BCMA-CD19 cCAR T Cell Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (SLE)

NCT05474885 | Unknown Phase 1

• 1 other identifier: ICG180-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR T cells in patients with relapsed and/or refractory SLE.

Conditions

Relapsed/Refractory, Systemic Lupus Erythematosus (SLE)

Keywords

BCMA-CA19 CAR; lupus; SLE; systemic lupus erythematosus; autoimmune disorders

Outcome Measures

Primary Outcomes (1)

• The number and incidence of adverse events after BCMA-CD19 cCAR T cell infusion

  Evaluation all possible adverse reactions, including the number, incidence, and severity of symptoms such as cytokine release syndromes and neurotoxicity within 3 months after CAR infusion.

  3 months after CAR infusion

Secondary Outcomes (5)

• Autoantibody detection

  6 months after CAR infusion

• SLEAI score

  2 years after CAR infusion

• Renal functions

  1 year after CAR infusion

• Disease control

  2 years after CAR infusion

• Overall survival

  2 years after CAR infusion

Study Arms (1)

BCMA-CD19 cCAR T cells

EXPERIMENTAL

Dose escalation phase: patient's T cells will be transduced with a lentiviral vector to express a BCMA-CD19 cCAR. with an escalation approach.

Biological: BCMA-CD19 cCAR T cells

Interventions

BCMA-CD19 cCAR T cells BIOLOGICAL

BCMA-CD19 cCAR T cells are used to treat patients. Patient will be administered either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.

BCMA-CD19 cCAR T cells

Eligibility Criteria

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

You may qualify if:

• Age: 18\~65 years old;
• Expected survival period ≥ 3 months;
• Serum creatinine \<221.0μmol/L (2.5mg/dl);
• AST/ALT below 3 times the upper limit of normal, blood bilirubin \<34.2 μmol/L (2.0 mg/dl);
• Cardiopulmonary function is basically normal, echocardiography indicates that the ejection fraction is \>50%, and the oxygen saturation is above 94% in the resting state without oxygen;
• No obvious active infection;
• Physical fitness score 0\~2 points (ECOG standard);
• There are suitable veins for blood cell apheresis or whole blood collection, and there are no contraindications for blood collection;
• Since the effect of CAR T cell therapy on the fetus is unknown, women of childbearing age should have a negative serum or urine pregnancy test 48 hours before CAR T cell reinfusion, and agree to take effective measures during the trial until the last follow-up. contraceptive measures;
• Voluntary participation and informed consent signed by the patient or his/her legal/authorized representative.

You may not qualify if:

• Severe systemic lupus erythematosus: BILAG score at least 1 system is A and (or) \>2 systems reach B, or SELENA SLEDAI\>12 points.
• CNS disease: Active central nervous system (CNS) lupus (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident \[CVA\], encephalitis or CNS vasculitis), visual Disorders, cranial neuropathy requiring intervention
• Abnormal liver function: aspartate transaminase (AST) or alanine transaminase (ALT) or glutamyl transpeptidase (GGT) detection value is greater than 3 times the upper limit of normal (ULN); or alkaline phosphatase ( ALP) or total bilirubin test value greater than 1.5 times the upper limit of normal (ULN);
• Kidney disease: hemodialysis or high-dose glucocorticoid treatment is required within 90 days before visit 2, such as prednisone (or equivalent dose of glucocorticoid) ≥ 100 mg/d, or creatinine (Cr) or blood urea nitrogen (BUN) detection value greater than 1.5 times the upper limit of normal (ULN), or eGFR ≤ 60ml/min before visit 2. eGFR is calculated using the MDRD formula: eGFR (ml/min×1.73m\^2)=186×serum creatinine (Scr)-1.154×age-0.203× (multiply by 0.724 if the subject is a female)
• Cardiovascular disease: history of acute myocardial infarction, or unstable angina pectoris, severe arrhythmia (multi-source frequent premature ventricular tachycardia, ventricular tachycardia, ventricular fibrillation) in the past 6 months; New York heart function class (NYHA) class III- Level IV
• Other uncontrolled diseases: acute or chronic diseases (such as acute pneumonia, pulmonary hypertension, diabetic ketoacidosis, acute pancreatitis, etc.) that are clinically unstable or have not been effectively controlled and are not related to SLE. judgments that may confound study results or place subjects at undue risk.
• Infection: Subject has acute or chronic infection requiring treatment (eg, tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria)
• Surgery or other conditions: planning to undergo surgery or have any other medical history (eg, recent history of sepsis), abnormal laboratory tests, or other conditions, judged by the investigator to be inappropriate to participate in this study
• Biologics therapy: Received any drug therapy (antibody, inhibitor or agonist) targeting T, B lymphocytes, cytokines or receptors within two months
• Participated in any clinical study within 3 months prior to enrollment
• The use of contraindicated drugs or therapies may affect the judgment of the efficacy of CART: 1) Received any of the following treatments within 90 days before Visit 2: (1) Intravenous immune globulin (IVIG); (2) Oral high-dose glucocorticoids Hormones, such as prednisone \>100mg/d; (3) plasma exchange, leukotomy; 2) new immunosuppressive/immune modulators were added within 60 days before visit 2, and the disease is still under control.
• Received live vaccine treatment within 30 days prior to Visit 2
• Transplantation: History of vital organ transplantation (eg, heart, lung, kidney, liver) or hematopoietic stem cell/or bone marrow transplantation
• HIV positive.
• Active hepatitis B or C.

Sponsors & Collaborators

• iCell Gene Therapeutics: lead
• iCAR Bio Therapeutics Ltd. China: collaborator

Study Sites (1)

Zhongshan People's Hospital

Zhongshan, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Lupus Erythematosus, Systemic; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Central Study Contacts

Kevin Pinz

CONTACT

6315386218; kevin.pinz@icellgene.com

Wei-Jia Wang, MD

CONTACT

011-86-13715679657; wangwj@zsph.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2022
• First Posted: July 26, 2022
• Study Start: April 1, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: July 26, 2022

Record last verified: 2022-04

Locations

CN (1)