None listed
Conditions
Interventions
Drug : This clinical trial is divided into two parts, with Part A followed by Part B sequentially.
Part A (Safety run-in): Through the evaluation of the tolerability of GI-102 administration, the sele
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult men and women aged 19 years or older 2. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) according to the 2017 WHO classification 3. Relapsed or refractory DLBCL after at least two prior systemic therapies 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2 5. Adequate hematologic, renal, hepatic, pulmonary, cardiac, and bone marrow function confirmed within 2 weeks prior to screening. For patients who agree to participate in this clinical trial after receiving CAR T-cell therapy, eligibility may be determined based on results from the institution’s local laboratory tests conducted within 2 weeks of the CAR T-cell infusion date. A. Hematologic function: i. Absolute neutrophil count (ANC) = 1,000/µL ii. Platelet count = 75,000/µL B. Renal function: Estimated glomerular filtration rate (eGFR) (based on CKD-EPI) = 40 mL/min/1.73m² C. Hepatic function: i. AST and ALT = 3 × upper limit of normal (ULN) (= 5 × ULN if liver metastases are present) ii. Total bilirubin = 2.0 mg/dL (= 3.0 × ULN for individuals with Gilbert’s syndrome, and direct bilirubin = 1.5 × ULN) D. Cardiac function: Left ventricular ejection fraction (LVEF) = 40% as confirmed by echocardiogram (ECHO) or MUGA scan 6. Life expectancy of at least 12 weeks 7. For women of childbearing potential, a negative serum or urine hCG pregnancy test during screening and throughout the study period 8. Voluntarily agreed to participate in the clinical trial and provided written informed consent 9. At the time of informed consent, the subject must have previously received or be scheduled to receive anti-CD19 CAR-T cell therapy prior to administration of GI-102. Administration of anti-CD19 CAR-T therapy is required before receiving GI-102.
Exclusion criteria
Exclusion criteria: 1) Individuals with a history of prior allogeneic hematopoietic stem cell transplantation (allo-HSCT). 2) Individuals with the following comorbidities that may impact safety and efficacy evaluation during the clinical trial period, as determined by the investigator: A. Severe infections or other active infectious diseases requiring systemic antibiotics or antiviral agents during the clinical trial period, which may impact safety and efficacy evaluation. B. Conditions requiring corticosteroid therapy or autoimmune diseases (except for physiologic corticosteroid replacement therapy). C. Other uncontrolled or clinically significant comorbidities that would deem participation in the clinical trial inappropriate. 3) Individuals with the following medical history at the screening visit: A. Clinically significant cardiac disorders within 6 months before screening, including unstable angina, myocardial infarction, cardiac angioplasty, stent placement, or other clinically significant cardiac conditions. B. Clinically significant thromboembolic disease, pulmonary embolism, or bleeding diatheses within 6 months before screening. C. Major surgery within 4 weeks before screening. 4) Pregnant or lactating individuals. 5) Women of childbearing potential or men who are unwilling to use effective contraception during the clinical trial period, including the 12 months following anti-CD19 CAR T-cell therapy. A. Fertile women are defined as those who have experienced menstruation and do not meet any of the following criteria: i. Postmenopausal status (defined as no menses for at least 12 months without any other pathologic or physiologic cause and confirmed by follicle-stimulating hormone (FSH) levels = 40 IU/L at screening). ii. Undergone hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion. iii. Clinically confirmed congenital or acquired ovarian insufficiency preventing pregnancy. B. Men with azoospermia (defined as having undergone vasectomy for at least 1 year or due to underlying medical conditions) are considered infertile. C. Effective contraception is defined as follows†: i. Single method (any one of the following is acceptable): - Intrauterine device (IUD). - Vasectomized male partner of female trial subjects. - Contraceptive implant. ii. Dual methods (any two of the following are required): - Barrier methods containing spermicide (cannot be used with cervical cap/spermicide). - Cervical cap with spermicide (applicable to nulliparous women only). - Contraceptive sponge (applicable to nulliparous women only). - Male condoms or female condoms (cannot be used together). - Hormonal contraceptives: Oral contraceptive pills (combination estrogen/progestin pills or progestin-only pills), transdermal contraceptive patch, vaginal contraceptive ring, or subcutaneous contraceptive injection. If local regulations/guidelines restrict the listed contraceptive methods, they are not considered acceptable contraception for trial subjects at the participating trial sites in that country/region. iii. All other female trial subjects (including those with tubal ligation) are considered at risk of pregnancy. All male trial subjects engaging in sexual activity must agree to consistently and correctly use condoms throughout the entire period of the tr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pharmacokinetic (PK) profiles of CAR T cells | — |
Secondary
| Measure | Time frame |
|---|---|
| preliminary efficacy;Safety and tolerability;Analysis of pharmacodynamics (PD), pharmacogenomics, and other biomarkers (blood, tumor tissue) | — |
Countries
Korea, Republic of
Contacts
Public ContactNa Eun Lee
Asan Medical Center
Outcome results
None listed