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Humanized CD7 CAR T-cell Therapy for r/r CD7+ Acute Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04762485
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : June 2, 2021
Sponsor:
Collaborator:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

Study Description
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Brief Summary:
This is a prospective,open-label, single center and single arm phase 1/2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive acute leukemia.

Condition or disease Intervention/treatment Phase
T Lymphoblastic Leukemia/Lymphoma Mixed Phenotype Acute Leukemia Acute Myeloid Leukemia Biological: Humanized CD7 CAR-T cells Phase 1 Phase 2

Detailed Description:
The patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory acute leukemia.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Humanized Chimeric Antigen Receptor T Cells Against CD7 for Refractory/Relapsed CD7+ Acute Leukemia
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: CD38 positive relapsed or refractory acute leukemia
Biological/Vaccine: Humanized CD7 CAR-T cells Split intravenous infusion of CD7 CAR-T cells [dose escalating infusion of (0.5- 10)x10^6 CD7 CAR-T cells/kg
 Biological: Humanized CD7 CAR-T cells
Split intravenous infusion of CD7 CAR-T cells [dose escalating infusion of (0.5-10)x10^6 CD7 CAR-T cells/kg


Outcome Measures
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Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 12 months ]
    Adverse events are evaluated with CTCAE V5.0


Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 2 years ]
    ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.

  2. Cumulative incidence of relapse(CIR) [ Time Frame: 2 years ]
    time from the date of achievement of a remission until the date of relapse.

  3. the duration of CAR T-cells in vivo [ Time Frame: 2 years ]
    the time of CAR-T cells' persistence in blood and the copies of CAR-T cells


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed CD7 positive relapsed/refractory acute leukemia.
  2. Age 12-65 years.
  3. Eastern Cooperative Oncology Group (ECOG) score 0-2.
  4. CD7 on leukemia is >30% positive detected with flow cytometry.
  5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
  6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL.

Exclusion Criteria:

  1. Patients are pregnant or lactating
  2. Patients with congenital immunodeficiency.
  3. Patients with central nervous system leukemia.
  4. Patients with uncontrolled active infection.
  5. Patients with active hepatitis B or hepatitis C infection.
  6. Patients with HIV infection.
  7. Patients with atrial or venous thrombosis or embolism.
  8. Patients with myo-infarction or severe arrythmia in the recent 6 months.
  9. Other comorbidities that investigators considered not suitable for this study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04762485


Contacts
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Contact: xiaowen tang, Ph.D (0086)51267781856 xwtang1020@163.com
Contact: Lin Yang, Ph.D (0086)18896802149 ylyh188@163.com

Locations
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China, (Select)
The First Affiliated Hospital of Soochow University Recruiting
Suzhou, (Select), China, 215000
Contact: xiaowen tang, phd    (0086)51267781856    xwtang1020@163.com   
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Investigators
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Principal Investigator: xiaowen tang, Ph.D The First Affiliated Hospital of Soochow University
More Information
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Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT04762485    
Other Study ID Numbers: PGSDFYY 202101
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital of Soochow University:
CD7 Positive
CAR-T
Additional relevant MeSH terms:
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Leukemia
Acute Disease
Neoplasms by Histologic Type
 Neoplasms
Disease Attributes
Pathologic Processes