Status:
UNKNOWN
Mechanism of Resistance to GNC-038 in Relapsed and Refractory Diffuse Large B-cell Lymphoma
Lead Sponsor:
Ruijin Hospital
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18-80 years
Brief Summary
This is an exploratory study embedded in the Phase Ib/II clinical trial of CD3 x 4-1BB x CD19 x PD-L1 tetra-specific T cell engager GNC-038 in relapsed and refractory diffuse large B-cell lymphoma ini...
Eligibility Criteria
Inclusion
- For Group 1, the selection criteria are firstly concordant with those of the corresponding clinical trial. On this basis, additional selection criteria for this study are:
- Lymph node lesions with long diameter ≥ 2cm.
- Subjects have the ability and willingness to follow the visit, biosample collection and other research-related processes prescribed by the research program and to sign informed consent forms.
- For Group 2, the selection criteria are:
- The subject is able to understand the informed consent form, and voluntarily participates and signs the informed consent form;
- Age between 18 and 80;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 points.
Exclusion
- For Group 1, the exclusion criteria are totally concordant with those of the corresponding clinical trial. There is no additional exclusion criteria for this study.
- For Group 2, the exclusion criteria are:
- History of past or present malignant diseases;
- Patients with active autoimmune diseases, or patients with a history of autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's granulomatosis, polyvascular inflammation granuloma, Grave's disease, rheumatoid arthritis, pituitary inflammation, ophthalmic pigmentitis, autoimmune hepatitis, systemic sclerosis, Hashimoto thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain- Barre syndrome), etc.;
- Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection (HBsAg-positive or HBcAb-positive, HBV-DNA test positive), hepatitis C virus infection (HCV antibody-positive and HCV-RNA test positive), EB virus infection (EBV-DNA test positive), cytomegalovirus infection (CMV-DNA test positive) or herpes simplex virus infection (HSV-DNA test positive);
- Pregnant or nursing women;
- Previous organ transplants or allogeneic hematopoietic stem cell transplants;
- Under treatment of immunosuppressants, including but not limited to cyclosporine, tacrolimus, corticosteroids, etc., within 1 month prior to sampling;
- Fever (temperature \>37.5 ℃) within 1 month prior to sampling, or using antibiotics due to respiratory, gastrointestinal, urinary tract infections, etc.;
- Other situations in which the researchers consider it inappropriate for the patient to participate in this study.
Key Trial Info
Start Date :
August 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05189782
Start Date
August 10 2022
End Date
September 1 2024
Last Update
August 31 2022
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025