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Recruiting Phase 1, Phase 2 NCT05623982

A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Trial Parameters

Condition Non-hodgkin's Lymphoma
Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2022-09-26
Completion 2026-12
Interventions
GNC-038

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. F

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