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Hematologic MalignanciesPhase 1NCT05104775

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

A Phase 1 study testing GNC-035 in people with Hematologic Malignancies, run by Sichuan Baili Pharmaceutical Co., Ltd. at 7 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hematologic Malignancies
What is being tested?
GNC-035
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
7 sitesChina
Study dates
9 Feb 2022to Dec 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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;
  • Relapsed ALL is defined as the presence of blasts (> 5%) in the peripheral blood or bone marrow, or the presence of extramedullary disease in patients who have achieved CR; mediastinal enlargement in patients who have achieved CR.
  • Special circumstances: There is no clear classification standard for adult ALL patients with number of relapse ≥ 2, persistent extramedullary leukemia and persistent positive minimal residual disease (MRD). However, most clinical trials classified these patients as refractory cases.
  • Patients with relapsed or refractory acute B-lymphoblastic leukemia who, in the opinion of the investigator, have no or no indication/intolerance to other therapy.
  • Relapsed/refractory acute myeloid leukemia (AML), relapsed/refractory AML is defined as one of the following:
  • Initial treatment who failed to respond to 2 courses of standard regimen;
  • Patients with relapse within 12 months , consolidation and intensive treatment after complete remission;
  • Patients who relapsed after 12 months but failed to respond to conventional chemotherapy;
  • Patients with two or more recurrences;
  • Patients with persistent extramedullary leukemia;
  • Patients with relapsed or refractory acute myeloid leukemia who have no or no indication/intolerance to other therapy as judged by the investigator.
  • Patients with Philadelphia chromosome positive (Ph +) acute lymphoblastic leukemia are eligible if they are intolerant or have failed first and/or second generation tyrosine kinase inhibitors (TKIs); patients with a positive T315I mutation do not require TKI salvage
  • For non-Hodgkin lymphoma, measurable lesions on CT (any lymph node lesion ≥ 1.5 cm in long diameter or > 1.0 cm in long diameter for extranodal lesions) at screening; CLL/SLL: peripheral blood leukemia cells ≥ 5.0 × 109/L; or any lymph node lesion ≥ 1.5 cm in long diameter; WM: IgM 2 × ULN;
  • For patients with acute lymphoblastic leukemia, ≥ 5% lymphoblasts in the bone marrow by morphologic assessment
  • For patients with acute myeloid leukemia, ≥ 5% blasts in the bone marrow by morphologic assessment
  • ECOG Performance Status ≤ 2
  • Recovery from toxicities of prior anticancer therapy to ≤ Grade 1 as defined by NCI-CTCAEv5.0 (except alopecia)
  • The organ function level within 7 days before the first administration meets the following requirements:
  • Bone marrow function (only for patients with non-Hodgkin's lymphoma): Neutrophils without blood transfusion, G-CSF (without long-acting whitening needles within 2 weeks) and drug correction within 7 days before screening Absolute count (ANC) ≥1.0×10^9/L (for subjects with bone marrow infiltration, ≥0.5×10^9/L); hemoglobin ≥80 g/L (for subjects with bone marrow infiltration, ≥70g /L); Platelet count ≥50×10^9/L; Liver function: In the case of no hepatoprotective drugs for correction within 7 days before screening, total bilirubin ≤ 1.5 ULN (Gilbert's syndrome ≤ 3 ULN), transaminase (AST/ALT) ≤ 2.5 ULN (tumor invasive changes in the liver) Subject ≤5.0 ULN), and/or alkaline phosphatase ≤5 ULN; Kidney function: creatinine (Cr) ≤ 1.5 ULN or creatinine clearance (Ccr) ≥ 50 mL/min (calculated by the research center); Coagulation function: fibrinogen ≥ 1.5g/L; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; prothrombin time (PT) ≤ 1.5 × ULN;
  • Female participants with fertility or male participants whose partner(s) are fertile must take effective contraceptive measures from 7 days prior to the first administration to 12 weeks after the administration. Female participants with fertility must have a negative serum/urine pregnancy test in 7 days prior to the first dose.
  • Subjects are capable and willing to comply with the visits, treatment plans, laboratory examinations and other research-related procedures stipulated in the research protocol.

Who cannot join

  • 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)
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  • 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);
  • Radiotherapy 4 times before starting GNC-035 treatment; chemotherapy and small molecule targeted drugs 2 weeks before treatment
  • CD19 or anti-CD22 treatment and still respond, received Amgen Belintotumomab (CD19×CD3), inotuzumab-oxazomicin (CD22-ADC) treatment within 4 weeks before treatment;
  • Received CAR-T 12 weeks prior to starting GNC-035
  • Has receivedany other clinical trial within 4 weeks prior to GNC-035 treatment
  • The investigator believes that it is not suitable to participate in other situations in this clinical trial.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei

  • The Second People's Hospital of Yibin

    Yibin, Sichuang

Other trials in China

About this study

Official title: An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability，Pharmacokinetic/Pharmacodynamics and Anti-tumor Activity of Tetra-specific Antibody GNC-035 in Participants With Relapsed/Refractory Hematologic Malignancy and Locally Advanced or Metastatic Solid Tumors

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.

Being tested
GNC-035
Keywords
Relapsed/Refractory Acute B-lymphoblastic Leukemia, Relapsed/Refractory Acute Myeloid Leukemia
Medical subject headings
Hematologic Neoplasms, Recurrence, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GNC-035Drug

    Administration by intravenous infusion.

Study groups in NCT05104775
Study groupRoleWhat they receive
study treatmentExperimentalPatients 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.
Receives: Drug: GNC-035

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT

    Dose limiting toxicity

    Measured: Up to 2 weeks

  2. MTD or MAD

    Maximum tolerated dose or maximum administrated dose

    Measured: Up to 2 weeks

  3. TEAE

    Treatment-Emergent Adverse Event

    Measured: Up to 2 years

  4. The recommended dose for future clinical study

    The recommended dose for future clinical study

    Measured: Up to 2 weeks

  5. RP2D

    Recommended phase II dose

    Measured: Up to 2 years

Secondary outcomes (9)

  1. AESI

    Adverse Events of special interest

    Measured: Up to 2 years

  2. Cmax

    Maximum serum concentration of GNC-035

    Measured: Up to 2 weeks

  3. Tmax

    Time to maximum serum concentration (Tmax) of GNC-035

    Measured: Up to 2 weeks

  4. T1/2

    Half-life of GNC-035

    Measured: Up to 2 weeks

  5. Incidence and titer of ADA

    Anti-drug antibody

    Measured: Up to 2 years

  6. ORR

    Objective Response Rate

    Measured: Up to 2 years

  7. DCR

    Disease Control Rate

    Measured: Up to 2 years

  8. PFS

    Progression-free Survival

    Measured: Up to 2 years

  9. DOR

    Duration of Response

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2021
  2. Study start9 Feb 2022
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05104775
Sponsor's protocol ID
GNC-035-101
Status last verified
Sep 2025
First submitted
21 Oct 2021
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GNC-035 in people with Hematologic Malignancies, run by Sichuan Baili Pharmaceutical Co., Ltd. at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: Up to 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05104775.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.

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