Phase
Condition
Leukemia
Non-hodgkin's Lymphoma
Cancer/tumors
Treatment
GNC-038
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The subject is capable of understanding the informed consent form, voluntarilyparticipates, and signs the informed consent form;
No gender restrictions;
Age: ≥18 years and ≤75 years;
Expected survival time ≥3 months;
Patients with histologically confirmed non-Hodgkin's lymphoma;
Patients with relapsed or refractory non-Hodgkin's lymphoma (R/R NHL);
Presence of measurable lesions during the screening period (lymph node lesions withany long diameter ≥1.5 cm or extranodal lesions with any long diameter >1.0 cm);
ECOG performance status score ≤2;
Adverse reactions from prior anti-tumor treatment have recovered to ≤Grade 1 as perCTCAE 5.0 criteria;
Organ function levels meet the requirements before the first dose;
Female subjects of childbearing potential or male subjects with partners ofchildbearing potential must use highly effective contraception from 7 days beforethe first dose until 12 weeks after treatment discontinuation. Female subjects ofchildbearing potential must have a negative serum/urine pregnancy test within 7 daysbefore the first dose;
The subject has the ability and willingness to comply with the studyprotocol-specified visits, treatment plans, laboratory tests, and otherstudy-related procedures.
Exclusion
Exclusion Criteria:
Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0; patientscurrently diagnosed with interstitial lung disease (ILD);
Active infections requiring systemic treatment, such as severe pneumonia,bacteremia, sepsis, etc.;
Active tuberculosis;
Patients with active autoimmune diseases;
History of other malignancies within 5 years prior to the first dose;
HBsAg-positive and/or HBcAb-positive with HBV-DNA levels ≥ the lower limit ofdetection; HCV antibody-positive with HCV-RNA levels ≥ the lower limit of detection;HIV antibody-positive;
Poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic bloodpressure >100 mmHg);
History of severe cardiovascular or cerebrovascular diseases;
Patients with a history of hypersensitivity to recombinant humanized antibodies orany excipients of GNC-038;
Pregnant or lactating women;
Patients with central nervous system involvement;
Major surgery within 28 days before the first dose of this study or planned majorsurgery during the study period;
Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeksbefore initiating GNC-038 treatment;
Current use of immunosuppressive therapy;
Radiotherapy within 4 weeks before initiating GNC-038 treatment;
Chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives priorto treatment;
CAR-T therapy within 12 weeks before initiating GNC-038 treatment;
Use of any other investigational drug in a clinical trial within 4 weeks or 5half-lives before the first dose of this study;
Any other condition deemed unsuitable for participation in this clinical trial bythe investigator.
Study Design
Study Description
Connect with a study center
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaSite Not Available
Beijing Cancer Hospital
Beijing 1816670, Beijing Municipality 2038349 100142
ChinaActive - Recruiting
Harbin First Hospital
Haerbin, Heilongjing
ChinaActive - Recruiting
Qingdao Central Hospital
Qingdao, Shandong
ChinaSite Not Available
Qingdao Central Hospital
Qingdao 1797929, Shandong 1796328
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.