Actively Recruiting
Safety Study of CC312 in Adult Patients With Relapsed/Refractory CD19 Positive B-cell Hematologic Malignancies
Led by CytoCares Inc · Updated on 2025-09-22
44
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1, open-label, dose-escalation study to evaluate the safety, PK, PD and immunogenicity of CC312 following intravenous doses of CC312 in patients with relapsed and refractory (r/r) CD19 expressing B-cell non-Hodgkin lymphoma and B-cell lymphocytic leukemia.
CONDITIONS
Official Title
Safety Study of CC312 in Adult Patients With Relapsed/Refractory CD19 Positive B-cell Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with relapsed or refractory CD19 positive B-cell malignancies including aggressive or indolent B-cell non-Hodgkin lymphoma, Philadelphia chromosome-positive or negative B-cell acute lymphoblastic leukemia, or B-cell chronic lymphocytic leukemia
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 with life expectancy greater than 3 months
- Laboratory values during screening: total bilirubin less than 1.5 times upper limit of normal (ULN), or up to 3 times ULN if due to liver metastases or Gilbert's Syndrome
- ALT or AST less than 3 times ULN, or up to 5 times ULN if due to liver metastases
- Creatinine clearance greater than 50 mL/min (Cockcroft-Gault formula)
- Hemoglobin 7 g/dL or higher
- Neutrophil count greater than 1,000/mm3 for B-cell NHL patients
- Platelet count greater than 75,000/mm3 for B-cell NHL patients
- Peripheral blast count 30,000/mm3 or less for B-ALL patients before first CC312 dose
- Prothrombin time-international normalized ratio (PT-INR) less than or equal to 1.5 times ULN
- Female patients of childbearing potential and male patients with partners of childbearing potential must use contraception during the study and for 3 months after last dose
- Ability to understand, provide written informed consent, and comply with scheduled visits and procedures
You will not qualify if you...
- Systemic anticancer therapy within 5 half-lives or participation in other clinical trials within 4 weeks before CC312 treatment
- Radiotherapy within 2 weeks before study entry
- CAR-T cell therapy within 3 months before study entry
- Active serious infection requiring antibiotics within 14 days before study entry
- Prior anti-CD19 therapy unless tumor cells still express CD19
- Brain metastases unless asymptomatic, stable, and steroid-free for 2 weeks before CC312 dose
- Corticosteroids above 10 mg prednisone or equivalent daily or immunosuppressive medication within 7 days before first dose, except certain topical or inhaled steroids
- Live virus vaccination within 4 weeks prior to enrollment
- Active or history of autoimmune disease with potential central nervous system involvement
- Known allergy to protein drugs or CC312 components
- Unresolved toxic effects from prior therapy above Grade 1
- Evidence of illicit drug use, drug abuse, or alcohol abuse
- Recent serious cardiovascular events within 6 months or uncontrolled arrhythmias
- Recent major or minor surgery with incomplete healing
- Certain cardiac conditions including long QT syndrome, low ejection fraction, significant arrhythmias
- Poorly controlled diabetes or hypertension
- Other serious medical, psychiatric, or geographical conditions interfering with study participation
- Concurrent malignancy within 5 years except certain treated cancers
- Pregnant or nursing women
- Active hepatitis B or C infection
- Known HIV infection
- Recent stem cell or bone marrow transplantation within defined timeframes
- Investigator judgment of unsuitability for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
InstituteHBDH
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
Z
ZHEN JING, MM
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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