OncoMatch/Clinical Trials/NCT06037018
Safety Study of CC312 in Adult Patients With Relapsed/Refractory CD19 Positive B-cell Hematologic Malignancies
Is NCT06037018 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies CC312 for non-hodgkin lymphoma.
Treatment: CC312 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: CD19 positive
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic anticancer therapy — relapsed/refractory
patient must meet the definition of relapse/refractory before enrollment
Cannot have received: systemic anticancer therapy
Exception: within 5 half-lives of the agent or attending clinical trials 4 weeks prior to beginning CC312
Systemic anticancer therapy within 5 half-lives of the agent or attending clinical trials 4 weeks prior to beginning CC312
Cannot have received: radiotherapy
Exception: within 2 weeks before the study entry
Treatment with radiotherapy within 2 weeks before the study entry
Cannot have received: CAR-T cell therapy
Exception: within 3 months before the study entry
Treatment with CAR-T within 3 months before the study entry
Cannot have received: anti-CD19 directed therapy
Exception: eligible only if tumor cells have been shown to express CD19 after completing the CD19-directed therapy
Patients with prior treatment with anti-CD19 directed therapies are eligible only if their tumor cells have been shown to express CD19 after completing the CD19-directed therapy
Cannot have received: autologous stem cell transplant
Exception: B-NHL patient that received autologous stem cell transplant 6 months prior to study screening
B-NHL patient that received autologous stem cell transplant 6 months prior to study screening
Cannot have received: organ or allogeneic stem cell/bone marrow transplant
Exception: historically received organ or allogeneic stem cell/bone marrow transplant
historically received organ or allogeneic stem cell/bone marrow transplant
Cannot have received: transplantation treatment
Exception: B-ALL patients that received transplantation treatment within 3 months prior to enrollment
B-ALL patients that received transplantation treatment within 3 months prior to enrollment in the study
Lab requirements
Blood counts
Hemoglobin ≥ 7 g/dL; Neutrophil count > 1,000/mm3 for B-cell NHL; Platelet count > 75,000/mm3 for B-cell NHL; B-ALL: peripheral blast count ≤ 30,000/mm3 prior to first dose
Kidney function
Calculated creatinine clearance > 50 mL/min (Cockcroft-Gault)
Liver function
Total bilirubin <1.5 ULN (may be up to 3x ULN if due to liver mets or Gilbert's); ALT or AST <3 ULN (may be up to 5x ULN if due to liver mets)
Cardiac function
QTcF > 450 msec (male) or 470 msec (female) excluded; LVEF <50% excluded; cardiac troponin I or T > 2.0 ULN excluded; NYHA class III or IV heart failure within <6 months excluded; uncontrolled arrhythmia within <3 months excluded
Clinical laboratory values as specified below during the Screening period. ... Prothrombin time-international normalized ratio (PT-INR) ≤ 1.5ULN. ... Existence of congenital long QT syndrome, QTcF > 450 msec (for male) or 470 msec (for female), use of cardiac pacemaker, left ventricular ejection fraction (LVEF) <50%, clinically significant arrhythmia that requires intervention, cardiac troponin I or T > 2.0 ULN, poorly controlled diabetes (HbA1c > 9%), hypertension (systolic pressure > 160 mmHg or diastolic pressure > 100mmHg)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06037018 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anticancer therapy, radiotherapy, CAR-T cell therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify