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

NCT06037018 | Recruiting Phase 1

• 1 other identifier: CC312-001(C)
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-hodgkin Lymphoma; Acute Lymphoblastic Leukaemia; Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicities (DLTs)

  Toxicity will be evaluated according to the NCI CTCAE, Version 5.0, except CRS which will be graded according to ASTCT Consensus Grading for CRS.

  From the first infusion of CC312 till the end of the 28 days DLT（Dose Limiting Toxicity）observation period.

• Incidence and severity of adverse event (AE)

  Overall numbers of participants with any AE, including any laboratory abnormality, treatment-emergent adverse event (TEAE), and serious adverse events (SAE). Severity (toxicity grade) for each AE will be determined using the NCI CTCAE, version 5.0; except cytokine release syndrom (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) which will be graded according to ASTCT Consensus Grading.

  From the first infusion of CC312 until 28 days following the end of treatment.

Secondary Outcomes (4)

• Pharmacokinetics (PK): serum concentration

  Cycle 1: baseline (Day -10~Day -8); 1 hour-pre-dose and multiple-timepoints-post-dose; Cycle 2 and subsequent cycle: 1 hour-pre-dose; after the end of treatment (EOT)/withdraw/at the end of study (EOS). Length of each cycle: 28 days.

• Pharmacodynamics (PD): cytokine analysis

  Cycle 1: baseline (Day -10~Day -8); 1 hour-pre-dose and multiple-timepoints-post-dose; Cycle 2 and subsequent cycle: 1 hour-pre-dose; after the end of treatment (EOT)/withdraw/at the end of study (EOS). Length of each cycle: 28 days.

• Pharmacodynamics (PD): immunophenotyping

  Cycle 1: baseline (Day -10~Day -8); 1 hour-pre-dose and multiple-timepoints-post-dose; Cycle 2 and subsequent cycle: 1 hour-pre-dose; after the end of treatment (EOT)/withdraw/at the end of study (EOS). Length of each cycle: 28 days.

• Immunogenicity: anti-CC312 antibody

  Cycle 1: baseline (Day -10~Day -8); 1 hour-pre-dose on Day-7/Day 8. Cycle 2 and subsequent cycle: within 1 hour before infusion on Day 1/Day 15; after the end of treatment (EOT)/withdraw/at the end of study (EOS). Length of each cycle: 28 days.

Other Outcomes (1)

• Tumor response to CC312

  From the first infusion of CC312 until 28 days following the end of treatment.

Study Arms (1)

CC312

EXPERIMENTAL

Biological: CC312

Interventions

CC312 BIOLOGICAL

Doses from 0.3 to 45 µg/dose by intravenous infusion

CC312

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• Patients with brain metastases or other significant neurological conditions, except for brain metastases which are asymptomatic and radiologically stable without need for steroids for 2 weeks before the first dose of CC312;
• Treatment with corticosteroids (\>10mg daily prednisone or equivalent) or immunosuppressive medication ≤ 7 days before the first dose of CC312, with the following exceptions:
• Topical, ocular, intra-articular, intranasal, or inhalational corticosteroids;
• Use of dexamethasone to reduce peripheral blast counts in ALL;
• Vaccination with a live virus vaccine within 4 weeks prior to the study enrollment;
• Current autoimmune disease or history of autoimmune disease with potential CNS involvement;
• Known to be allergic to protein drugs or recombinant proteins or excipients in the CC312 drug formulation. Patients who experienced Grade 3 reactions that lasted \< 24h may be eligible after discussion with investigator；
• Except for the tolerable events determined by the investigator, any toxic effects of the prior therapy which have not resolved to Grade 1 (CTCAE v5.0);
• Admission or evidence of illicit drug use, drug abuse, or alcohol abuse;
• Cerebrovascular accident (CVA), Transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, or New York Heart Association (NYHA) class III or IV heart failure occurring within \<6 months of study entry; uncontrolled arrhythmia within \< 3 months of study entry. Patients with rate-controlled arrhythmias may be eligible for study entry at discretion of the Investigator.;

Sponsors & Collaborators

• CytoCares Inc: lead

Study Sites (1)

InstituteHBDH

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• JUNYUAN QI, MD

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZHEN JING, MM

CONTACT

86-21-50582090; zhen.jing@cytocares.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 14, 2023
• Study Start: August 7, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

CN (1)