Status:
UNKNOWN
Clinical Study of ssCART-19 Cells in Patients With CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia
Lead Sponsor:
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Collaborating Sponsors:
The First Affiliated Hospital of Soochow University
Conditions:
Relapsed or Refractory Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of ssCART-19 in the treatment of patients with CD19 positive relapsed or refractor...
Detailed Description
This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of ssCART-19 in the treatment of patients with CD19 positive relapsed or refractor...
Eligibility Criteria
Inclusion
- Relapsed or refractory acute lymphoblastic leukemia (ALL):(1)Any Relaps after first remission OR (2)Any BM relapse after allogeneic SCT and must be ≥ 3 months from SCT at the time of ssCART-19 infusion OR (3)failed to reach CR after 2 cycles of induction chemotherapy regimen OR (4)Patients with Ph+ ALL are eligible if they are intolerant to or have failed two lines of TKI therapy, or if TKI therapy is contraindicated
- CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment
- Adequate organ function defined as:(1)left ventricular ejection fraction ≥ 50% by echocardiogram；(2)creatinine ≤ 1.6mg/dl；(3)ALT and AST≤3 times the ULN for age, total bilirubin ≤ 2.0mg/dl；(4)Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation \> 91% on room air
- Informed consent is signed by the subject
- Age 18 to 65
- Fertility of men, to ensure that sexual partners can effectively contraception; Women with fertility use effective contraceptive measures and agree to use contraceptive measures throughout the study period
- Qualified T cell amplification
- Eastern cooperative oncology group (ECOG) performance status of 0 to 1
- Vascular conditions for apheresis
- The estimated survival time is more than 3 months
Exclusion
- Isolated extra-medullary disease relapse
- Combined with other malignant tumors
- Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other antiCD19 therapy
- Has had immunosuppressants or hormones within 2 weeks before signing informed consent, or plan to use immunosuppressants or hormones after signing informed consent
- Patients complying with any of hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive, hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copies being more than the lower limit of detection, hepatitis C antibody (HCV-Ab) positive, anti-treponemia pallidum antibody (TP-Ab) positive, EBV-DNA, and CMV-DNA copies being more than the lower limit of detection
- Has uncontrolled bacteria, fungi, viruses, mycoplasma or other types of infections
- Infected with HIV, syphilis or COVID-19
- Has a history of severe immediate hypersensitivity to aminoglycosides
- Has past or present CNS diseases, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases or any CNS-related autoimmune diseases
- Has undergone cardiac angioplasty or stent implantation within 12 months before signing informed consent, or having a history of myocardial infarction, unstable angina pectoris or other clinically significant heart diseases
- With primary immunodeficiency
- Has had severe immediate hypersensitivity reaction to any drug to be used in this study
- Has had treat with live vaccine within 6 weeks prior to screening
- Pregnant or lactating women
- Has active autoimmune diseases
- Has active acute or chronic graft-versus-host disease (GVHD) before signing informed consent
- Patient has an investigational medicinal product within 3 months before signing informed consent
- Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator
Key Trial Info
Start Date :
April 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04825496
Start Date
April 9 2021
End Date
December 31 2024
Last Update
September 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd.
Shanghai, Shanghai Municipality, China, 201210