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New treatment option for Non-hodgkin's Lymphoma
Official title A Study of GNC-035 in Relapsed or Refractory Non-Hodgkin 's Lymphoma and Other Hematological Malignancies
ClinicalTrials.gov ID: NCT06066203
What this study is testing
What is GNC-035?
GNC-035 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for non-hodgkin's lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase I main objectives: To observe the safety and preliminary efficacy of GNC-035 in patients with relapsed/refractory non-Hodgkin lymphoma and other hematological malignancies, to determine the DLT and MTD, or MAD, and to determine RP2D. Phase II Main objective: To explore the efficacy of GNC-035 in patients with relapsed/refractory non-Hodgkin lymphoma and other hematological malignancies.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The subject is able to understand the informed consent form, voluntarily participates, and signs the informed consent form;
- No gender restrictions;
- Age: ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Histologically or cytologically confirmed relapsed or refractory non-Hodgkin's lymphoma;
You likely can't join if
- Patients who have undergone major surgery within 28 days prior to the administration of this study or are scheduled for major surgery during the...
- Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0;
- Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
- Patients with active autoimmune diseases;
- History of other malignancies within 5 years prior to the first dose;
- Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV)...
See the full eligibility criteria
- The subject is able to understand the informed consent form, voluntarily participates, and signs the informed consent form;
- No gender restrictions;
- Age: ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Histologically or cytologically confirmed relapsed or refractory non-Hodgkin's lymphoma;
- For patients with relapsed or refractory non-Hodgkin's lymphoma, specifically including: Patients who have failed at least one line of standard therapy; Patients with relapsed or refractory disease judged by the...
- For non-Hodgkin's lymphoma, at least one measurable lesion meeting the Lugano response criteria must be present during the screening period;
- ECOG performance status score ≤2;
- Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- Organ function levels meet the requirements within 7 days before the first dose;
- Female people of childbearing potential or male people with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 12 weeks after the last dose. Female people...
- The subject has the ability and willingness to comply with the study protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.
- Patients who have undergone major surgery within 28 days prior to the administration of this study or are scheduled for major surgery during the study period (major surgery is defined by the investigator);
- Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0;
- Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
- Patients with active autoimmune diseases;
- History of other malignancies within 5 years prior to the first dose;
- Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection;
- Poorly controlled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg) despite medication;
- History of severe cardiovascular or cerebrovascular diseases;
- Patients with a history of hypersensitivity to recombinant humanized antibodies or any excipients of GNC-035;
- Pregnant or lactating women;
- Patients with central nervous system involvement;
- Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
- Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before initiating GNC-035 treatment;
- Current use of immunosuppressive therapy;
- Radiotherapy or macromolecular targeted therapy within 4 weeks before initiating GNC-035 treatment; chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives (whichever is shorter) before treatment;
- Anti-CD20 or anti-CD79b treatment within 4 weeks before initiating GNC-035 treatment with ongoing response;
- CAR-T therapy within 12 weeks before initiating GNC-035 treatment;
- Use of investigational drugs from other clinical trials within 4 weeks or 5 half-lives (whichever is shorter) before the administration of this study;
- Any other condition deemed unsuitable for participation in this clinical trial by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.