BridgeMD
New treatment option for Idiopathic Inflammatory Myopathies(IIM)
Official title An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT07174843
What this study is testing
What is CD19/CD22/BCMA CAR-T cells(BZE2204)?
CD19/CD22/BCMA CAR-T cells(BZE2204) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for idiopathic inflammatory myopathies(iim).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability and preliminary efficacy of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA(BZE2204) in patients with relapsed or refractory active autoimmune diseases, including idiopathic inflammatory myopathies(IIM), immune thrombocytopenia(ITP), systemic lupus erythematosus(SLE).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Major
- Males or females, aged 18-70 years old
- Adequate bone marrow, hepatic, renal, coagulation and pulmonary function defined as:
- Bone marrow reservation: absolute neutrophil count (ANC) ≥1 ×10\^9/L; absolute lymphocyte count (ALC)≥ 0.5 ×10\^9/L; hemoglobulin ≥80 g/L; platelets...
- Hepatic function: i: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 upper limit of normal(ULN) (except for elevations are...
You likely can't join if
- A history of severe hypersensitivity or allergic reactions, or contraindications or hypersensitivity to any component of the investigational drug
- Presence of any serious heart diseases defined in the protocol
- A medical history of severe central nervous system or symptoms within 6 months
- Any concurrent malignancy or a history of malignancy with exceptions indicated in the protocol
- Clinically significant hemorrhage symptoms or definite bleeding tendencies (except for events caused by ITP) within 6 months prior to screening...
- Any positive results of contagious diseases as following:
See the full eligibility criteria
Who can join
- Major
- Males or females, aged 18-70 years old
- Adequate bone marrow, hepatic, renal, coagulation and pulmonary function defined as:
- Bone marrow reservation: absolute neutrophil count (ANC) ≥1 ×10\^9/L; absolute lymphocyte count (ALC)≥ 0.5 ×10\^9/L; hemoglobulin ≥80 g/L; platelets ≥50 ×10\^9/L(except for ITP);
- Hepatic function: i: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 upper limit of normal(ULN) (except for elevations are evaluated to be related to autoimmune disease by investigators)and ii...
- Renal function: serum creatinine ≤ 1.5 ULN , or estimated glomerular filtration rate(eGFR) ≥ 60 mL/min/1.73m2 [eGFR=186×age\^-0.203×SCr\^-1.154（mg/dl）,female×0.742]
- Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5 ULN
- Pulmonary function: Have the minimum level of pulmonary reserve, defined as ≤ CTCAE (Common Terminology Criteria for Adverse Events) grade 1 dyspnea and the SaO2(oxygen saturation)≥ 91% on room air
- Life expectancy \> 6 months
- people with relapsed or refractory active IIM also need meet following criteria:
- people with suspected or confirmed dermatomyositis(DM), polymyositis(PM), anti-synthetase syndrome(ASS) and immune-mediated necrotizing myopathy(IMNM, need to be assessed by the investigator that the patient has no...
- Positive (+ or above) for at least one myositis-specific antibody (MSA) or myositis-associated antibody (MAA), including anti-TIF-1γ, NXP-2, Mi-2α, Mi-2β, MDA-5, SAE-1/2, SRP, HMGCR, Jo-1, PL-7, PL-12, HA, EJ, OJ, KS...
- At screening, the subject must have moderate to severe IIM, defined as manual muscle testing (MMT) ≤ 141 and 2 of the following criteria are met; or CT suggests active interstitial lung disease(ILD)
- Physician global activity assessment (PGA) ≥ 2 cm (Visual analogue scale VAS 10 cm);
- Patient global activity assessment (PtGA) ≥ 2 cm ( VAS 10 cm scale);
- Extramuscular global assessment (Myositis Disease Activity Assessment Tool [MDAAT]) ≥ 2.0 cm (VAS 10 cm scale);
- Health assessment questionnaire (HAQ) \> 0.25;
- Elevation in one or more muscle enzymes (CK, LDH, AST, ALT) is ≥ 1.5 ULN;
- Lack of how well it works or intolerance to corticosteroids and at least 1 immunosuppressant or biologic agents
- people with relapsed or refractory active ITP also need meet following criteria
- Diagnosed with ITP for more than 3 months, including primary ITP and ITP secondary to autoimmune diseases
- Platelets \<50 ×10\^9/L with at least twice tests(≥24h interval)
- At least one platelet glycoprotein specific autoantibody positive
- Lack of how well it works for first line of therapy, or lack of how well it works/relapse post splenectomy
- people with relapsed or refractory active SLE also need meet following criteria
- Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria for at least 6 months
- Positive autoantibodies: antinuclear antibody (ANA) and/or anti-double strand-DNA(dsDNA) antibody and/or anti-Smith(Sm) antibody
- SLEDAI-2K scores ≥8 at screening. If the scores for low complement and/or anti-ds-DNA antibody are available, the SLEDAI-2K scores for clinical symptoms (except low complement and/or anti-ds-DNA antibody) should be ≥6
- Proliferative class III or IV , or class III+V or IV+V lupus nephritis(LN) confirmed by biopsies within 12 months; urine protein \> 1.0g/24h or urine protein creatinine ratio (UPCR) \>1000mg/g and PGA\>1
- Lack of how well it works or intolerance to at least one immunosuppressant and/or one biologic in medical history; for LN patients, relapse during maintenance post induction therapy is also eligible. Major
What rules you out
- A history of severe hypersensitivity or allergic reactions, or contraindications or hypersensitivity to any component of the investigational drug
- Presence of any serious heart diseases defined in the protocol
- A medical history of severe central nervous system or symptoms within 6 months
- Any concurrent malignancy or a history of malignancy with exceptions indicated in the protocol
- Clinically significant hemorrhage symptoms or definite bleeding tendencies (except for events caused by ITP) within 6 months prior to screening; arteriovenous thrombosis events within 6 months prior to screening
- Any positive results of contagious diseases as following:
- Human immunodeficiency virus (HIV) antibody positive;
- HBsAg positive; or HBcAb/HBeAb positive (people with HBV DNA copy numbers below the lower limit of detection can be enrolled);
- hepatitis C antibody (HCV-Ab) positive (the people with HCV RNA below the lower limit of detection can be enrolled) or a known medical history of hepatitis C;
- Treponema pallidum antibody (TP-Ab) positive
- Epstein-Barr virus(EBV), cytomegalovirus(CMV) antibody positive and copy number is above the limit
- Active tuberculosis or latent tuberculosis that has not been adequately treated
- Evidenced viral, bacterial or fungal infection that is uncontrolled or requires systemic antimicrobial therapy
- Requirements of wash-out period for specific treatment are not met(detailed in protocol)
- people with relapsed or refractory active IIM will be excluded in the following situations:
- Inclusion body myositis, amyopathic dermatomyositis or secondary myositis with documented medical history
- Severe muscle damage
- Uncontrolled extra muscle damage relating to PM or DM
- people with relapsed or refractory active ITP will be excluded if platelet \< 10x10\^9/L with active bleeding or bleeding score ≥5
- people with relapsed or refractory active SLE will be excluded if the subject has lupus crisis within 3 month, active CNS lupus, severe hemolytic anemia, severe thrombocytopenic purpura etc
- Any situations evaluated by investigators that may prevent the people from participating in the study, or may confound the study results, or participation in this study is not in the best interests of the people.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.