Healthcare Utilization and Costs of Systemic Lupus Erythematosus by Disease Severity in the United States.
Irene B Murimi-Worstell, Dora H Lin, Hong Kan...
https://pubmed.ncbi.nlm.nih.gov/32611669Actively Recruiting
Early Phase 1
Age: 18Years +
All Genders
ID06888960
An Exploratory Clinical Study on the Safety of CC312 in Treating Patients With Refractory Autoimmune Diseases
Led by CytoCares Inc · Updated on 2025-09-17
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of CC312, a trispecific T cell engager targeting CD19, CD3, and CD28, in adult patients with relapsed and refractory autoimmune diseases. This early-phase, open-label trial aims to assess pharmacokinetics and preliminary effectiveness while carefully managing risks like cytokine release syndrome through a priming dose followed by therapeutic doses. The study uses a "3+3" dose escalation design across three dose groups involving 9 to 18 participants. After a 28-day screening period, eligible participants receive CC312 intravenously starting with a guided priming dose on Day -3, followed by safety assessments on Day -1. Therapeutic doses are then administered on Days 1, 4, 8, 11, 15, 18, 22, and 25, with ongoing safety and tolerability evaluations at each infusion. This design helps identify the optimal dose while monitoring for adverse effects. Participants undergo baseline assessments and biological sample collection before dosing. Throughout the study, safety data including dose-limiting toxicities and adverse events are tracked for up to two years. Additional measures include pharmacokinetic analyses, immune cell counts, disease activity scores, and advanced cellular analyses. Female and male participants of reproductive potential must agree to contraception and reproductive restrictions during and after treatment. The total study duration includes screening, guided dose, therapeutic dosing, and long-term safety monitoring.
CONDITIONS
Brief Title
Safety Study of CC312 in Autoimmune Disease Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Understand the study and voluntarily sign the consent form
- Age 18 years or older, any gender
- Diagnosed with one of the following: systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM), systemic sclerosis (SSc), rheumatoid arthritis (RA), primary immune thrombocytopenia (ITP), or autoimmune hemolytic anemia (AIHA) according to specific diagnostic criteria
- Meet disease activity and antibody criteria as detailed for each condition
- Stable on specified standard treatments for minimum durations before first dose
- Laboratory values within required ranges for blood counts, liver and kidney functions
- Left ventricular ejection fraction of 50% or higher
- Agree to use effective contraception during the study and for 6 months after last dose if of reproductive potential
You will not qualify if you...
- Severe lupus nephritis or active nephritis requiring prohibited treatments
- Central nervous system diseases caused by or unrelated to SLE within 8 weeks before screening
- Other types of IIM or severe muscle injury unrelated to IIM
- Pulmonary arterial hypertension or rapidly progressive gastrointestinal involvement related to SSc
- Significant organ transplants or history of bone marrow or stem cell transplants
- More than one immune disease requiring systemic treatment if judged unsuitable
- IgA deficiency
- Participation in other clinical trials or CAR-T therapy within specified timeframes
- Recent treatments with B-cell depleting drugs or non-standard anti-SLE therapies
- Recent live or attenuated vaccine use
- Active infection or history of severe allergic reactions to monoclonal antibodies or CC312 components
- Substance abuse or alcoholism
- Recent major or minor surgeries with unhealed wounds
- Recent serious cardiovascular diseases
- Other serious underlying diseases or mental illnesses affecting compliance
- Recent or active malignant tumors except certain treated cancers
- Pregnant or breastfeeding women
- Positive viral serology for HIV, hepatitis B or C, or syphilis
- Active or latent tuberculosis
- Recent splenectomy
- Specific exclusions related to ITP and AIHA including coagulation abnormalities
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 28 days
Participants receive intravenous infusions of CC312, starting with a guided dose followed by multiple therapeutic doses with safety and tolerability assessments at each infusion.
9 visits (in-person) for infusions and assessments
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China, China, 300030
Actively Recruiting
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Research Team
C
CEO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Systemic lupus erythematosus: epidemiology, pathophysiology, manifestations, and management.
Giulio Fortuna, Michael T Brennan
https://pubmed.ncbi.nlm.nih.gov/24034070Recent insights in the epidemiology of autoimmune diseases: improved prevalence estimates and understanding of clustering of diseases.
Glinda S Cooper, Milele L K Bynum, Emily C Somers
https://pubmed.ncbi.nlm.nih.gov/19819109