Overview
Clinical Study of ssCART-19 Cells in Patients With CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia
Status:
Recruiting
Recruiting
Trial end date:
2024-12-31
2024-12-31
Target enrollment:
0
0
Participant gender:
All
All
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 refractory acute lymphoblastic leukemia.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Shanghai Unicar-Therapy Bio-medicine Technology Co.,LtdCollaborator:
The First Affiliated Hospital of Soochow UniversityTreatments:
Cyclophosphamide
Fludarabine
Criteria
Inclusion Criteria:1. 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
2. CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow
cytometry
3. Bone marrow with ≥ 5% lymphoblasts by morphologic assessment
4. 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
5. Informed consent is signed by the subject
6. Age 18 to 65
7. 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
8. Qualified T cell amplification
9. Eastern cooperative oncology group (ECOG) performance status of 0 to 1
10. Vascular conditions for apheresis
11. The estimated survival time is more than 3 months
Exclusion Criteria:
1. Isolated extra-medullary disease relapse
2. Combined with other malignant tumors
3. Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other antiCD19
therapy
4. Has had immunosuppressants or hormones within 2 weeks before signing informed consent,
or plan to use immunosuppressants or hormones after signing informed consent
5. 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
6. Has uncontrolled bacteria, fungi, viruses, mycoplasma or other types of infections
7. Infected with HIV, syphilis or COVID-19
8. Has a history of severe immediate hypersensitivity to aminoglycosides
9. Has past or present CNS diseases, such as epilepsy, cerebrovascular
ischemia/hemorrhage, dementia, cerebellar diseases or any CNS-related autoimmune
diseases
10. 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
11. With primary immunodeficiency
12. Has had severe immediate hypersensitivity reaction to any drug to be used in this
study
13. Has had treat with live vaccine within 6 weeks prior to screening
14. Pregnant or lactating women
15. Has active autoimmune diseases
16. Has active acute or chronic graft-versus-host disease (GVHD) before signing informed
consent
17. Patient has an investigational medicinal product within 3 months before signing
informed consent
18. Patients with other conditions making the patients unsuitable for receiving cell
therapy as judged by the investigator