NCT05623982 A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
| NCT ID | NCT05623982 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sichuan Baili Pharmaceutical Co., Ltd. |
| Condition | Non-hodgkin's Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-09-26 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2022-09-26 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: 1. The subject is capable of understanding the informed consent form, voluntarily participates, and signs the informed consent form; 2. No gender restrictions; 3. Age: ≥18 years and ≤75 years; 4. Expected survival time ≥3 months; 5. Patients with histologically confirmed non-Hodgkin's lymphoma; 6. Patients with relapsed or refractory non-Hodgkin's lymphoma (R/R NHL); 7. 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); 8. ECOG performance status score ≤2; 9. Adverse reactions from prior anti-tumor treatment have recovered to ≤Grade 1 as per CTCAE 5.0 criteria; 10. Organ function levels meet the requirements before the first dose; 11. 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; 12. The subject has the ability and willingness to comply with the study protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures. Exclusion Criteria: 1. Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0; patients currently diagnosed with interstitial lung disease (ILD); 2. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.; 3. Active tuberculosis; 4. Patients with active autoimmune diseases; 5. History of other malignancies within 5 years prior to the first dose; 6. 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; 7. Poorly controlled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg); 8. History of severe cardiovascular or cerebrovascular diseases; 9. Patients with a history of hypersensitivity to recombinant humanized antibodies or any excipients of GNC-038; 10. Pregnant or lactating women; 11. Patients with central nervous system involvement; 12. Major surgery within 28 days before the first dose of this study or planned major surgery during the study period; 13. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); 14. Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before initiating GNC-038 treatment; 15. Current use of immunosuppressive therapy; 16. Radiotherapy within 4 weeks before initiating GNC-038 treatment; 17. Chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives prior to treatment; 18. CAR-T therapy within 12 weeks before initiating GNC-038 treatment; 19. Use of any other investigational drug in a clinical trial within 4 weeks or 5 half-lives before the first dose of this study; 20. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.
Contact & Investigator
Jun Zhu
PRINCIPAL INVESTIGATOR
Peking University Cancer Hospital & Institute
Frequently Asked Questions
Who can join the NCT05623982 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-hodgkin's Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05623982 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05623982 currently recruiting?
Yes, NCT05623982 is actively recruiting participants. Contact the research team at xiaosa@baili-pharm.com for enrollment information.
Where is the NCT05623982 trial being conducted?
This trial is being conducted at Beijing, China, Haerbin, China, Qingdao, China.
Who is sponsoring the NCT05623982 clinical trial?
NCT05623982 is sponsored by Sichuan Baili Pharmaceutical Co., Ltd.. The principal investigator is Jun Zhu at Peking University Cancer Hospital & Institute. The trial plans to enroll 40 participants.