Actively Recruiting
Safety Study of CC312 in Autoimmune Disease Patients
Led by CytoCares Inc · Updated on 2025-09-17
18
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune diseases. The trial also assesses pharmacokinetics (PK) and preliminary efficacy. CC312 is a trispecific T cell engager (TriTE) that targets the B cell surface antigen CD19, the T cell antigen CD3, and the T cell co-stimulatory molecule CD28. Given its mechanism of action, which is similar to the "biopharmaceutical version" of CAR-T, there is a higher risk of cytokine release syndrome (CRS) at the onset of infusion administration. Therefore, a lower priming dose will be administered before the therapeutic dosing phase to mitigate this risk and ensure safety, followed by a therapeutic dose to achieve and maintain efficacy. The study is divided into three dose groups, with 3-6 subjects enrolled in each group, resulting in a total of 9-18 subjects in the study. A "3+3" dose escalation design is employed to systematically evaluate the safety and determine the optimal dose of CC312.
CONDITIONS
Official Title
Safety Study of CC312 in Autoimmune Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent, male or female
- Able to understand study details and provide informed consent
- Diagnosed with one of the following autoimmune diseases meeting specified criteria: SLE, IIM, SSc, RA, ITP, or AIHA
- Stable or specified prior treatments for at least 4 to 12 weeks depending on disease
- Laboratory values within defined limits for blood counts, liver and kidney function
- Left ventricular ejection fraction of 50% or higher
- Agree to use effective contraception during study and for 6 months after last dose if of reproductive potential
You will not qualify if you...
- Severe lupus nephritis or need for prohibited treatments within 8 weeks before screening
- Central nervous system diseases related or unrelated to SLE within 8 weeks before screening
- Other specified muscle diseases or severe muscle injury unrelated to IIM
- Pulmonary hypertension or severe gastrointestinal involvement related to SSc
- History of significant organ transplantation or hematopoietic stem cell transplant
- Multiple immune diseases requiring systemic treatment deemed unsuitable
- IgA deficiency (serum level <10 mg/dL)
- Participation in another clinical trial or certain treatments within specified timeframes before screening
- Prior CAR-T therapy within 6 months
- Known allergies to monoclonal antibodies or CC312 components
- History of substance abuse or illicit drug use
- Recent major or minor surgery with unhealed wounds
- Serious cardiovascular diseases or events within 6 months before screening
- Other serious medical, mental, or psychological conditions judged unsuitable
- Recent or concurrent malignant tumors except certain localized cancers
- Positive viral serology for HIV, hepatitis B or C, or syphilis
- Active or latent tuberculosis
- Recent splenectomy within 6 months
- Specific exclusion criteria related to ITP and AIHA regarding bleeding, medications, and coagulation abnormalities
- Pregnant or breastfeeding women
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China, China, 300030
Actively Recruiting
Research Team
C
CEO
CONTACT
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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