It is a treatment that activates and strengthens the immune system against cancer. Recently, T cell receptors have been genetically rearranged by adaptive T cell therapies, which are promising in the fight against cancer, and are now able to recognize antigens on tumor cells. These modified T cell receptors are called chimeric antigen receptors. Many previous clinical studies have shown that different CAR-T cells are effective in relapse / refractory B cell cancers and NHL.
Clinical trials of CAR-T cell therapy started at the end of 1990s. Phase I and II trials have still evaluated the efficacy and safety of CAR-T cells in hematological and solid cancers. The therapy involves drawing blood from patients and isolation of the T cells. Next, the T cells are genetically engineered in a laboratory by using virus or sleeping beauty to produce receptors on their surface named as chimeric antigen receptors. As the last step, the CAR-T cells are infused back into the patient. After infusion, it is expected that the CAR-T cells further increase in number in the patient's body and with the help of their engineered receptor to recognize and target the antigen on the surface of the cancerous cells for antitumor effect.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Lymphodepletion Protocol: * -6. Day: Cyclophosphamide 300 mg / m\^2 i.v. * -5. -4. and -3. Days: Fludarabine 30 mg / m\^2 i.v. In addition, one day before the lymphodepletion protocol, xanthine oxidase enzyme inhibitor tablets received 100 mg / day p.o. and 0.9% sodium chloride solution 2000 ml / day i.v. infusion on protocol day received and continues for 2 weeks Car-T cells are administered in 3 split doses. Day 0: 20% or 40% (20% in patients with high tumor burden - in patients with bulky disease and / or more than 15% blast in bone marrow, 40% in patients with low tumor burden) Day 2: 30% or 50%, (the total amount of Car-T cell dose that should be given in the first 2 days should be 70%.) Third dose (%30);is given on the 7th day in the absence of cytokine release syndrome, or if cytokine release syndrome occurs, Car-T cells are given within 1 month if the number of copies falls below 5,000 / ml in 2 consecutive measurements.
Acıbadem Labcell Cellular Therapy Laboratories
Istanbul, Turkey (Türkiye)
RECRUITINGIncidence of Adverse Events
Type, frequency and severity of adverse events (AEs) and laboratory abnormalities.
Time frame: 6 Months
Complete Remission Rate
It is determined by the evaluation of complete remission (CR) obtained in the first 3 months.
Time frame: 3 Months
Total Response Rate
CR obtained in the first 3 months is determined by evaluation of partial remission, incomplete partial remission and stable disease responses.
Time frame: 3 Months
Duration of Remission (DOR)
Duration of remission (DOR) is defined as the duration from the date when the response criteria of CR or CRi is first met to the date of relapse or death due to underlying cancer, whichever occurs first.
Time frame: 6 Months
Relapse Free Survival (RFS)
Relapse free survival (RFS) is measured by the time from achievement of CR or CRi whatever occurs first to relapse or death due to any cause during CR or CRi.
Time frame: 6 Months
Progression Free Survival
Only in the NHL is the duration from CAR T cell infusion to progression
Time frame: 6 Months
Event-Free Survival (EFS)
Event free survival (EFS) is the time from date of first Car-T cell infusion to the earliest of the following: * Death from any cause * Relapse
Time frame: 6 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Overall Survival
Overall survival (OS) is the time from date of first Car-T Cell infusion to the date of death due to any reason.
Time frame: 6 Months
Duration to maximum response
The duration from date of the first Car-T cell infusion to complete remission in ALL. The duration from date of the first Car-T cell infusion to complete remission and partial remission in NHL
Time frame: 6 Months
The impact of baseline tumor burden on response
Best overall response will be summarized by baseline tumor burden (MRD, extramedullary disease, etc.)
Time frame: 6 Months
The relationship between CRS/CRES efficiency
The relationship between CRS / CRES grades and total response rates are determined by correlation between DOR, RFS, EFS, PFS, OS.
Time frame: 6 Months
The relationship between the total response and Car-T Cell persistence
The relationship between total response and the number of Car-T copies is determined by the correlation between DOR, RFS, EFS, PFS, OS
Time frame: 6 Months
The relationship between Car-T Cell product content and responses
The relationship between Car-T Cell subgroups and total response are determined by the correlation between DOR, RFS, EFS, PFS, OS.
Time frame: 6 Months
Car-T cell proliferation capability
The relationship between the Car-T Cell proliferation capability and the total response, are determined by the correlation between DOR, RFS, EFS, PFS, OS.
Time frame: 6 months
The relationship between MRD grade and clinical response
The relationship between MRD grade and total response are determined by correlation between DOR, RFS, EFS, PFS, OS.
Time frame: 6 Months
The relationship between the incidence of immune response to Car-T cells and the persistence of Car-T cell
It is assessed as the relationship between antiserum effectivity against Car-T cells and Car-T cell copy number in blood.
Time frame: 6 Months