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Refractory Systemic Lupus ErythematosusEarly Phase 1NCT05930314

CNCT19 Cell Injection for Refractory Systemic Lupus Erythematosus

A Early Phase 1 study testing CNCT19 cell injection in people with Refractory Systemic Lupus Erythematosus and Lupus Nephritis, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Investigator-initiated, single-arm, open-label, single dose clinical study to evaluate the safety and preliminary efficacy of CNCT19 in treatment of patients with refractory systemic lupus erythematosus(SLE) presented with active lupus nephritis or active immune thrombocytopenia. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
CNCT19 cell 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
19 Jun 2023to 30 May 2025
Phase
Early Phase 1
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. Able to sign Informed Consent Form (ICF) ;
  • 2. Males or females 18-70（include 18 and 70） years of age;
  • 3. Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) 1997 or European League against Rheumatism(EULAR)/ the American College of Rheumatology (ACR) 2019 criteria .Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) 1997 or European League against Rheumatism(EULAR)/ the American College of Rheumatology (ACR) 2019 criteria .
  • Group1:Have active, biopsy-proven proliferative lupus nephritis Class III or IV, or Class V using the 2003 ISN/RPS criteria. The biopsy must be performed in the 6 months prior to the screening visit or during the screening period. Have documentation of active renal disease defined as:24h Proteinuria> 1.5 grams/day.
  • Refractory lupus nephritis is defined as no induced remission to treatment regimens containing at least one immunosuppressant (including glucocorticoids, CTX, tacrolimus, MMF, and cyclosporine) after 3 to 6 months, accompanied by no reduction (or worsening) of proteinuria or persistent antibody positives.
  • Group 2: Refractory thrombocytopenia: No response to treatment with at least 1 course of MP shock (1g for 3 days) or high dose of glucocorticoids (1mg/kgd equivalent dose of glucocorticoids) combined with 1 or more immunosuppressants. Before enrollment, at least 2 consecutive blood routine tests were performed to check platelets below 50×10^9/L and above 30×10^9/L. Other non-SLE causes of thrombocytopenia, such as infection, bone marrow suppression, and hypersplenism, were excluded.
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  • 4. Not pregnant or nursing.
  • 5. Adequate organ functions indicated as: ALT and AST < 3 times of the ULN； Total bilirubin < 2mg/dL with the exception of patients with Gibert-Meulengracht syndrome, who may be included if their total bilirubin is < 3 x ULN and direct bilirubin < 1.5mg/dL ULN； An estimated glomerular filtration rate < 30 mL/min/1.73 m^2 at the screening visit Serum creatinine ≤1.5mg/dl(133umol/l); Must have a minimum level of pulmonary reserve, non-oxygenated blood oxygen saturation >95%;
  • 6. Lymphocyte count > 0.4×10^9/L；
  • 7. Use a small dose of glucocorticoid (dose equivalent to ≤10mg/d prednisone) for not less than 1 month (except glucocorticoid intolerance).

Who cannot join

  • 1. Severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accidents;
  • 2. Dialysis patients or creatinine clearance rate < 30ml/min；
  • 3. Pregnant or breast feeding；
  • 4. Active infections (such as sepsis, bacteremia, fungemia, uncontrolled pulmonary infection, and active tuberculosis);
  • 5. One of the following: HBsAg positive HCV-Ab positive HIV positive TP positive
  • 6. Undergone major surgery assessed by the subjects as unsuitable for inclusion within 4 weeks prior to screening.
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  • 7. Had or is currently suffering from other malignant tumors within five years prior to screening, except for curable tumors with negligible risk of metastasis or death, such as cervical carcinoma in situ and skin basal cell carcinoma with adequate treatment;
  • 8. The heart meets any of the following conditions: Left ventricular ejection fraction (LVEF) ≤45%; New York Heart Association (NYHA) Class III or IV congestive heart failure or active heart disease; Severe arrhythmias requiring treatment (except atrial fibrillation and paroxysmal supraventricular tachycardia); QTcB interval male ≥450ms, female ≥470ms (QTcB=QT/RR^1/2); Had a myocardial infarction, bypass, or stent surgery within the 6 months prior to the study; Other heart diseases that the investigators judged unsuitable for inclusion;
  • 9. Received live vaccine within 6 weeks prior to screening；
  • 10. Participants who have participated in other interventional clinical studies within the 3 months prior to cell transfusion, received active investigational drug therapy, or who intend to participate in another clinical trial or receive treatment outside the protocol during the entire study period.
  • 11. a history of epilepsy or other active central nervous system diseases;
  • 12. Subjects who are known to have hypersensitivity to the ingredients of the preparation used in the test;
  • 13. Previously received CAR T cell therapy;
  • 14. Other conditions deemed unsuitable for participation in this clinical trial by subject.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xiaofeng Zeng

    Beijing

Other trials in China

About this study

Investigator-initiated, single-arm, open-label, single dose clinical study to evaluate the safety and preliminary efficacy of CNCT19 in treatment of patients with refractory systemic lupus erythematosus(SLE) presented with active lupus nephritis or active immune thrombocytopenia.

Being tested
CNCT19 cell injection
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Nephritis, Purpura, Thrombocytopenic, Idiopathic

What participants receive

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

  • CNCT19 cell injectionDrug

    Leukapheresis and manufacturing of CNCT19: enrolled subjects will undergo a leukapheresis to target a yield of > 1x 10^9 mononuclear cells

    • Lymphodepleting chemotherapy i. Fludarabine 25 to 30 mg/m2, once daily for 3 days ii. Cyclophosphamide 500 mg/m2, once daily for 3 days
    • CNCT19 administration i. 0.25 to 0.5 x 10^8 CAR-positive viable T cells
Study groups in NCT05930314
Study groupRoleWhat they receive
CNCT19 cell injetionExperimentalCNCT19 administration：0.25 to 0.5 x 10^8 CAR-positive viable
Receives: Drug: CNCT19 cell injection

What is being measured

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

  1. Adverse events

    Measured: 1 year

Timeline

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

  1. First posted5 Jul 2023
  2. Study start19 Jun 2023
  3. Primary completion30 May 2024 (estimated)
  4. Study completion30 May 2025 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
refractory systemic lupus erythematosus(SLE) presented with active lupus nephritis or active immune thrombocytopenia.
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05930314
Sponsor's protocol ID
HY001009
Status last verified
Jun 2023
First submitted
24 Jun 2023
Last updated
5 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li M, Zhao J, Lu ZJ, Ning C, Jiang N, Zhang Y, Li Y, Feng Y, Wang Q, Xu D, Leng X, Li J, Zhang S, Wang Z, Peng L, Tian X, Lv L, Zhou D, Zeng X. Anti-CD19 CAR T cell therapy for refractory SLE-ITP. Med. 2026 Apr 10;7(4):101039. doi: 10.1016/j.medj.2026.101039. Epub 2026 Mar 18.

    PubMed 41856114

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CNCT19 cell injection in people with Refractory Systemic Lupus Erythematosus and Lupus Nephritis, run by Peking Union Medical College 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 10 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: status not confirmed, as of the sponsor's last update on 5 Jul 2023. 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?

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?

Adverse events (time frame: 1 year). 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 NCT05930314, which also lists 1 linked publication.

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 5 Jul 2023.

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