Safety Study of CC312 in Adult Patients With Relapsed/Refractory CD19 Positive B-cell Hematologic Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCytoCares Inc
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
Systemic anticancer therapy within 5 half-lives of the agent or attending clinical trials 4 weeks prior to beginning CC312;
Treatment with radiotherapy within 2 weeks before the study entry;
Treatment with CAR-T within 3 months before the study entry;
Active serious infection requiring antibiotics within 14 days before study entry;
Trial design
Treatments tested in this trial
- CC312
Treatment groups
44 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov