Actively Recruiting
A Phase 1 Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Effects of CC312 in Adults With Relapsed/Refractory CD19 Positive B-cell Hematologic Malignancies
Led by CytoCares Inc · Updated on 2025-09-22
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immune response to CC312, a biological therapy given by intravenous infusion, in adults with relapsed or refractory CD19-positive B-cell hematologic cancers including non-Hodgkin lymphoma and B-cell lymphocytic leukemia. This Phase 1 open-label study aims to find the best dose levels and understand how the drug behaves in the body and its potential anti-tumor effects. The study has two parts. Part 1 uses an accelerated dose-escalation design where patients receive escalating doses of CC312 through a priming dose, an intermediate dose, and then twice-weekly doses for three weeks. Part 2-A continues dose escalation with more patients to confirm the maximum tolerated dose or recommended Phase 2 dose, followed by Part 2-B where additional patients receive treatment at these doses. The doses range from 0.3 to 45 micrograms given intravenously. Participants will have scheduled visits including blood tests to measure drug levels, immune markers, and side effects during treatment cycles lasting 28 days. Researchers will carefully monitor for dose-limiting toxicities and adverse events up to 28 days after treatment. The study includes assessments before and during treatment to understand the body's response and safety profile. Total participation length depends on individual treatment and follow-up schedules.
CONDITIONS
Brief 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...
- Confirmed diagnosis of 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 with relapse or refractory status
- ECOG performance status of 0 to 2 and life expectancy longer than 3 months
- Clinical lab values within specified limits including bilirubin, liver enzymes, creatinine clearance, hemoglobin, neutrophil and platelet counts, and coagulation tests
- 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 and provide written informed consent and comply with study visits and procedures
You will not qualify if you...
- Receipt of systemic anticancer therapy within 5 half-lives or participation in other clinical trials within 4 weeks prior to CC312 treatment
- Radiotherapy within 2 weeks before study entry
- CAR-T therapy within 3 months before study entry
- Active serious infection requiring antibiotics within 14 days before study entry
- Prior anti-CD19 therapy unless tumor still expresses CD19
- Brain metastases or neurological conditions except stable asymptomatic brain metastases without steroid need for 2 weeks
- Use of corticosteroids or immunosuppressants within 7 days prior to first dose, with some exceptions
- Live virus vaccination within 4 weeks prior to enrollment
- Current or history of autoimmune disease involving the central nervous system
- Allergy to protein drugs or CC312 formulation components
- Unresolved toxic effects from prior therapy above grade 1
- Drug or alcohol abuse
- Recent major or minor surgery without full healing
- Certain cardiac, metabolic, or other serious medical conditions as judged by investigator
- 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 transplant as specified
- Investigator judgment of unsuitability for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days including dose limiting toxicity observation
Participants receive intravenous doses of CC312 starting with a priming dose and an intermediate dose in the first week, followed by escalated twice weekly doses for three weeks. Dose levels and schedules vary based on study part and individual dosing cohorts.
Multiple visits during the 4-week treatment cycle including dosing and assessments
Duration - 28 days following the end of treatment
Participants are monitored for safety, adverse events, pharmacokinetics, and pharmacodynamics after treatment completion.
Visits for safety and laboratory assessments during the 28-day follow-up period
Trial Site Locations
Total: 1 location
1
InstituteHBDH
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
Z
ZHEN JING, MM
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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