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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 (May 2026). This Phase 1 trial studies CC312 for non-hodgkin lymphoma.

Phase 1RecruitingCytoCares IncNCT06037018Data as of May 2026

Treatment: CC312This 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.

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Extracted eligibility criteria

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

Min 1 prior line

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.

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