RecruitingPhase 1NCT06037018

Safety Study of CC312 in Adult Patients With Relapsed/Refractory CD19 Positive B-cell Hematologic Malignancies

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


Sponsor

CytoCares Inc

Enrollment

44 participants

Start Date

Aug 7, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety of a new drug called CC312 in patients with certain blood cancers (B-cell cancers like B-cell lymphoma, leukemia, or chronic lymphocytic leukemia) that have returned or stopped responding to prior treatment. **You may be eligible if...** - You have a confirmed CD19-positive B-cell blood cancer (such as B-cell lymphoma, leukemia, or CLL) - Your cancer has relapsed (come back) or is no longer responding to standard treatments - You are in reasonably good health and your liver and kidney function are within acceptable ranges - Your life expectancy is more than 3 months **You may NOT be eligible if...** - Your liver or kidney function is significantly impaired - You have uncontrolled infections or serious other illnesses - You have active brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCC312

Doses from 0.3 to 45 µg/dose by intravenous infusion


Locations(1)

InstituteHBDH

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06037018


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