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Non-hodgkin's LymphomaPhase 1/2NCT05623982

A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

A Phase 1/2 study testing GNC-038 in people with Non-hodgkin's Lymphoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2D of GNC-038, or the MAD and DLT Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-hodgkin's Lymphoma
What is being tested?
GNC-038
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesChina
Study dates
26 Sep 2022to Dec 2027
Phase
Phase 1/2
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 subject is capable of understanding the informed consent form, voluntarily participates, and signs the informed consent form;
  • No gender restrictions;
  • Age: ≥18 years and ≤75 years;
  • Expected survival time ≥3 months;
  • Patients with histologically confirmed non-Hodgkin's lymphoma;
  • Patients with relapsed or refractory non-Hodgkin's lymphoma (R/R NHL);
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  • Presence of measurable lesions during the screening period (lymph node lesions with any long diameter ≥1.5 cm or extranodal lesions with any long diameter >1.0 cm);
  • ECOG performance status score ≤2;
  • Adverse reactions from prior anti-tumor treatment have recovered to ≤Grade 1 as per CTCAE 5.0 criteria;
  • Organ function levels meet the requirements before the first dose;
  • Female subjects of childbearing potential or male subjects with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 12 weeks after treatment discontinuation. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose;
  • The subject has the ability and willingness to comply with the study protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

Who cannot join

  • Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0; patients currently diagnosed with interstitial lung disease (ILD);
  • Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
  • Active tuberculosis;
  • Patients with active autoimmune diseases;
  • History of other malignancies within 5 years prior to the first dose;
  • HBsAg-positive and/or HBcAb-positive with HBV-DNA levels ≥ the lower limit of detection; HCV antibody-positive with HCV-RNA levels ≥ the lower limit of detection; HIV antibody-positive;
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  • Poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg);
  • History of severe cardiovascular or cerebrovascular diseases;
  • Patients with a history of hypersensitivity to recombinant humanized antibodies or any excipients of GNC-038;
  • Pregnant or lactating women;
  • Patients with central nervous system involvement;
  • Major surgery within 28 days before the first dose of this study or planned major surgery during the study period;
  • Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
  • Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before initiating GNC-038 treatment;
  • Current use of immunosuppressive therapy;
  • Radiotherapy within 4 weeks before initiating GNC-038 treatment;
  • Chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives prior to treatment;
  • CAR-T therapy within 12 weeks before initiating GNC-038 treatment;
  • Use of any other investigational drug in a clinical trial within 4 weeks or 5 half-lives before the first dose of this study;
  • Any other condition deemed unsuitable for participation in this clinical trial by the investigator.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

+86-15013238943

xiaosa@baili-pharm.com

China3 sites, 3 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Jun Zhu

    Yuqin Song

    Recruiting

  • Harbin First Hospital

    Haerbin, Heilongjing

    Zhiguo Wang

    Recruiting

  • Qingdao Central Hospital

    Qingdao, Shandong

    Ling Wang

    Recruiting

Other trials in China

About this study

Official title: An Open, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Tetra-specific Antibody GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)

To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2D of GNC-038, or the MAD and DLT

Read the detailed description

phase Ib: To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2Dof GNC-038, or the MAD and DLT of GNC-038 if MTD is not reached, by intravenous infusion (IV, QW) once a week (2 weeks as a cycle) phase II To explore the efficacy of GNC-038 in patients with relapsed or refractory non-Hodgkin's lymphoma

Being tested
GNC-038
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • GNC-038Drug

    Administration by intravenous infusion

Study groups in NCT05623982
Study groupRoleWhat they receive
Study treatmentExperimentalParticipants receive GNC-038 as intravenous infusion for the first cycle (2 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Receives: Drug: GNC-038

What is being measured

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

  1. Dose limiting toxicity (DLT)

    The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0).

    Measured: Up to 14 days after the first dose

  2. Maximum tolerated dose (MTD) or Maximum dose (MAD)

    In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.

    Measured: Up to 14 days after the first dose

  3. Adverse Events during Treatment (TEAE)

    TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of GNC-038. The type, frequency and severity of TEAE will be evaluated during the treatment of GNC-038.

    Measured: Up to approximately 24 months

  4. Recommended dose for Phase II clinical studies (RP2D)

    The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of GNC-038.

    Measured: Up to 14 days after the first dose

Secondary outcomes (10)

  1. disease control rate (DCR)

    Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response.

    Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response.

    Measured: Up to approximately 24 months

  2. progression-free survival (PFS)

    The PFS is defined as the time from the participant's first dose of GNC-038 to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 24 months

  3. Adverse Events of Special Interest (AESI)

    AESI is an event of scientific and medical interest specific to the sponsor's product or research project.

    Measured: Up to approximately 24 months

  4. Cmax

    Maximum serum concentration (Cmax) of GNC-038 will be investigated.

    Measured: Up to approximately 24 months

  5. Tmax

    Time to maximum serum concentration (Tmax) of GNC-038 will be investigated.

    Measured: Up to approximately 24 months

  6. AUC0-INF

    Blood concentration - Area under time line.

    Measured: Up to approximately 24 months

  7. AUC0-T

    Blood concentration - Area under time line.

    Measured: Up to approximately 24 months

  8. T1/2

    Blood concentration - Area under time line.

    Measured: Up to approximately 24 months

  9. anti-drug antibody (ADA) in Ⅰa

    Frequency and titer of anti-GNC-038 antibody (ADA).

    Measured: Up to approximately 24 months

  10. DOR (Duration of Response)

    The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 24 months

Timeline

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

  1. First posted21 Nov 2022
  2. Study start26 Sep 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05623982
Sponsor's protocol ID
GNC-038-104
Status last verified
Aug 2026
First submitted
25 Aug 2022
Last updated
27 Aug 2026
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 1/2 study testing GNC-038 in people with Non-hodgkin's Lymphoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 3 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 12 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Sa Xiao, PHD (+86-15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) (time frame: Up to 14 days after the first dose). The study lists 4 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 NCT05623982.

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 27 Aug 2026.

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