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Diffuse Large B-cell LymphomaPhase 1/2NCT05192486

A Study of GNC-038, a Tetra-specific Antibody, in Participants With R/R Diffuse Large B-cell Lymphoma (DLBCL)

A Phase 1/2 study testing GNC-038 in people with Diffuse Large B-cell Lymphoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 4 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 and preliminary efficacy of GNC-038 in participants with recurrent or refractory Diffuse Large B-cell lymphoma (DLBCL) 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-038. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diffuse Large B-cell 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
12 participants
Where
4 sitesChina
Study dates
10 Aug 2022to Dec 2025
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

  • he participants could understand and sign the informed consent form, and must participate voluntarily;
  • No gender limit;
  • Age: ≥18 years old and ≤75 years;
  • Expected survival time ≥ 3 months;
  • Has suffered from Diffuse Large B-cell lymphoma (DLBCL) confirmed by histology or cytology;
  • a. Those who have recurrent or refractory Diffuse Large B-cell lymphoma (DLBCL).
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  • Recurrent or refractory participants that are, determined by the investigators, not applicable/tolerated to other treatments.
  • Recurrent and refractory are defined as follows:
  • Recurrent is the progression of disease after adequate treatment to remission, with at least one regimen containing rituximab.
  • Refractory refers to failure to respond to adequate treatment with rituximab containing regimen (combination chemotherapy or monotherapy) or disease progression during treatment/within 6 months of completion of adequate treatment.
  • "Adequate treatment with rituximab regimen" refers to the completion of rituximab combined with chemotherapy based on pathological type and disease stage requirements, or rituximab monotherapy with 375 mg/m2 injections at least 4 times a week. "Progress during treatment" requires completion of at least one cycle of rituximab plus chemotherapy or monotherapy if progress during induction therapy; At least one injection is completed if progress is made during maintenance therapy. "Mitigation" includes complete and partial mitigation.
  • There are measurable lesions during the screening period (any long diameter of lymph node lesions ≥ 1.5 cm or any long diameter of extra-nodal lesions greater than 1.0 cm);
  • Physical fitness score ECOG≤2；
  • The toxicity of the previous anti-tumor therapy has been restored to the level ≤1 defined by NCI-CTCAE v5.0 (the investigators considered indicators that might be associated with the disease, such as anemia, and excluded toxicities that the investigators considered to be of no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy);
  • The organ function within 7 days prior to the first administration meets the following requirements:
  • Bone marrow function: In the case of no blood transfusion, no use of G-CSF (no use of long-acting whitening needles within 2 weeks) and drug correction within 7 days prior to screening, the absolute value of neutrophil count (ANC) ≥1.0×109/L (participants with bone marrow infiltration ≥0.5×109/L); Hemoglobin ≥80 g/L (for participants with bone marrow infiltration, ≥70 g/L); Platelet count ≥50×109/L;
  • Liver function: In the absence of hepatoprotective drugs for correction within 7 days prior to screening, total bilirubin (TBIL) ≤ 1.5 ULN (TBIL ≤3 ULN in participants with Gilbert's syndrome), transaminase (AST/ALT) ≤ 2.5 ULN (participants with tumor infiltration in the liver ≤5.0 ULN);
  • Kidney function: creatinine (Cr) ≤ 1.5 ULN and creatinine clearance (Ccr) ≥ 50 mL/min (according to the Cockcroft and Gault formula);
  • Routine urine / 24h urine protein quantification: qualitative urine protein ≤1+ (if qualitative urine protein ≥2+, 24h urine protein < 1g can be included);
  • Cardiac function: left ventricular ejection fraction ≥50%;
  • Coagulation function: fibrinogen (FIB) ≥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 24 weeks after the administration. Female participants with fertility must have a negative serum/urine pregnancy test in 7 days prior to the first dose.
  • The subjects are able and willing to follow the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.

Who cannot join

  • Has grade 3 or above lung disease defined according to NCI-CTCAE v5.0; Patients with current interstitial lung disease (ILD) (except those who have recovered from previous interstitial pneumonia;
  • Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc;
  • Active tuberculosis;
  • Participants at risk of active autoimmune diseases, such as: systemic lupus erythematosus, systemic treatment of psoriasis, rheumatoid arthritis, inflammatory bowel disease, and hashimoto's thyroiditis, etc., with the exception of type I diabetes, only replacement therapy can control the hypothyroidism, no systemic treatment of skin disease (such as vitiligo, psoriasis), B cells caused by autoimmune disease;
  • Complicated with other malignant tumors within 5 years prior to GNC-038 treatment, except for non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal cancer, breast cancer and localized prostate cancer that have been cured and have not recurred within 5 years;
  • HBsAg or HBcAb positive and HBV-DNA test ≥ULN; HCV antibody positive and HCV-RNA≥ULN; HIV antibody positive;
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  • Participants with poorly controlled hypertension by antihypertensive drugs (systolic blood pressure>150 mmHg or diastolic blood pressure>100 mmHg);
  • History of severe heart disease, including but not limited to:
  • There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias, III grade atrioventricular block, which require clinical intervention;
  • Participants with prolonged QT interval (male QTc > 450 msec or female QTc > 470 msec);
  • Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months before the first administration;
  • New York Heart Association (NYHA) grade II, III or IV congestive heart failure;
  • Patients with a history of allergy to recombinant humanized antibodies or to any excipient component of GNC-038;
  • Pregnant or breastfeeding women;
  • There is an invasion of the central nervous system;
  • Has undergone major surgery within 28 days prior to the administration of this study, or planned to undergo major surgery during the study period (except for surgery such as puncture or lymph node biopsy);
  • Has accepted organ transplantation or allogeneic hematopoietic stem cell transplantation (ALLo-HSCT);
  • Has accepted autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks prior to GNC-038 treatment;
  • Currently using immunosuppressive agents within 2 weeks prior to GNC-038 treatment, including but not limited to: Cyclosporine, tacrolimus, etc.; receiving high-dose glucocorticoids within 2 weeks prior to GNC-038 treatment (longer than 14 days, a stable dose of >30 mg of prednisone or other glucocorticoids at the same dose per day);
  • Has received radiotherapy within 4 weeks prior to GNC-038 treatment;
  • Has received anti-CD20 or anti-CD79b treatment within 4 weeks prior to GNC-038 treatment, and continued to respond;
  • Has received chemotherapy, small molecule targeted drugs within 2 weeks prior to GNC-038 treatment;
  • Has received CAR-T treatment within 12 weeks prior to GNC-038 treatment.
  • Has participated in any other clinical trials within 4 weeks prior to GNC-038 treatment;
  • Other conditions that the investigator believes that it is not suitable for participating in this clinical trial.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Affiliated Hospital of Hebei University

    Baoding, Hebei

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • Ruijin Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong

Other trials in China

About this study

Official title: An Open-Label, Multi-Center, Phase Ib/II Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Tetra-specific Antibody GNC-038 in Participants With Recurrent or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

In this study, the safety and preliminary efficacy of GNC-038 in participants with recurrent or refractory Diffuse Large B-cell lymphoma (DLBCL) 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-038. The recommended dose for phase II (RP2D) clinical study will also be determined.

Being tested
GNC-038
Keywords
DLBCL
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

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 NCT05192486
Study groupRoleWhat they receive
Study treatmentExperimentalParticipants receive GNC-038 as intravenous infusion for the first cycle (3 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 during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0).

    Measured: Up to 21 days after the first dose of GNC-038

  2. Maximum tolerated dose (MTD) or maximum administrated 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 21 days after the first dose of GNC-038

  3. Treatment-Emergent Adverse Event (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. The recommended dose for phase II clinical study（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 21 days after the first dose of GNC-038

Secondary outcomes (15)

  1. ORR (Objective Response Rate )

    ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

    Measured: Up to approximately 24 months

  2. PFS (Progression-free Survival)

    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. DCR (Disease Control Rate)

    The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).

    Measured: Up to approximately 24 months

  4. 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

  5. CR (Complete Response)

    Disappearance of all target lesions.

    Measured: Up to approximately 24 months

  6. 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

  7. Peak Plasma Concentration（Cmax)

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

    Measured: Up to 21 days after the first dose of GNC-038

  8. Incidence and titer of ADA (Anti-drug antibody)

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

    Measured: Up to approximately 24 months

  9. Incidence and titer of Nab

    Incidence and titer of Nab of GNC-038 will be evaluated.

    Measured: Up to approximately 24 months

  10. Trough steady-state concentration（Css）

    Concentration of GNC-038 at steady state plateau will be investigated.

    Measured: Up to 14 days after the first dose of GNC-038

  11. Time to reach maximum concentration (Tmax)

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

    Measured: Up to 21 days after the first dose of GNC-038

  12. AUC0-inf

    Area under the plasma concentration-time curve from time 0 extrapolated to infinite (AUC0-inf).

    Measured: Up to 21 days after the first dose of GNC-038

  13. AUC0-t

    Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t).

    Measured: Up to 21 days after the first dose of GNC-038

  14. Plasma clearance （CL）

    To study the serum clearance rate of GNC-038 per unit time.

    Measured: Up to 21 days after the first dose of GNC-038

  15. Elimination half life （T1/2）

    Half-life (T1/2) of GNC-038 will be investigated.

    Measured: Up to 21 days after the first dose of GNC-038

Timeline

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

  1. First posted14 Jan 2022
  2. Study start10 Aug 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05192486
Sponsor's protocol ID
GNC-038-102
Status last verified
Sep 2025
First submitted
15 Dec 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 1/2 study testing GNC-038 in people with Diffuse Large B-cell Lymphoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 4 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 23 inclusion and 25 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 4 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?

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?

Dose limiting toxicity (DLT) (time frame: Up to 21 days after the first dose of GNC-038). 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 NCT05192486.

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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