Primary Central Nervous System LymphomaPhase 1/2NCT05485753

A Study of GNC-038, a Tetra-specific Antibody, in Patients With Central Nervous System Lymphoma (PCNSL) and Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL)

A Phase 1/2 study testing GNC-038 in people with Primary Central Nervous System Lymphoma and Secondary Central Nervous System 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

Search all trials

Trial summary

In this study, the safety and preliminary efficacy of GNC-038 in patients with r relapsed or refractory primary central nervous system lymphoma (PCNSL) and relapsed or refractory secondary central nervous system lymphoma (SCNSL) will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Primary Central Nervous System Lymphoma, Secondary Central Nervous System 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: 7 participants
Where: 4 sitesChina
Study dates: 10 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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1. The subject can understand the informed consent, participate in and sign the informed consent voluntarily;
2. No gender limitation;
3. Age: ≥18;
4. Expected survival time ≥3 months;
5. Patients with primary CNS lymphoma (PCNSL) and secondary CNS lymphoma (SCNSL) confirmed by histology or cytology;
6. A. Patients with recurrent/refractory primary central nervous system lymphoma (PCNSL) and recurrent/refractory secondary central nervous system lymphoma (SCNSL) may be associated with ocular lymphoma;B. Patients with relapsed or refractory primary CNS lymphoma (PCNSL) and relapsed or refractory secondary CNS lymphoma (SCNSL) who were not eligible or intolerant to other therapies were determined by the investigator;Recurrence and refractory are defined as follows: Recurrence refers to the emergence of new lesions after adequate treatment to complete response (CR).Refractory refers to a patient who has experienced at least first-line treatment without disease remission, e.g. induction chemotherapy with methotrexate without CR.

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7. KPS score ≥60;
8. Adverse reactions of previous antitumor therapy returned to CTCAE 5.0 grade ≤1 (except for the indicators that the researchers considered to be related to the disease, such as anemia, and toxicities that the researchers determined to be without safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.);
9. Before the first administration, the organ function level should meet the following requirements:
Bone marrow function: In the absence of blood transfusion, G-CSF (long-acting white needle within 2 weeks) and medication correction within 7 days prior to screening:
Absolute neutrophil count (ANC) ≥15×10^9/L (subjects with bone marrow infiltration should be ≥0.5×10^9/L);Hemoglobin ≥90 g/L;Platelet count ≥90×10^9/L; Liver function: Total bilirubin ≤1.5 ULN (Gilbert's syndrome ≤3 ULN), transaminase (AST/ALT) ≤2.5 ULN (≤5.0 ULN for subjects with tumor invasive changes in the liver) without correction with hepatoprotective drugs within 7 days prior to screening; Renal function: Creatinine (Cr) ≤1.5 ULN and creatinine clearance (Ccr) ≥50 mL /min according to the Cockcroft and Gault formula; Routine urine / 24-hour urine protein quantification: qualitative urine protein ≤1+ (if qualitative urine protein ≥2+, 24-hour urine protein < 1g can be included); 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.
10. Fertile female subjects or male subjects with fertile partners must use highly effective contraception beginning 7 days before the first dose and up to 12 weeks after the last dose. Fertile female subjects must have a negative serum/urine pregnancy test within 7 days prior to initial dosing;
11. The subject is able and willing to follow the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.

Who cannot join

1. Lung disease defined as grade ≥3 according to NCI-CTCAE V5.0; Patients with current interstitial lung disease (ILD) (except those who have recovered from previous interstitial pneumonia);
2. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
3. Active tuberculosis;
4. Brain stem tumor infiltration or only eye lesions;
5. Patients with 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 (e.g., vitiligo, psoriasis), B cells caused by autoimmune disease;
6. Non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal cancer, breast cancer, localized prostate cancer and other cancers that have been cured and have not recurred within 5 years prior to the first administration are excluded;

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7. HBsAg positive or HBcAb positive, and HBV-DNA test ≥ the upper limit of normal; HCV antibody positive and HCV-RNA≥ the upper limit of normal value; HIV antibody positive;
8. Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg);
9. Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to: Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias and degree ⅲ ATrioventricular block requiring clinical intervention; Longer QT interval at rest (QTc > 450 msec for men or 470 msec for 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 first administration; Heart failure with the New York Heart Association (NYHA) Heart function rating ≥II; 10. Patients with a history of allergy to recombinant humanized antibodies or to any excipient ingredient of GNC-038;
11. Pregnant or breastfeeding women;
12. Patients who cannot tolerate MRI examination;
13. Patients who underwent major surgery within 28 days prior to administration of the drug in this study, or who planned to undergo major surgery during the study period (except for puncture or biopsy surgery);
14. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (ALLO-HSCT);
15. Autologous hematopoietic stem cell transplantation (AUTO-HSCT) within 12 weeks prior to initiation of GNC-038 therapy;
16. Immunosuppressants are being used, including but not limited to: Cyclosporine, tacrolimus, etc. within 2 weeks prior to gnC-038 treatment; Gnc-038 received a high dose of glucocorticoid for 2 weeks prior to treatment (longer than 14 days, a steady dose of dexamethasone >5mg per day or equivalent dose of other glucocorticoids);
17. Received radiotherapy within 4 weeks prior to initiation of GNC-038 treatment;
18. Received anti-CD20 or anti-CD79B treatment within 4 weeks prior to initiation of GNC-038 and still responded;
19. Received chemotherapy and small molecule targeted therapy within 2 weeks prior to treatment;
20. Received CAR-T therapy within 12 weeks prior to initiation of GNC-038;
21. Participated in any other clinical trials within 4 weeks prior to administration of this trial;
22. Past or present central nervous system disease, including, but not limited to, stroke (imaging)
23. Medical examination indicated "lacunar cerebral infarction" except those requiring no treatment), severe brain injury, Senile dementia, Parkinson's disease, organic brain syndrome, psychosis;
24. Other conditions that the investigator considers inappropriate for participation in this clinical trial.

Trial locations and contacts

4 sites in 1 country.

China4 sites

Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Beijing GoBroad Boren Hospital
Beijing, Beijing Municipality
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan

Other trials in China

About this study

Official title: An Open, Multicenter, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of Tetra-specific Antibody GNC-038 Injection in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL)

Conditions: Primary Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma
Being tested: GNC-038

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 NCT05485753
Study group	Role	What they receive
Study treatment	Experimental	Participants 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.

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 17 days after the first dose
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 17 days after the first dose
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 36 months
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 17 days after the first dose

Secondary outcomes (14)

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 36 months
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 36 months
DCR (Disease Control Rate)
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 36 months
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 36 months
CR (Complete Response)
Disappearance of all target lesions.
Measured: Up to approximately 36 months
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 36 months
Peak Plasma Concentration（Cmax)
Maximum serum concentration (Cmax) of GNC-038 will be investigated.
Measured: Up to 17 days after the first dose
Incidence and titer of ADA (Anti-drug antibody)
Frequency and titer of anti-GNC-038 antibody (ADA) will be evaluated.
Measured: :Up to approximately 36 months
Incidence and titer of Nab
Incidence and titer of Nab of GNC-038 will be evaluated.
Measured: Up to approximately 36months
Time to reach maximum concentration (Tmax)
Time to maximum serum concentration (Tmax) of GNC-038 will be investigated.
Measured: Up to 17 days after the first dose
AUC0-inf
Area under the plasma concentration-time curve from time 0 extrapolated to infinite (AUC0-inf).
Measured: Up to 17 days after the first dose
AUC0-t
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t).
Measured: Up to 14 days after the first dose of GNC-038
Plasma clearance （CL）
To study the serum clearance rate of GNC-038 per unit time.
Measured: Up to 17 days after the first dose
Elimination half life （T1/2）
Blood concentration - Area under time line.
Measured: Up to 17 days after the first dose

Timeline

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

10 Feb 2023Dec 2025

First posted3 Aug 2022
Study start10 Feb 2023
Primary completionDec 2025 (estimated)
Study completionDec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary Central Nervous System LymphomaStudies of the same condition, open and under way.
More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05485753
Sponsor's protocol ID: GNC-038-103
Status last verified: Sep 2025
First submitted: 31 Jul 2022
Last updated: 26 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Primary Central Nervous System Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open, Multicenter, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of Tetra-specific Antibody GNC-038 Injection in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL)
ClinicalTrials.gov ID: NCT05485753
Acronym / sponsor ID: GNC-038-103
Conditions: Primary Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 7 participants (actual)
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: SystImmune Inc., Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Study start: 10 Feb 2023 (actual)
Primary completion: Dec 2025 (estimated)
Study completion: Dec 2025 (estimated)
First posted: 3 Aug 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study treatment	Experimental	Drug: GNC-038Participants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

1. The subject can understand the informed consent, participate in and sign the informed consent voluntarily;
2. No gender limitation;
3. Age: ≥18;
4. Expected survival time ≥3 months;
5. Patients with primary CNS lymphoma (PCNSL) and secondary CNS lymphoma (SCNSL) confirmed by histology or cytology;

Key exclusion criteria (23 listed)

1. Lung disease defined as grade ≥3 according to NCI-CTCAE V5.0; Patients with current interstitial lung disease (ILD) (except those who have recovered from previous interstitial pneumonia);
2. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
3. Active tuberculosis;
4. Brain stem tumor infiltration or only eye lesions;
5. Patients with 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 (e.g., vitiligo, psoriasis), B cells caused by autoimmune disease;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GNC-038Administration by intravenous infusion	Drug	Study treatment

Primary outcome

Dose limiting toxicity (DLT)
Time frame: Up to 17 days after the first dose
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).
Maximum tolerated dose (MTD) or maximum administrated dose (MAD)
Time frame: Up to 17 days after the first dose
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.
Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to approximately 36 months
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.
The recommended dose for phase II clinical study（RP2D）
Time frame: Up to 17 days after the first dose
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.

14 secondary outcomes

ORR (Objective Response Rate )
Time frame: Up to approximately 36 months
PFS (Progression-free Survival)
Time frame: Up to approximately 36 months
DCR (Disease Control Rate)
Time frame: Up to approximately 36 months
DOR (Duration of Response)
Time frame: Up to approximately 36 months
CR (Complete Response)
Time frame: Up to approximately 36 months
Adverse Events of special interest (AESI)
Time frame: Up to approximately 36 months
Peak Plasma Concentration（Cmax)
Time frame: Up to 17 days after the first dose
Incidence and titer of ADA (Anti-drug antibody)
Time frame: :Up to approximately 36 months
Incidence and titer of Nab
Time frame: Up to approximately 36months
Time to reach maximum concentration (Tmax)
Time frame: Up to 17 days after the first dose
AUC0-inf
Time frame: Up to 17 days after the first dose
AUC0-t
Time frame: Up to 14 days after the first dose of GNC-038
Plasma clearance （CL）
Time frame: Up to 17 days after the first dose
Elimination half life （T1/2）
Time frame: Up to 17 days after the first dose

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
Individual participant dataSharing planned: No

Related trials for Primary Central Nervous System Lymphoma

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wenbin Li principal investigator

Beijing Tiantan Hospital

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 inclusion and 23 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 17 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 NCT05485753.

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.