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

September 17, 2023 updated by: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Fludarabine
Fludarabine is used for lymphodepletion.
Other Names:
  • FA
Drug: Cyclophosphamide
Cyclophosphamide is used for lymphodepletion.
Other Names:
  • CTX
Genetic: ssCART-19 Cells
Split-Dose of ssCART-19 cells will be infused, and classic "3+3" dose escalation will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Limiting Toxicity (DLT)
Time Frame: 28 days

Determine the safety and tolerability of ssCART-19 in patients with refractory or relapsed acute lymphoblastic leukemia.

Safety measures include adverse events as assessed by CTCAE v5.0.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi)
Time Frame: 3 months
Efficacy of ssCART-19 as measured by ORR during the 3 months after ssCART-19 infusion, which includes CR and CRi.
3 months
Duration of remission (DOR)
Time Frame: 24 months
Statistical parameter:Duration of remission (DOR)
24 months
Progression-free Survival (PFS)
Time Frame: 24 months
Statistical parameter:Progression-free Survival (PFS)
24 months
Overall survival (OS)
Time Frame: 24 months
Statistical parameter:Overall survival (OS)
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
cellular pharmacokinetic (PK) profile of ssCART-19 cells
Time Frame: 24 months
Number of DNA copies of ssCART-19 cells
24 months
Anti-drug antibody
Time Frame: 24 months
Detect titer of anti-drug antibody (ADA)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Collaborators

The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 28, 2021

First Submitted That Met QC Criteria

March 28, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ssCART-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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