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CD7 CAR-T Cells for Patients With R/R CD7+ NK/T Cell Lymphoma,T-lymphoblastic Lymphoma and Acute Lymphocytic 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: NCT04004637
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : February 7, 2020
Sponsor:
Collaborator:
The First Affiliated Hospital of Zhengzhou University
Information provided by (Responsible Party):
PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Brief Summary:
This study is designed to explore the safety and efficacy of CD7 CAR-T Cells for patients with relapse/refractory CD7+ NK/T cell lymphoma ,T-lymphoblastic lymphoma and Acute Lymphocytic Leukemia. And to evaluate the pharmacokinetics of CD7 CAR-T cells in patients.

Condition or disease Intervention/treatment Phase
T-lymphoblastic Lymphoma NK/T Cell Lymphoma Acute Lymphocytic Leukemia Drug: CD7 CAR-T cells infusion Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD7 CAR-T Cells for Patients With Relapse/Refractory CD7+ NK/T Cell Lymphoma ,T-lymphoblastic Lymphoma and Acute Lymphocytic Leukemia
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021


Arm Intervention/treatment
Experimental: CD7 CAR-T cells Infusion Drug: CD7 CAR-T cells infusion

Biological: CD7 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD7 CAR-T cells infusion are allowed within 2 weeks after treatment.

CD7 CAR-T cells infusion: 30-60 minutes before infusion, H1 anti-histamine agents are applied (acetaminophen 30mg,po.; promethazine 25mg,i.v. ; diphenhydramine 0.5-1mg/kg, no more than 50mg.). Non-physiological doses of corticosteroids are not applied for patients during treatment or recovery unless a life-threatening emergency occurs. CD7 CAR-T cells are infused into patients for one or two times, the number of infused CD7 CAR-T cells are 0.5-5×10^6/kg.





Primary Outcome Measures :
  1. Identification of the dose limiting toxicity (DLT) [ Time Frame: Time Frame: 4 weeks after CAR T cell infusion ]
    Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 5 and the number of patients experiencing DLT will be evaluated.


Secondary Outcome Measures :
  1. In vivo persistence/expansion of infused CAR T cell [ Time Frame: Up to 2 years ]
    Detection of infused CAR T cell in the peripheral blood.

  2. Determine the effects of CART-CD7 infusion on T cells and CD7 expression in vivo. [ Time Frame: Up to 2 years ]
  3. Overall Response Rate (ORR) [ Time Frame: 4 weeks after CAR T cell infusion ]
  4. Overall Survival [ Time Frame: Up to 2 years ]
  5. Disease-free survival [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Aged 7 to 70 years.

    2. The expected survival period is more than 12 weeks.

    3. ECOG: 0-2.

    4. Male and female subjects with CD7+ NK/T cell lymphoma ,T-lymphoblastic lymphoma and Acute Lymphocytic Leukemia in patients with no available curative treatment options will be enrolled:

    1. Not achieved PR after the standard first-line treatment for at least 4 courses.
    2. Relapse or progression after standardized treatment.
    3. Patients With NK/T Cell Lymphoma or T-lymphoblastic Lymphoma need to have at least 1 tumor lesions can be evaluated.

    5. Cardiac left ventricle ejection fraction ≥40%.

    6. Serum creatinine≤1.5 ULN; oxygen saturation of blood >91%.

    7. Total bilirubin≤1.5×ULN; Serum ALT and AST≤2.5 ULN.

    8. Able to understand this study and have signed informed consent.

Exclusion Criteria:

  • 1. Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.

    2. Patients with malignant tumors other than NK/T cell lymphoma , T-lymphoblastic lymphoma and Acute Lymphocytic Leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer, local prostate after radical surgery, breast ductal carcinoma in situ after cancer and radical surgery.

    3. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive.

    4. Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), severe arrhythmia.

    5. Unstable systemic diseases judged by investigator, including but not limited to severe liver, kidney or metabolic diseases needing medical treatment.

    6. Active or uncontrollable infections (except for mild genitourinary infections and upper respiratory tract infections) that require systemic treatment within 7 days prior to screening; 7. Women who are pregnant or breastfeeding, female subject who plans to have a pregnancy within 1 year after cell infusion, and male subject who plans to have a pregnancy within 1 year after cell infusion.

    8. Subject who have received CAR-T treatment or other genetically modified cell therapy before screening; 9. Subjects who are receiving systemic steroid therapy within 7 days prior to screening or who require long-term systemic steroid therapy judged by investigator (except for inhaled or topical use); 10. Participated in other clinical studies within 3 months prior to screening. 11. Patients with active CNS involvement by malignancy. 12. Not suitable for cell preparation. 13. Researchers consider it inappropriate to participate in the trial.


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): NCT04004637


Contacts
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Contact: Mingzhi Zhang, Doctor +8613838565629 mingzhi_zhang@126.com

Locations
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China, Henan
First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450000
Contact: Min Yao, Bachelor's    +8618355313511    1248135168@qq.com   
Sponsors and Collaborators
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
The First Affiliated Hospital of Zhengzhou University
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Responsible Party: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT04004637    
Other Study ID Numbers: PG-CART-007-001
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020

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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 PersonGen BioTherapeutics (Suzhou) Co., Ltd.:
NK/T cell lymphoma
T-lymphoblastic lymphoma
Acute Lymphocytic Leukemia
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases