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NK/T Cell LymphomaPhase 1/2NCT05627856

A Study of GNC-038 Injection in Patients With Relapsed or Refractory NK/ T-cell Lymphoma, AITL, and Other NHL

A Phase 1/2 study testing GNC-038 in people with NK/T Cell Lymphoma and Vascular Immunomother T Cell Lymphoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 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

To explore the safety and efficacy of GNC-038 in relapsed or refractory NK/T cell lymphoma, vascular immunomother T cell lymphoma, and other relapsed or refractory NHL, and to determine MTD, MAD, DLT, and RP2D of GNC-038, as well as its pharmacokinetic characteristics and immunogenicity. Read more about this study

Who is it for?
Ages 18 to 75 years
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
4 participants
Where
2 sitesChina
Study dates
21 Feb 2023to 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

  • Subjects can understand the informed consent, voluntarily participate in and sign the informed consent.
  • No gender restriction.
  • Age: ≥18 and ≤75 years old.
  • Expected survival time ≥3 months.
  • Patients with histologically confirmed NK/T cell lymphoma or vascular immunomother T cell lymphoma.
  • Patients with relapsed/refractory NK/T cell lymphoma (R/R NKTCL) or relapsed/refractory vascular immunomother T cell lymphoma (AITL):
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  • 1) Patients with recurrent or refractory vascular immunomother T cell lymphoma after initial treatment.
  • 2) Patients with NK/T cell lymphoma need to have received systematic therapy with asparaginase regimen in the past, and have received radiotherapy for single lesion recurrence or refractory treatment.
  • Difficult-to-treat definition: i) the curative effect of end-line treatment did not reach PR; Or ii) disease progression within 6 months after terminal line treatment.
  • 7. In the screening period, there were measurable lesions (lymph node lesions with any length ≥1.5cm or exodal lesions with any length > 1.0cm, all of which had metabolic activity).
  • 8. Physical status score ECOG ≤2 points. 9. The adverse reactions of previous antitumor therapy were restored to CTCAE level 5.0 evaluation ≤ level 1 (except for indicators that the researchers considered might be related to the disease, such as anemia, and toxicities that the researchers judged to have no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.).
  • 10. Organ function level before initial administration meets the following requirements: Bone marrow function: without blood transfusion within 7 days prior to screening, without G-CSF (without long-acting rising white needle within 2 weeks) and drug correction: Absolute neutrophil count (ANC) ≥1.0×109/L (≥0.5×109/L for subjects with bone marrow infiltration); Hemoglobin ≥80 g/L (≥70g/L for subjects with bone marrow infiltration); Platelet count ≥75×109/L; Liver function: total bilirubin ≤1.5 ULN (Gilbert's syndrome ≤3 ULN), transaminase (AST/ALT) ≤2.5 ULN (subjects with liver tumor invasive changes ≤5.0 ULN) within 7 days before screening without liver protection drugs; Renal function: creatinine (Cr) ≤1.5 ULN and creatinine clearance (Ccr) ≥50 ml/min (according to Cockcroft and Gault formula); Urine routine /24 hours urine protein quantification: qualitative urine protein ≤1+ (if qualitative urine protein ≥2+, 24 hours urine protein < 1g can be included in the group); Cardiac function: left ventricular ejection fraction ≥50%; Coagulation function: fibrinogen ≥1.5g/L; Activated partial thrombin time (APTT) ≤1.5 ULN; Prothrombin time (PT) ≤1.5 ULN.
  • 11. Fertile female subjects or fertile male subjects with partners must use highly effective contraception from 7 days prior to the first dose until 12 weeks after termination of treatment. A fertile female subject must have a negative serum/urine pregnancy test within 7 days prior to initial dosing.
  • 12. Subject is able and willing to comply with visits, treatment plans, laboratory tests, and other study-related procedures as specified in the study protocol.

Who cannot join

  • According to NCI-CTCAE v5.0, it was defined as ≥ grade 3 pulmonary disease; Patients who currently have interstitial lung disease (ILD) (except those who previously had interstitial pneumonia and have recovered).
  • Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.
  • Active tuberculosis.
  • Patients with hemophagocytic syndrome.
  • Patients with lesions invading pulmonary great vessels.
  • Active patients with 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 (e.g., vitiligo, psoriasis), B cells caused by autoimmune disease.
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  • Non-melanoma skin cancer in situ, superficial bladder cancer in situ, cervical cancer in situ, gastrointestinal intramucosal cancer, breast cancer, localized prostate cancer and other malignant tumors that were combined with other malignant tumors within 5 years prior to the first administration of the drug, except those that the researchers thought could be included.
  • HBsAg positive or HBcAb positive, and HBV-DNA detection ≥ detection value lower limit (HBV-DNA detection in the normal range and regular use of anti-HBV drugs except patients); HCV antibody was positive and HCV-RNA≥ lower limit of detection value.
  • Poorly controlled hypertension (systolic blood pressure \&gt;160 mmHg or diastolic blood pressure \&gt;100 mmHg).
  • A history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias and degree III atrioventricular block that require clinical intervention; Prolonged QT interval at rest (QTc > 450 msec in men or 470 msec in women); Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurring within 6 months prior to initial administration; Present with heart failure ≥II on the New York Heart Association (NYHA) cardiac function scale.
  • Patients with a history of allergy to recombinant humanized antibodies or to any excipient component of GNC-038.
  • Pregnant or breastfeeding women.
  • Patients with central nervous system invasion.
  • Patients who received major surgery within 28 days prior to drug administration in this study, or planned to undergo major surgery during the study period (except for procedures such as puncture or lymph node biopsy).
  • Previous recipients of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
  • Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 24 weeks before starting GNC-038 therapy.
  • Immunosuppressants are being used, including, but not limited to, cyclosporine, tacrolimus, etc. within 2 weeks prior to treatment with GNC-038.
  • Radiotherapy was received within 4 weeks prior to the initiation of GNC-038 therapy.
  • Received chemotherapy and small molecule targeted therapy within 2 weeks prior to treatment.
  • Received CAR-T therapy within 12 weeks prior to initiation of GNC-038 therapy.
  • Participants in any other clinical trial within 4 weeks prior to administration of this trial.
  • A history of immunodeficiency, including HIV positive testing, or other acquired, congenital immunodeficiency diseases.
  • Other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510050

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: An Open, Multicenter, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacokinetics, and Antitumor Activity of GNC-038 Injection in Relapsed or Refractory NK/ T-cell Lymphoma, AITL, and Other NHL

To explore the safety and efficacy of GNC-038 in relapsed or refractory NK/T cell lymphoma, vascular immunomother T cell lymphoma, and other relapsed or refractory NHL, and to determine MTD, MAD, DLT, and RP2D of GNC-038, as well as its pharmacokinetic characteristics and immunogenicity.

Read the detailed description

Phase Ib: To explore the safety and preliminary effectiveness of GNC-038 under the administration mode of "intravenous infusion for 2h to 4h, once a week (IV, QW), 2 weeks as one cycle", and to determine MTD, MAD, DLT and RP2D of GNC-038. The pharmacokinetic characteristics and immunogenicity of GNC-038 will be evaluated. Phase II: To explore the efficacy, safety and tolerability, pharmacokinetic characteristics and immunogenicity of GNC-038.

Being tested
GNC-038
Medical subject headings
Lymphoma, Extranodal NK-T-Cell, 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 NCT05627856
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. Phase Ib: Dose Limited 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 16 days after the first dose

  2. Phase Ib: Maximum Tolerated dose (MTD) or maximum administered 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 16 days after the first dose

  3. Phase Ib: 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. Phase Ib: Recommended Phase II Dose (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 16 days after the first dose

  5. Phase II: Objective response rate (ORR)

    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

Secondary outcomes (17)

  1. Phase Ib: Objective response rate (ORR)

    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. Phase Ib: 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. Phase Ib: Disease control rate (DCR)

    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. Phase Ib:Duration of response (DOR)

    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. Phase Ib: Complete Response (CR)

    Disappearance of all target lesions.

    Measured: Up to approximately 24 months

  6. Phase Ib: 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. Phase Ib: Cmax

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

    Measured: Up to 16 days after the first dose

  8. Phase Ib:Tmax

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

    Measured: Up to 16 days after the first dose

  9. Phase Ib:AUC0-inf

    Blood concentration - Area under time line.

    Measured: Up to 16 days after the first dose

  10. Phase Ib: AUC0-T

    Blood concentration - Area under time line.

    Measured: Up to 16 days after the first dose

  11. Phase Ib: CL(Clearance)

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

    Measured: Up to 16 days after the first dose

  12. Phase Ib: T1/2

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

    Measured: Up to 16 days after the first dose

  13. Phase Ib: Anti-drug antibody (ADA)

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

    Measured: Up to approximately 24 months

  14. Phase II: 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

  15. Phase II: Disease control rate (DCR)

    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

  16. Phase II:Duration of response (DOR)

    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

  17. Phase II: 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

Timeline

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

  1. First posted28 Nov 2022
  2. Study start21 Feb 2023
  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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05627856
Sponsor's protocol ID
GNC-038-105
Status last verified
Sep 2025
First submitted
8 Nov 2022
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GNC-038 in people with NK/T Cell Lymphoma and Vascular Immunomother T Cell Lymphoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 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 14 inclusion and 24 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 2 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?

Phase Ib: Dose Limited Toxicity (DLT) (time frame: Up to 16 days after the first dose). 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 NCT05627856.

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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