening or expected to require renal replacement therapy during the study period.
- 15. History of drug or alcohol abuse within 1 year prior to screening. 16. History or evidence of suicidal thoughts in the 6 months prior to screening, or any suicidal behavior in the 12 months prior to screening, is considered by the investigator to be a significant risk of suicide.
- 17. Use of other study drugs within 4 weeks or 5 half-lives (whichever is older) prior to screening.
- 18. A history of hypersensitivity or life-threatening reactions to any ingredient or preparation of an investigational drug or investigational treatment, including chemotherapy. For more information about the ingredients of the investigational drug, see the Investigator's Manual (IB).
- 19. Any situation that the investigator believes may affect study participation, pose a safety risk to patients, or may confuse the interpretation of study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety, Efficacy, and Pharmacokinetics Study of Anti-CD19 CAR-T Cell Therapy in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
This is an open, Phase I, investigator-initiated study (IIT) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with moderate or severe active SLE.
This study will explore the safety of escalating doses of RD06-04 by presetting two dose levels (DL), with 3 to 6 patients enrolled in each dose level. After safety conclusions are reached in each group, the investigator can select the corresponding dose group to expand cases based on treatment response, but the total number of cases will not exceed 12.
Read more
This study will enroll patients in a 3+3 design with two DLS: 1×105 CAR+T cells /kg for DL1 and 5×105 CAR+T cells /kg for DL2.
Dose increment Refer to the 3+3 dose increment principle. Three subjects are expected to be enrolled in each dose group.
- Dose increment should start from the minimum dose, and it is not possible to conduct an incremental study of 2 or more dose groups at the same time.
- If 1 case of DLT occurs in each dose group, the dose level will be extended to 6 subjects. If 6 subjects at this dose level ≥2 subjects develop DLT, the dose level exceeds the MTD. The previous lower dose level will be extended to 6 subjects, and if 6 subjects have already been enrolled in the previous lower dose level, and only ≤1 of these 6 subjects develop DLT, this lower dose level will be considered MTD.
- If DLT occurred in ≥2 subjects in the highest dose group, the researcher could select a dose between the high dose group and the medium dose group according to the specific situation and perform MTD evaluation.
- If the dose increase to the highest dose group still does not reach DLT, researchers can explore the safety and efficacy of higher doses according to specific circumstances.
Case expansion:
After the completion of DLT evaluation in all dose groups, the investigators could select the corresponding dose group of extended cases according to the treatment response, but the total number of cases should not exceed 12 (extended cases were not evaluated by DLT).
- Being tested
- RD06-04 Cells injection
- Keywords
- CD19 CART, SLE
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD06-04 Cells injectionDrug
Patient will be treated with RD06-04 cells when enrolled in the study
| Study group | Role | What they receive |
|---|---|---|
| Cell injection | Experimental | Not described Receives: Drug: RD06-04 Cells injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT)
Measured: 28 days from cell infusion
The incidence of treatment-based adverse events (TEAEs) and the incidence of serious adverse events (SAEs).
Measured: 3 months from cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start7 Mar 2024
- Primary completion3 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Why it stopped: R\&D strategy adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will be treated with RD06-04 cell injections in a single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MEI HENG, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310811
- Sponsor's protocol ID
- BHCT-RD06-04-01
- Status last verified
- Jan 2026
- First submitted
- 4 Mar 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Efficacy, and Pharmacokinetics Study of Anti-CD19 CAR-T Cell Therapy in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06310811
- Acronym / sponsor ID
- BHCT-RD06-04-01
- Keywords
- CD19 CART, SLE
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: R\&D strategy adjustment
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 3 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 15 Mar 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.
This is an open, Phase I, investigator-initiated study (IIT) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with moderate or severe active SLE.
This study will explore the safety of escalating doses of RD06-04 by presetting two dose levels (DL), with 3 to 6 patients enrolled in each dose level. After safety conclusions are reached in each group, the investigator can select the corresponding dose group to expand cases based on treatment response, but the total number of cases will not exceed 12.
This study will enroll patients in a 3+3 design with two DLS: 1×105 CAR+T cells /kg for DL1 and 5×105 CAR+T cells /kg for DL2.
Dose increment Refer to the 3+3 dose increment principle. Three subjects are expected to be enrolled in each dose group.
- Dose increment should start from the minimum dose, and it is not possible to conduct an incremental study of 2 or more dose groups at the same time.
- If 1 case of DLT occurs in each dose group, the dose level will be extended to 6 subjects. If 6 subjects at this dose level ≥2 subjects develop DLT, the dose level exceeds the MTD. The previous lower dose level will be extended to 6 subjects, and if 6 subjects have already been enrolled in the previous lower dose level, and only ≤1 of these 6 subjects develop DLT, this lower dose level will be considered MTD.
- If DLT occurred in ≥2 subjects in the highest dose group, the researcher could select a dose between the high dose group and the medium dose group according to the specific situation and perform MTD evaluation.
- If the dose increase to the highest dose group still does not reach DLT, researchers can explore the safety and efficacy of higher doses according to specific circumstances.
Case expansion:
After the completion of DLT evaluation in all dose groups, the investigators could select the corresponding dose group of extended cases according to the treatment response, but the total number of cases should not exceed 12 (extended cases were not evaluated by DLT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will be treated with RD06-04 cell injections in a single group
| Arm | Type | Receives |
|---|---|---|
| Cell injection | Experimental | Drug: RD06-04 Cells injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1.The subjects voluntarily participated in the experiment and signed the informed consent.
- 2. Age ≥18 years old and ≤70 years old, regardless of gender. 3. Diagnosis of SLE according to the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria 2019 or the 2012 International Clinical Collaboration Group on Systemic Erythraeus (SLICC) criteria.
- 4. Prior to screening, patients must have been treated with glucocorticoids combined with immunosuppressants and/or biologics for at least 2 months, and the dose is stable for >2 weeks, and the disease is still active (i.e., previous treatment with glucocorticoids + immunosuppressants or glucocorticoids + immunosuppressants + biologics, and any of the above drugs are not eligible for single drug use). Oral corticosteroids must meet the following requirements: 1) Prednisone (or equivalent) ≥7.5mg/ day; 2) There is no minimum daily dose requirement for corticosteroids when used in combination with immunosuppressants and/or biologics.
- 5. Screening is positive for antinuclear antibody (ANA), and/or anti-DS-DNA antibody, and/or anti-Smith antibody.
- 6. The SLEDAI-2K score in the screening period was >6, and the "clinical" SLEDAI-2K score was ≥4.
Key exclusion criteria (16 listed)
- 3. Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, cerebral organ syndrome, or psychosis.
- 4. Have a history of allogeneic bone marrow or stem cell transplantation or solid organ transplantation (such as kidney, lung, heart, liver) or plan to undergo such transplantation in the future.
- 5. Clinically significant cardiovascular dysfunction in the 12 months prior to screening, including but not limited to: Class III or IV heart failure as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, or any ventricular arrhythmias.
- 6. A history of malignant neoplasm within 5 years prior to signing the ICF, with the exception of sufficiently treated or surgically resected non-melanoma skin cancer or carcinoma in situ (e.g. cervical, bladder, breast) with no residual disease.
- 7. Pregnant or lactating women. 8. A history of recurrent infections requiring hospitalization and intravenous antibiotics (e.g., 3 or more infections of the same type in the past year).
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 |
|---|---|---|
| RD06-04 Cells injectionPatient will be treated with RD06-04 cells when enrolled in the study | Drug | Cell injection |
Primary outcome
Incidence of dose-limiting toxicity (DLT)
Time frame: 28 days from cell infusion
The incidence of treatment-based adverse events (TEAEs) and the incidence of serious adverse events (SAEs).
Time frame: 3 months from cell infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RD06-04 Cells injection in people with Safety and Effective, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 16 inclusion and 16 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: paused, as of the sponsor's last update on 3 Feb 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?
Results are not available in the source record.
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?
Incidence of dose-limiting toxicity (DLT) (time frame: 28 days from cell infusion). 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 3 Feb 2026.