Clinical Study of ssCART-19 Cells in Patients With CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia
NCT ID: NCT04825496
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
18 participants
INTERVENTIONAL
2021-04-09
2024-12-31
Brief Summary
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Detailed Description
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Primary objectives:
Determine the safety and tolerability of ssCART-19 cells in patients with refractory or relapsed acute lymphoblastic leukemia.
Secondary objectives:
1. Observe the anti-tumor response of ssCART-19 cells to refractory or relapsed acute lymphoblastic leukemia.
* Overall remission rate (ORR) assessment during the 3 months after ssCART-19 administration，ORR includes CR and CRi
* Duration of response (DOR)
* Progression-free survival (PFS)
* Overall survival (OS)
2. To characterize the in vivo cellular pharmacokinetic (PK) profile of ssCART-19 cells.
3. To characterize the pharmacodynamic (PD) profile of ssCART-19 cells.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ssCART-19 Cells
Route of administration: Intravenous injection.
Lymphodepletion conditioning:
Lymphodepletion will be conducted several days prior to ssCART-19 cells infusion.
A combination of fludarabine and cyclophosphamide will be used for lymphodepletion.
ssCART-19 Cells
Split-Dose of ssCART-19 cells will be infused, and classic "3+3" dose escalation will be applied.
Fludarabine
Fludarabine is used for lymphodepletion.
Cyclophosphamide
Cyclophosphamide is used for lymphodepletion.
Interventions
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ssCART-19 Cells
Split-Dose of ssCART-19 cells will be infused, and classic "3+3" dose escalation will be applied.
Fludarabine
Fludarabine is used for lymphodepletion.
Cyclophosphamide
Cyclophosphamide is used for lymphodepletion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
INDUSTRY
Responsible Party
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Locations
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Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd.
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ssCART-19
Identifier Type: -
Identifier Source: org_study_id
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