A Study of GNC-035, a Tetra-specific Antibody, in Participants With Relapsed/Refractory Hematologic Malignancy

NCT05104775 | Active Not Recruiting Phase 1

• 1 other identifier: GNC-035-101
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 7

Brief Summary

In this study, the safety, tolerability and preliminary effectiveness of GNC-035 in patients with relapsed/refractory hematologic malignancies will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-035.

Conditions

Hematologic Malignancies

Keywords

Relapsed/Refractory Acute B-lymphoblastic Leukemia; Relapsed/Refractory Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (5)

• DLT

  Dose limiting toxicity

  Up to 2 weeks

• MTD or MAD

  Maximum tolerated dose or maximum administrated dose

  Up to 2 weeks

• TEAE

  Treatment-Emergent Adverse Event

  Up to 2 years

• The recommended dose for future clinical study

  The recommended dose for future clinical study

  Up to 2 weeks

• RP2D

  Recommended phase II dose

  Up to 2 years

Secondary Outcomes (9)

• AESI

  Up to 2 years

• Cmax

  Up to 2 weeks

• Tmax

  Up to 2 weeks

• T1/2

  Up to 2 weeks

• Incidence and titer of ADA

  Up to 2 years

Study Arms (1)

study treatment

EXPERIMENTAL

Patients receive GNC-035 as a 24-hour continuous intravenous infusion (cIV, QD) for 2 weeks (a 2-week cycle). Participants with no intolerable AEs could continue for another three cycles.

Drug: GNC-035

Interventions

GNC-035 DRUG

Administration by intravenous infusion.

study treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participants could understand and sign the informed consent form, and must participate voluntarily
• No gender limit
• Age: ≥18 and ≤75 years old
• Life expectancy estimated to be at least 3 months
• Histologically or cytologically confirmed relapsed or refractory non-Hodgkin's lymphoma, relapsed/refractory chronic lymphocytic leukemia, relapsed/refractory acute B-lymphoblastic leukemia, or relapsed/refractory acute myeloid leukemia
• For relapsed or refractory chronic lymphocytic leukemia (CLL/SLL), specifically:
• Patients who have relapsed after at least 1 line of standard therapy or who have failed or are intolerant to standard therapy;
• Patients with relapsed or refractory chronic lymphocytic leukemia who, in the opinion of the investigator, have none or are not suitable/intolerant to other therapies;
• For other patients with relapsed and refractory non-Hodgkin's lymphoma. These include:
• Patients in first relapse who still progress during second-line treatment;
• Patients who relapsed after second-line or multi-line therapy;
• Refractory patients are defined as those who do not respond or progress after adequate dose and full cycle of standard or current commonly selected combination therapy regimens, and do not respond or progress after replacement of second-line regimens;
• Relapsed or refractory patients who are judged by the investigator to have no or no indication/intolerance to other therapy.
• Relapsed or refractory acute B-lymphoblastic leukemia, including:
• Definition of refractory ALL: failure to achieve CR after standard induction therapy for bone marrow and peripheral blood response;

You may not qualify if:

• Patients who have undergone major surgery within 28 days prior to dosing in this study, or are scheduled to undergo major surgery during this study ("major surgery"is defined by the investigator)
• Pulmonary disease ≥ grade 3 according to NCI-CTCAEv5.0: including resting dyspnea, or requiring continuous oxygen therapy; patients with current interstitial lung disease (ILD) (except for those with previous interstitial pneumonia)
• Systemic serious infections occurred within 4 weeks before screening，including but not limited to severe pneumonia, bacteremia or serious infectious complications caused by fungi, bacteria and viruses
• Patients with active autoimmune diseases, or patients with a history of autoimmune diseases
• Patients complicated with other malignant tumors within 5 years before the first dose, and cured non-melanoma in situ skin cancer, superficial bladder cancer, in situ cervical cancer, gastrointestinal intramucosal cancer, breast cancer, localized prostate cancer and other cancers that are considered by the investigator to be eligible
• Positive human immunodeficiency virus antibody (HIVAb), active tuberculosis, active hepatitis B virus infection (positive HBsAg or positive HBcAb with HBV-DNA ≥ ULN), or hepatitis C virus infection (positive HCV antibody with HCV-RNA ≥ ULN)
• Hypertension poorly controlled on medication (systolic \> 150 mmHg or diastolic \> 100 mmHg)
• Left ventricular ejection fraction ≤ 45%, or history of significant cardiac disease within 1 year
• Patients with a history of hypersensitivity to recombinant humanized antibodies or hypersensitivity to any of the excipient components of GNC-035
• Women who are pregnant or breastfeeding
• Previous or concomitant central nervous system disease
• With CNS involvement
• Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (ALLo-HSCT)
• Autologous hematopoietic stem cell transplantation (Auto-HSCT) was performed 12 weeks before starting GNC-035 treatment
• Are using immunosuppressive agents, including but not limited to: Cyclosporine, tacrolimus, etc. within 2 weeks before GNC-035 treatment; High-dose glucocorticoids (longer than 14 days) within 2 weeks before GNC-035 treatment , A daily stable dose of \>30mg of prednisone or the same dose of other glucocorticoids);

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• SystImmune Inc.: collaborator

Study Sites (7)

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Location

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

The Second People's Hospital of Yibin

Yibin, Sichuang, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Recurrence; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type

Study Officials

• Weili Zhao

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

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: October 21, 2021
• First Posted: November 3, 2021
• Study Start: February 9, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)