AzTrials
AzTrials

Non Hodgkin LymphomaPhase 1NCT04606433

Phase I Clinical Study of GNC-038 in Patients With Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia

A Phase 1 study testing GNC-038 in people with Non Hodgkin Lymphoma and Acute Lymphoblastic Leukemia, run by Sichuan Baili Pharmaceutical Co., Ltd. at 10 sites in China.

Active, not recruiting

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

Official record
Search all trials

Trial summary

An open, multicenter, Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics/pharmacokinetics, and antitumor activity of GNC-038 quad-specific antibody injection in relapsed or refractory non-Hodgkin's lymphoma, relapsed or refractory acute lymphoblastic leukemia, and refractory or metastatic… Read more about this study

Who is it for?
Ages 18 years and older
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
47 participants
Where
10 sitesChina
Study dates
4 Nov 2020to 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 years and older
  • 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 years old.
  • Expected survival time ≥ 3 months.
  • Histologically or cytologically confirmed non-Hodgkin's lymphoma or acute lymphoblastic leukemia.
  • Patients with relapsed refractory non-Hodgkin lymphoma (R/R NHL). Specifically, patients who relapsed for the first time and still progressed during second-line treatment; Patients with relapse after second-line or multiline therapy; Refractory patients showed no remission or progress after full dose and full cycle use of standard or current clinically commonly selected combination therapy regimen, and no remission or progress after replacement of second-line regimen; Patients with relapsed or refractory non-Hodgkin lymphoma who were determined to have no or no other treatments available/intolerant.
Show all 15Show fewer
  • Relapsed or refractory acute lymphoblastic leukemia (R/R ALL), including: no response after more than 6 weeks of induction chemotherapy, or no response after 2 cycles of induction chemotherapy; A second or more recurrence of bone marrow; Or relapse for the first time after chemotherapy with no remission after at least 1 cycle of salvage therapy; Bone marrow recurrence after autologous stem cell transplantation (auto-HSCT); Patients with relapsed or refractory acute lymphoblastic leukemia were determined to have no or no other treatments/intolerant.
  • Patients with Philadelphia chromosome positive (Ph+) ALL who are intolerant to or fail to treat 1 and/or 2 generation tyrosine kinase inhibitors (TKI), or Ph+ALL who have a T315I mutation, do not require TKI salvage therapy.
  • For patients with NHL, there were measurable lesions in the screening period (lymph node lesions with any length ≥1.5cm or exodal lesions with any length > 1.0cm); CLL/SLL: peripheral blood leukemia cells ≥5.0×109/L; Or lymph node lesions of any length ≥1.5cm; WM: IgM> 2 x ULN.
  • For AITL and NK/T lymphoma, a membrane CD3 negative test is required.
  • Physical status score ECOG ≤2 points.
  • The toxicity of previous antitumor therapy has returned to ≤ Class 1 as defined by NCI-CTCAE v5.0 (except for toxicities that the investigators judged to be of no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, and stable hypothyroidism after hormone replacement therapy).
  • The organ function level meets the following requirements: Bone marrow function (for NHL patients only) : without blood transfusion within 7 days prior to screening, without G-CSF (without long-acting rising white needle within 2 weeks), and without 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 ≥50×109/L; Liver function: Total bilirubin ≤1.5 ULN (Gilbert's syndrome ≤3 ULN), transaminase (AST/ALT) ≤2.5ULN (in subjects with tumor invasive changes in the liver ≤5.0 ULN), and/or alkaline phosphatase ≤5 ULN when not corrected with hepatoprotective drugs within 7 days prior to screening; Renal function: creatinine (Cr) ≤1.5 ULN and creatinine clearance (Ccr) ≥50 ml/min (based on the center's calculation criteria). The investigators judged renal function intact without injury, except that abnormal creatinine index was caused by tumor. Coagulation function: fibrinogen ≥1.5g/L; Activated partial thromboplastin time (APTT) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN.
  • Fertile female subjects or male subjects with fertile partners must use highly effective contraception from 7 days before the first dose until 6 months after the last dose. A fertile female subject must have a negative serum pregnancy test within 7 days prior to initial dosing.
  • The 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

  • Live virus vaccine (including attenuated live vaccine) was administered within 28 days prior to administration in this study.
  • Patients who received major surgery within 28 days prior to administration of the drug or planned to undergo major surgery during the study period (except for procedures such as puncture or lymph node biopsy).
  • Defined as ≥ Grade 3 pulmonary diseases according to NCI-CTCAE v5.0; Patients with present or history of interstitial lung disease (ILD).
  • Systemic serious infections occurred within 1 week before screening, including but not limited to severe pneumonia caused by fungi, bacteria and viruses, bacteremia or serious infectious complications.
  • Active tuberculosis.
  • People with active autoimmune disease, or a history of autoimmune disease, Including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome, polyvasculitis granulomatosis, autoimmune hepatitis, systemic sclerosing disease, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome), etc. Exceptions include type I diabetes, hypothyroidism stable on hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo that does not require systemic therapy, and B-cell autoimmune disease.
Show all 22Show fewer
  • 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, and those that had been cured and had not recurred within 5 years were excluded.
  • HBsAg positive; HBcAb positive and HBV-DNA detection ≥ lower limit of detection value; HCV antibody positive and HCV-RNA≥ lower limit of detection value; HIV antibody positive.
  • Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg).
  • A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, degree III atrioventricular block, etc.; At rest, the QT interval was prolonged (QTc > 450 msec in men or 470msec in women); Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months prior to initial administration; There is 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.
  • Previous recipients of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
  • Autologous hematopoietic stem cell transplantation (AutoHSCT) was performed within 12 weeks prior to initiation of GNC-038 therapy.
  • Immunosuppressants are being used, including but not limited to: cyclosporine, tacrolimus, etc., within 2 weeks prior to treatment with GNC-038; GNC-038 received high doses of glucocorticoids within 2 weeks prior to treatment (longer than 14 days, daily steady dose \> 30mg of prednisone or equal doses of other corticosteroids), except for patients with R/R ALL, Dexamethasone should be symptomatic when R/R ALL patients have more than 50% bone marrow protocells or peripheral protocells ≥15000/μL during the screening period (see 4.6.2 Availability of drugs during the trial).
  • Received radiotherapy within 4 weeks prior to initiation of GNC-038 treatment.
  • Patients with NHL who had received anti-CD20 or anti-CD79B therapy within 4 weeks before starting GNC-038 therapy continued to respond; ALL patients were treated with TKI, anti-CD19 or anti-CD22 within 4 weeks prior to GNC-038 and still responded, and were treated with bonatumab (CD19×CD3) and izumab - oxomicin (CD22-ADC) within 4 weeks prior to treatment.
  • 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.
  • Other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • Xiangya Hospital Central South University

    Changsha, Hunan

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

  • Shanghai Tongji Hospital

    Shanghai, Shanghai Municipality

  • Hematology Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300000

Other trials in China

About this study

Official title: An Open, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacokinetics, and Antitumor Activity of GNC-038 Quad-specific Antibody Injection in Relapsed or Refractory Non-Hodgkin's Lymphoma, Relapsed or Refractory Acute Lymphoblastic Leukemia, and Refractory or Metastatic Solid Tumors

An open, multicenter, Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics/pharmacokinetics, and antitumor activity of GNC-038 quad-specific antibody injection in relapsed or refractory non-Hodgkin's lymphoma, relapsed or refractory acute lymphoblastic leukemia, and refractory or metastatic solid tumors.

Read the detailed description

Phase Ia: To observe the safety and tolerability of GNC-038 in patients with relapsed or refractory non-Hodgkin lymphoma (R/R NHL)/relapsed or refractory acute lymphoblastic leukemia (R/R ALL), To determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and dose-limiting toxicity (DLT) of GNC-038 without MTD and recommend the dose for subsequent clinical studies. Phase Ib: To further observe the safety and tolerability of GNC-038 at the Phase Ia recommended dose to determine the Phase II recommended dose (RP2D).

Being tested
GNC-038
Medical subject headings
Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma

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 NCT04606433
Study groupRoleWhat they receive
Study treatmentExperimentalThe patients received intravenous infusion of GNC-038 for 1 cycle. After the completion of 2 cycles of treatment, participants with no unbearable ae could proceed to the 3rd and 4th cycles of treatment. After four cycles of treatment, participants with clinical benefits could also receive four additional cycles of the same dose.
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 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 14 days after the first dose

  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 future clinical study

    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 of GNC-038

Secondary outcomes (14)

  1. 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

  2. Cmax: Maximum serum concentration of GNC-038

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

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

  3. Css: Concentration of GNC-038 at steady state plateau

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

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

  4. Tmax: Time to maximum serum concentration (Tmax) of GNC-038

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

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

  5. T1/2: Half-life of GNC-038

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

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

  6. AUC0-inf: Area under the serum concentration-time curve from time 0 to infinity

    Blood concentration - Area under time line.

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

  7. AUC0-t: Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration

    Blood concentration - Area under time line.

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

  8. CL: Clearance in the serum of GNC-038 per unit of time

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

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

  9. 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

  10. Incidence and titer of Nab (Neutralizing antibody)

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

    Measured: Up to approximately 24 months

  11. 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

  12. 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

  13. 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

  14. 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 posted28 Oct 2020
  2. Study start4 Nov 2020
  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
Sequential
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04606433
Sponsor's protocol ID
GNC-038-101
Status last verified
Sep 2025
First submitted
8 Oct 2020
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-038 in people with Non Hodgkin Lymphoma and Acute Lymphoblastic Leukemia, run by Sichuan Baili Pharmaceutical Co., Ltd. at 10 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 15 inclusion and 22 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 10 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?

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 NCT04606433.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in