CNCT19 Cell Injection for Refractory Systemic Lupus Erythematosus

NCT05930314 | Unknown Early Phase 1

• 1 other identifier: HY001009
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractory Systemic Lupus Erythematosus; Lupus Nephritis; Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Adverse events

  1 year

Study Arms (1)

CNCT19 cell injetion

EXPERIMENTAL

CNCT19 administration：0.25 to 0.5 x 10\^8 CAR-positive viable

Drug: CNCT19 cell injection

Interventions

CNCT19 cell injection DRUG

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

CNCT19 cell injetion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Able to sign Informed Consent Form (ICF) ;
• \. Males or females 18-70（include 18 and 70） years of age;
• \. 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.
• \. Not pregnant or nursing.
• \. 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%;
• \. Lymphocyte count \> 0.4×10\^9/L；
• \. Use a small dose of glucocorticoid (dose equivalent to ≤10mg/d prednisone) for not less than 1 month (except glucocorticoid intolerance).

You may not qualify if:

• \. Severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accidents;
• \. Dialysis patients or creatinine clearance rate \< 30ml/min；
• \. Pregnant or breast feeding；
• \. Active infections (such as sepsis, bacteremia, fungemia, uncontrolled pulmonary infection, and active tuberculosis);
• \. One of the following: HBsAg positive HCV-Ab positive HIV positive TP positive
• \. 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;
• \. Received live vaccine within 6 weeks prior to screening；
• \. 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.
• \. a history of epilepsy or other active central nervous system diseases;
• \. Subjects who are known to have hypersensitivity to the ingredients of the preparation used in the test;
• \. Previously received CAR T cell therapy;
• \. Other conditions deemed unsuitable for participation in this clinical trial by subject.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Xiaofeng Zeng

Beijing, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis; Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Xiaofeng Zeng, Dr

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Daobin Zhou, Dr

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: refractory systemic lupus erythematosus(SLE) presented with active lupus nephritis or active immune thrombocytopenia.

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 5, 2023
• Study Start: June 19, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2025
• Last Updated: July 5, 2023

Record last verified: 2023-06

Locations

CN (1)