Trial Title:
A Study of GNC-038 Injection in Patients With Relapsed or Refractory NK/ T-cell Lymphoma, AITL, and Other NHL
NCT ID:
NCT05627856
Condition:
NK/T Cell Lymphoma
Vascular Immunomother T Cell Lymphoma
Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
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 efficacy of GNC-038 in relapsed or refractory NK/T cell
lymphoma, vascular immunomother T cell lymphoma, and other relapsed or refractory NHL,
and to determine MTD, MAD, DLT, and RP2D of GNC-038, as well as its pharmacokinetic
characteristics and immunogenicity.
Detailed description:
Phase Ib: To explore the safety and preliminary effectiveness of GNC-038 under the
administration mode of "intravenous infusion for 2h to 4h, once a week (IV, QW), 2 weeks
as one cycle", and to determine MTD, MAD, DLT and RP2D of GNC-038. The pharmacokinetic
characteristics and immunogenicity of GNC-038 will be evaluated. Phase II: To explore the
efficacy, safety and tolerability, pharmacokinetic characteristics and immunogenicity of
GNC-038.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects can understand the informed consent, voluntarily participate in and sign
the informed consent.
2. No gender restriction.
3. Age: ≥18 and ≤75 years old.
4. Expected survival time ≥3 months.
5. Patients with histologically confirmed NK/T cell lymphoma or vascular immunomother T
cell lymphoma.
6. Patients with relapsed/refractory NK/T cell lymphoma (R/R NKTCL) or
relapsed/refractory vascular immunomother T cell lymphoma (AITL):
1) Patients with recurrent or refractory vascular immunomother T cell lymphoma after
initial treatment.
2) Patients with NK/T cell lymphoma need to have received systematic therapy with
asparaginase regimen in the past, and have received radiotherapy for single lesion
recurrence or refractory treatment.
Difficult-to-treat definition: i) the curative effect of end-line treatment did not reach
PR; Or ii) disease progression within 6 months after terminal line treatment.
7. In the screening period, there were measurable lesions (lymph node lesions with any
length ≥1.5cm or exodal lesions with any length > 1.0cm, all of which had metabolic
activity).
8. Physical status score ECOG ≤2 points. 9. The adverse reactions of previous antitumor
therapy were restored to CTCAE level 5.0 evaluation ≤ level 1 (except for indicators
that the researchers considered might be related to the disease, such as anemia, and
toxicities that the researchers judged to have no safety risk, such as hair loss,
grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement
therapy, etc.).
10. Organ function level before initial administration meets the following requirements:
Bone marrow function: without blood transfusion within 7 days prior to screening,
without G-CSF (without long-acting rising white needle within 2 weeks) and drug
correction: Absolute neutrophil count (ANC) ≥1.0×109/L (≥0.5×109/L for subjects with
bone marrow infiltration); Hemoglobin ≥80 g/L (≥70g/L for subjects with bone marrow
infiltration); Platelet count ≥75×109/L; Liver function: total bilirubin ≤1.5 ULN
(Gilbert's syndrome ≤3 ULN), transaminase (AST/ALT) ≤2.5 ULN (subjects with liver
tumor invasive changes ≤5.0 ULN) within 7 days before screening without liver
protection drugs; Renal function: creatinine (Cr) ≤1.5 ULN and creatinine clearance
(Ccr) ≥50 ml/min (according to Cockcroft and Gault formula); Urine routine /24 hours
urine protein quantification: qualitative urine protein ≤1+ (if qualitative urine
protein ≥2+, 24 hours urine protein < 1g can be included in the group); Cardiac
function: left ventricular ejection fraction ≥50%; Coagulation function: fibrinogen
≥1.5g/L; Activated partial thrombin time (APTT) ≤1.5 ULN; Prothrombin time (PT) ≤1.5
ULN.
11. Fertile female subjects or fertile male subjects with partners must use highly
effective contraception from 7 days prior to the first dose until 12 weeks after
termination of treatment. A fertile female subject must have a negative serum/urine
pregnancy test within 7 days prior to initial dosing.
12. Subject is able and willing to comply with visits, treatment plans, laboratory
tests, and other study-related procedures as specified in the study protocol.
Exclusion Criteria:
1. According to NCI-CTCAE v5.0, it was defined as ≥ grade 3 pulmonary disease; Patients
who currently have interstitial lung disease (ILD) (except those who previously had
interstitial pneumonia and have recovered).
2. Active infections requiring systemic treatment, such as severe pneumonia,
bacteremia, sepsis, etc.
3. Active tuberculosis.
4. Patients with hemophagocytic syndrome.
5. Patients with lesions invading pulmonary great vessels.
6. Active patients with 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.
7. Non-melanoma skin cancer in situ, superficial bladder cancer in situ, cervical
cancer in situ, gastrointestinal intramucosal cancer, breast cancer, localized
prostate cancer and other malignant tumors that were combined with other malignant
tumors within 5 years prior to the first administration of the drug, except those
that the researchers thought could be included.
8. HBsAg positive or HBcAb positive, and HBV-DNA detection ≥ detection value lower
limit (HBV-DNA detection in the normal range and regular use of anti-HBV drugs
except patients); HCV antibody was positive and HCV-RNA≥ lower limit of detection
value.
9. Poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic
blood pressure >100 mmHg).
10. A history of severe cardiovascular and cerebrovascular diseases, including but not
limited to:
Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias
and degree III atrioventricular block that require clinical intervention; Prolonged
QT interval at rest (QTc > 450 msec in men or 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 prior to
initial administration; Present with heart failure ≥II on the New York Heart
Association (NYHA) cardiac function scale.
11. Patients with a history of allergy to recombinant humanized antibodies or to any
excipient component of GNC-038.
12. Pregnant or breastfeeding women.
13. Patients with central nervous system invasion.
14. Patients who received major surgery within 28 days prior to drug administration in
this study, or planned to undergo major surgery during the study period (except for
procedures such as puncture or lymph node biopsy).
15. Previous recipients of organ transplantation or allogeneic hematopoietic stem cell
transplantation (Allo-HSCT).
16. Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 24 weeks
before starting GNC-038 therapy.
17. Immunosuppressants are being used, including, but not limited to, cyclosporine,
tacrolimus, etc. within 2 weeks prior to treatment with GNC-038.
18. Radiotherapy was received within 4 weeks prior to the initiation of GNC-038 therapy.
19. Received chemotherapy and small molecule targeted therapy within 2 weeks prior to
treatment.
20. Received CAR-T therapy within 12 weeks prior to initiation of GNC-038 therapy.
21. Participants in any other clinical trial within 4 weeks prior to administration of
this trial.
22. A history of immunodeficiency, including HIV positive testing, or other acquired,
congenital immunodeficiency diseases.
23. Other conditions deemed unsuitable for participation in this clinical trial by the
investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510050
Country:
China
Status:
Recruiting
Contact:
Last name:
Huiqiang Huang
Phone:
020-87343350
Email:
huang_sysu@163.com
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenyu Li, PHD
Phone:
02081884713
Email:
liwy1206@163.com
Start date:
February 21, 2023
Completion date:
February 2025
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/NCT05627856
