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出境医 / 临床实验 / A Clinical Research of CD22-Targeted CAR-T in B Cell Malignancies

A Clinical Research of CD22-Targeted CAR-T in B Cell Malignancies

Study Description
Brief Summary:
Evaluation of the efficacy and safety of CD22-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of recurrent or refractory CD22 positive B cell acute lymphoblastic leukemia (B-ALL)

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Follicular Lymphoma Primary Cutaneous Follicle Centre Lymphoma Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue Mantle Cell Lymphoma Plasma Cell Neoplasm B Cell Lymphoma Drug: Autologous chimeric antigen receptor T cell transfusing agent targeting CD22 Phase 1

Study Design
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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: Clinical Study of CD22 CAR T Cells in the Treatment of Patients With Relapsed or Refractory CD22 Positive B Cells With Acute Lymphoblastic Leukemia
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: CAR-CD22 Cell immunotherapy
Enrolled patients will receive CAR-CD22 cell immunotherapy with a novel specific chimeric antigen receptor targeting CD22 antigen by infusion.
Drug: Autologous chimeric antigen receptor T cell transfusing agent targeting CD22
The enrolled patients will receive autologous-derived CD22-targeted CAR-T cells in 1 day with 100% of the total expected dosage after receiving lymphodepleting chemotherapy

Outcome Measures
Primary Outcome Measures :
  1. Adverse Events That Are Related to Treatment [ Time Frame: 2 years ]
    Determine the toxicity profile of the CD22 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.03

  2. The effect after treatment [ Time Frame: 24 weeks ]
    ORR within 24 weeks after infusion (CR+CRi)


Secondary Outcome Measures :
  1. In vivo existence of Anti-CD22 CAR-T cells [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male and female subjects with CD22+ B cell malignancies in patients who have no available curative treatment options except stem cell transplantation, with limited prognosis (several months to < 2 year survival) and no available treatment option to achieve complete remission prior to transplant. Some patients who have enrolled to other CD22-CAR-T cell therapy trials may be eligible if their CD22-CAR-T cells cannot be produced successfully because they have insufficient T cells to allow the CD22-CAR-T cells to be made; their T cells are inefficiently transduced with CAR viruses; or their CAR-T cell expansion is failed. All of those patients must meet the following criteria:

  1. Eligible diseases: Acute lymphocytic leukemia (ALL), Chronic lymphocytic leukemia (CLL), Follicular lymphoma, Mantle cell lymphoma, B-cell prolymphocytic leukemia, and diffuse large cell lymphoma, previously identified as CD22+.
  2. Patients 3 years of age or older, and must have a life expectancy > 12 weeks.
  3. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
  4. Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR CD22 cells.
  5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
  6. Ability to give informed consent.

Exclusion Criteria:

  1. Patients with symptomatic central nervous system (CNS) involvement.
  2. Pregnant or nursing women may not participate.
  3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  4. Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
  5. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
  6. Previously treatment with any gene therapy products.
  7. The existence of unstable or active ulcers or gastrointestinal bleeding.
  8. Patients with a history of organ transplantation or are waiting for organ transplantation.
  9. Patients need anticoagulant therapy (such as warfarin or heparin).
  10. Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel at a dose > 75mg/d).
Contacts and Locations

Contacts
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Contact: Lin Yang, Ph.D 86-0551-65728070 lin.yang@persongen.com.cn

Locations
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China, Anhui
PersonGen·Anke cellular therapeutics Co., Ltd Recruiting
Hefei, Anhui, China, 230088
Contact: Lin Yang, Ph.D         
Principal Investigator: Lin Yang, Ph.D         
Sponsors and Collaborators
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Anhui Provincial Hospital
Tracking Information
First Submitted Date  ICMJE June 25, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date June 27, 2019
Actual Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • Adverse Events That Are Related to Treatment [ Time Frame: 2 years ]
    Determine the toxicity profile of the CD22 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.03
  • The effect after treatment [ Time Frame: 24 weeks ]
    ORR within 24 weeks after infusion (CR+CRi)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
In vivo existence of Anti-CD22 CAR-T cells [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Research of CD22-Targeted CAR-T in B Cell Malignancies
Official Title  ICMJE Clinical Study of CD22 CAR T Cells in the Treatment of Patients With Relapsed or Refractory CD22 Positive B Cells With Acute Lymphoblastic Leukemia
Brief Summary Evaluation of the efficacy and safety of CD22-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of recurrent or refractory CD22 positive B cell acute lymphoblastic leukemia (B-ALL)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma
  • Primary Cutaneous Follicle Centre Lymphoma
  • Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
  • Mantle Cell Lymphoma
  • Plasma Cell Neoplasm
  • B Cell Lymphoma
Intervention  ICMJE Drug: Autologous chimeric antigen receptor T cell transfusing agent targeting CD22
The enrolled patients will receive autologous-derived CD22-targeted CAR-T cells in 1 day with 100% of the total expected dosage after receiving lymphodepleting chemotherapy
Study Arms  ICMJE Experimental: CAR-CD22 Cell immunotherapy
Enrolled patients will receive CAR-CD22 cell immunotherapy with a novel specific chimeric antigen receptor targeting CD22 antigen by infusion.
Intervention: Drug: Autologous chimeric antigen receptor T cell transfusing agent targeting CD22
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 25, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Male and female subjects with CD22+ B cell malignancies in patients who have no available curative treatment options except stem cell transplantation, with limited prognosis (several months to < 2 year survival) and no available treatment option to achieve complete remission prior to transplant. Some patients who have enrolled to other CD22-CAR-T cell therapy trials may be eligible if their CD22-CAR-T cells cannot be produced successfully because they have insufficient T cells to allow the CD22-CAR-T cells to be made; their T cells are inefficiently transduced with CAR viruses; or their CAR-T cell expansion is failed. All of those patients must meet the following criteria:

  1. Eligible diseases: Acute lymphocytic leukemia (ALL), Chronic lymphocytic leukemia (CLL), Follicular lymphoma, Mantle cell lymphoma, B-cell prolymphocytic leukemia, and diffuse large cell lymphoma, previously identified as CD22+.
  2. Patients 3 years of age or older, and must have a life expectancy > 12 weeks.
  3. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
  4. Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR CD22 cells.
  5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
  6. Ability to give informed consent.

Exclusion Criteria:

  1. Patients with symptomatic central nervous system (CNS) involvement.
  2. Pregnant or nursing women may not participate.
  3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  4. Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
  5. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
  6. Previously treatment with any gene therapy products.
  7. The existence of unstable or active ulcers or gastrointestinal bleeding.
  8. Patients with a history of organ transplantation or are waiting for organ transplantation.
  9. Patients need anticoagulant therapy (such as warfarin or heparin).
  10. Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel at a dose > 75mg/d).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03999697
Other Study ID Numbers  ICMJE PG-CART-22-I-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Study Sponsor  ICMJE PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborators  ICMJE Anhui Provincial Hospital
Investigators  ICMJE Not Provided
PRS Account PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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