Clinical Study of ssCART-19 Cells in Patients With CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    18
  • sponsor
    Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Updated on 26 May 2022

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.

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 refractory acute lymphoblastic leukemia.

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.

Details
Condition Relapsed or Refractory Acute Lymphoblastic Leukemia
Treatment cyclophosphamide, Fludarabine, ssCART-19 Cells
Clinical Study IdentifierNCT04825496
SponsorShanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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