B-cell Acute Lymphoblastic Leukemia
Conditions
Keywords
CT119X
Brief summary
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT119X(including CT1190-P and CT1192) CAR-T Cell therapy, in Patients with Relapsed/Refractory B-cell acute lymphoblastic leukemia.
Detailed description
This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT119X (including CT1190-P and CT1192)cells in patients with B-ALL. It is planned to enroll 6-36participants.
Interventions
chimeric antigen receptor T cells
Sponsors
Shanghai Tongji Hospital, Tongji University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Participants must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the study visit schedule and other protocol requirements 2. 18-75 years old; 3. Histologically or cytologically confirmed B-ALL; 4. Previously received at least 2 lines of systemic therapy; 5. Expected survival \> 12 weeks; 6. Eastern Cooperative Oncology Group (ECOG) score 0-2; 7. Female participants of childbearing potential must have a negative pregnancy test at screening and prior to receiving preconditioning therapy。Both male and Female are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating sperm donation or eggs for 1 year after receiving study treatment infusion during the study.
Exclusion criteria
1. Pregnant or lactating women; 2. Has HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis Cvirus infection (HCV antibody and HCV-DNA positive); 3. Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment); 4. Participants' toxicities caused by previous treatment did not recover to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade1, except alopecia and other events that are judged tolerable by the investigator; 5. Patients with isolated extramedullary lesions; 6. Vaccination with live attenuated vaccines, inactivate vaccines or RNA vaccines within 4 weeks prior to informed consent; 7. Participants who are allergic or intolerant to preconditioning drugs, tocilizumab, or have other previous history of severe allergy such as anaphylactic shock; 8. Patients with heart disease in the 6 months prior to screening; 9. Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years; 10. Serious pulmonary diseases that are judged by the investigator to potentially endanger the patient's life when participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MTD and/or dose range | Up to 28 days after CAR-T cells infusion | Evaluate Dose limited toxicity and recommended dosage range after CT119X infusion |
| Adverse Events (AE) after CT119X infusion | 12 months after CT119X infusion | An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of remission(DOR) | 12 months after CT119X infusion | Participants achieving CR/PR will be included in the analysis set for DOR. DOR is defined as the time from the date of confirmed response until the date of disease relapse or death from any cause, whichever occurs first. |
| Time to response (TTR) | 12 months after CT119X infusion | The time from cell infusion to the first assessment of CR or PR |
| Overall response rate （ORR） | Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion | The proportion of patients with complete remission（CR）/partial response (PR) after CT119X infusion. |
| Progression-free survival (PFS) | 12 months after CT119X infusion | The time from the infusion of CT119X cells to the first assessment of disease progression or death. |
| Overall survival (OS) | 12 months after CT119X infusion | defined as the time from the date of receiving the infusion to the date of death from any cause |
| Time to complete response (TTCR) | 12 months after CT119X infusion | The time from cell infusion to the first assessment of CR |
| Complete response rate (CRR) | 12 months after CT119X infusion | The proportion of patients with complete response(CR) after CT119X infusion |
Countries
China
Contacts
Primary ContactAibin Liang MD,Ph.D.
Backup ContactPing Li MD
Outcome results
None listed