A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Efficacy of CC312 in Adult Patients With Relapsed/Refractory CD19 Positive B-cell Hematologic Malignancies

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• CD19 positive B-cell malignancies confirmed as one of the following: aggressive or indolent B-cell NHL, philadelphia chromosome-positive or -negative B-cell ALL, or B-cell CLL; patient must meet the definition of relapse/refractory before enrollment.

• ECOG (Eastern Cooperative Oncology Group) performance status 0-2, life expectancy \>3 months;

• Clinical laboratory values as specified below during the Screening period.

‣ Total bilirubin \<1.5 ULN, may be elevated up to 3 x ULN if the elevation can be reasonably ascribed to the presence of metastatic disease in the liver or in patients with documented Gilbert's Syndrome;

⁃ ALT or AST \<3ULN, may be elevated up to 5 x ULN if the elevation can be reasonably ascribed to the presence of metastatic disease in liver;

⁃ Calculated creatinine clearance \> 50 mL/min (The Cockcroft-Gault formula);

⁃ Hemoglobin ≥ 7 g/dL;

⁃ Neutrophil count \> 1,000/mm3 for B-cell NHL patient;

⁃ Platelet count \> 75,000/mm3 for B-cell NHL patient;

⁃ B-ALL patients must have peripheral blast count ≤ 30,000/ mm3 prior to first dose of CC312.

⁃ Prothrombin time-international normalized ratio (PT-INR) ≤ 1.5ULN.

• Female patients of childbearing potential or male patients with a partner of childbearing potential must use one or more contraception methods from screening and continued during study treatment until 3 months after the last dose;

• Ability to understand and willingness to provide written informed consent and to comply with scheduled visits and study procedures.

Locations
Other Locations
China
InstituteHBDH
RECRUITING
Tianjin
Contact Information
Primary
ZHEN JING, MM
zhen.jing@cytocares.com
86-21-50582090
Time Frame
Start Date: 2023-08-07
Estimated Completion Date: 2026-03
Participants
Target number of participants: 44
Treatments
Experimental: CC312
Sponsors
Leads: CytoCares Inc

This content was sourced from clinicaltrials.gov

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