Trial Title:
Phase Ib/II Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
NCT ID:
NCT05623982
Condition:
Non-hodgkin's Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GNC-038
Description:
Administration by intravenous infusion
Arm group label:
Study treatment
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
Detailed description:
phase Ib: To explore the safety and preliminary efficacy of GNC-038 in patients with
relapsed or refractory NHL, and to determine the MTD and RP2Dof GNC-038, or the MAD and
DLT of GNC-038 if MTD is not reached, by intravenous infusion (IV, QW) once a week (2
weeks as a cycle) phase II To explore the efficacy of GNC-038 in patients with relapsed
or refractory non-Hodgkin's lymphoma
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. The subject can understand the informed consent form, voluntarily participate
in and sign the informed consent form;
-
2. Both sexes;
-
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 and refractory non-Hodgkin's lymphoma (R/R NHL).
Specifically include: Patients who have experienced at least a second-line
treatment failure; Investigator-determined patients with relapsed or refractory
non-Hodgkin's lymphoma who had no or were ineligible/intolerant to other
therapies.
-
7. The presence of measurable lesions (any length diameter of lymph node lesions
≥1.5cm or any length diameter of extranodal lesions > 1.0cm) during the
screening period;
-
8. ECOG score ≤2;
-
9. Adverse reactions of previous antitumor therapy returned to CTCAE 5.0 grade ≤1
(except for indicators that the investigator considered to be related to the
disease, such as anemia, and toxicity that the investigator judged to be of no
safety risk, such as hair loss, grade 2 peripheral neurotoxicity, and stable
hypothyroidism after hormone replacement therapy);
-
10. The organ function level before the first administration met the following
requirements: Bone marrow function: In the absence of blood transfusion within
7 days prior to screening, G-CSF (no long-acting white needle within 2 weeks),
and medication correction: Absolute neutrophil count (ANC) ≥1.0×10^9/L
(≥0.5×10^9/L for subjects with bone marrow infiltration); Hemoglobin ≥80 g/L
(≥70g/L for subjects with bone marrow infiltration); Platelet count ≥75×10^9/L;
Liver function: Total bilirubin ≤1.5 ULN (≤3 ULN for Gilbert's syndrome) and
transaminase (AST/ALT) ≤2.5 ULN (≤5.0 ULN for subjects with tumor invasive
changes in the liver) without correction with hepatoprotective agents within 7
days before screening; Kidney function: creatinine (Cr) ≤1.5 ULN and creatinine
clearance (Ccr) ≥50 ml/min (according to Cockcroft and Gault formula);
- Urine routine / 24-hour urinary protein quantification: urine protein
qualitative ≤1+ (if urine protein qualitative ≥2+, 24-hour urinary protein < 1g
can be enrolled);
- Cardiac function: left ventricular ejection fraction ≥50%;
- Coagulation function: fibrinogen ≥1.5g/L; Activated partial thromboplastin time
(APTT) ≤1.5 ULN; Prothrombin time (PT) ≤1.5 ULN.
-
11. Fertile female subjects or male subjects with a fertile partner must use highly
effective contraception from 7 days before the first dose until 12 weeks after
discontinuation of treatment. Fertile female subjects must have a negative
serum/urine pregnancy test within 7 days before the first dose;
-
12. Subjects are able and willing to comply with the study protocol for visits,
treatment plans, laboratory tests, and other study-related procedures.
Exclusion Criteria:
-
1. Pulmonary disease grade ≥3 as defined by 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 pulmonary tuberculosis;
-
4. 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;
-
5. Other malignant tumors were complicated within 5 years before the first
administration, except non-melanoma skin cancer in situ, superficial bladder
cancer, cervical cancer in situ, gastrointestinal intramucosal cancer, breast
cancer, localized prostate cancer that had been cured and had not recurred
within 5 years.
-
6. HBsAg positive or HBcAb positive, and HBV-DNA detection ≥ the lower limit of
the detection value; HCV antibody positive and HCV-RNA≥ lower limit of
detection value; HIV antibody positive;
-
7. Poorly controlled hypertension (systolic blood pressure & GT; 160 mmHg or
diastolic blood pressure & GT; 100 mmHg);
-
8. History of serious cardiovascular and cerebrovascular diseases, including but
not limited to:
- Severe cardiac rhythm or conduction abnormalities, such as ventricular
arrhythmias requiring clinical intervention, degree ⅲ atrioventricular block,
etc.; At rest, the QT interval is prolonged (QTc > 450 msec in men or QTc > 470
msec in women); Acute coronary syndrome, congestive heart failure, aortic
dissection, stroke, or other grade 3 or higher cardiovascular and
cerebrovascular events occurring within 6 months before the first dose;
- The presence of New York Heart Association (NYHA) class II or higher heart
failure;
-
9. Patients with a history of allergy to recombinant humanized antibodies or to
any excipient components of GNC-038;
-
10. Women who are pregnant or breastfeeding;
-
11. Patients with central nervous system invasion;
-
12. Patients who underwent major surgery within 28 days before the administration
of the drug in this study, or who were to undergo major surgery during the
study period (except for puncture or lymph node biopsy);
-
13. Previous organ transplantation or allogeneic hematopoietic stem cell
transplantation (allo-HSCT);
-
14. Autologous hematopoietic stem cell transplantation (Auto-HSCT) was performed
within 12 weeks before starting GNC-038 treatment.
-
15. Pulmonary disease grade ≥3 as defined by NCI-CTCAE V5.0; Patients with current
interstitial lung disease (ILD) (except those who have recovered from previous
interstitial pneumonia);
-
16. Active infections that require systemic treatment, such as severe pneumonia,
bacteremia, sepsis, etc.;
-
17. Active pulmonary tuberculosis;
-
18. 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;
-
19. Other malignant tumors were complicated within 5 years before the first
administration, except non-melanoma skin cancer in situ, superficial bladder
cancer, cervical cancer in situ, gastrointestinal intramucosal cancer, breast
cancer, localized prostate cancer that had been cured and had not recurred
within 5 years.
-
20. HBsAg positive or HBcAb positive, and HBV-DNA detection ≥ the lower limit of
the detection value; HCV antibody positive and HCV-RNA≥ lower limit of
detection value; HIV antibody positive;
-
21. Poorly controlled hypertension (systolic blood pressure & GT; 160 mmHg or
diastolic blood pressure & GT; 100 mmHg);
-
22. A history of serious cardiovascular and cerebrovascular diseases, including but
not limited to:
-
23. Severe cardiac rhythm or conduction abnormalities, such as ventricular
arrhythmias requiring clinical intervention, degree ⅲ atrioventricular block,
etc.;
-
24. At rest, the QT interval was prolonged (QTc > 450 msec in men or QTc > 470 msec
in women).
-
25. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke,
or other grade 3 or higher cardiovascular and cerebrovascular events occurred
within 6 months before the first dose;
-
26. The presence of New York Heart Association (NYHA) heart failure grade II or
higher;
-
27. Patients with a history of allergy to recombinant humanized antibodies or to
any excipient component of GNC-038;
-
28. Women who are pregnant or breastfeeding;
-
29. Patients with central nervous system invasion;
-
30. Patients who underwent major surgery within 28 days before the administration
of the drug in this study, or who were to undergo major surgery during the
study period (except for puncture or lymph node biopsy);
-
31. Previous recipients of organ transplantation or allogeneic hematopoietic stem
cell transplantation (allo-HSCT);
-
32. Autologous hematopoietic stem cell transplantation (Auto-HSCT) was performed
within 12 weeks before starting GNC-038 treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Zhu
Phone:
010-88196115
Email:
zhujun3346@163.com
Contact backup:
Last name:
Yuqin Song
Phone:
010-88196118
Email:
SongYQ_VIP@163.com
Investigator:
Last name:
Jun Zhu
Email:
Principal Investigator
Investigator:
Last name:
Yuqin Song
Email:
Principal Investigator
Facility:
Name:
Harbin First Hospital
Address:
City:
Haerbin
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiguo Wang
Facility:
Name:
Qingdao Central Hospital
Address:
City:
Qingdao
Country:
China
Status:
Recruiting
Contact:
Last name:
Ling Wang
Start date:
September 26, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
SystImmune Inc.
Agency class:
Industry
Collaborator:
Agency:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05623982
