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Clinical Trial of CAR-T in the Treatment of Relapsed and Refractory Hematopoietic and Lymphoid Tissue Tumors in Children

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ClinicalTrials.gov Identifier: NCT04610125
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : October 30, 2020
Sponsor:
Collaborator:
Hebei Medical University Fourth Hospital
Information provided by (Responsible Party):
Hebei Senlang Biotechnology Inc., Ltd.

Brief Summary:
This is an open, single-arm, prospective,clinical study to evaluate efficacy and safety of Auto CAR-T cell injection in the treatment of recurrent or refractory Hematopoietic and Lymphoid Tissue Tumors in Children

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: Auto CAR-T Drug: Cyclophosphamide,Fludarabine Procedure: Leukapheresis Not Applicable

Detailed Description:
A single car consists of scFv, hinge region, transmembrane region, costimulatory domain and zeta subunit of CD3.Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of CAR-T in the Treatment of Relapsed and Refractory Hematopoietic and Lymphoid Tissue Tumors in Children
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : June 22, 2023
Estimated Study Completion Date : June 22, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Auto CAR-T
Patients will be treated with Auto CAR-T cells
Biological: Auto CAR-T
Biological: Auto CAR-T

Drug: Cyclophosphamide,Fludarabine
Drug: Cyclophosphamide,Fludarabine

Procedure: Leukapheresis
Leukapheresis




Primary Outcome Measures :
  1. Safety: Incidence and severity of adverse events [ Time Frame: First month post CAR-T cells infusion ]
    To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

  2. Efficacy: Remission Rate [ Time Frame: 3 months post CAR-T cells infusion ]
    Remission Rate including complete remission(CR)、partial response(PR)、No remission(NR)、progressive disease(PD)


Secondary Outcome Measures :
  1. Efficacy:duration of response (DOR) [ Time Frame: 24 months post CAR-T cells infusion ]
    duration of response (DOR)

  2. Efficacy: progression-free survival (PFS) [ Time Frame: 24 months post CAR-T cells infusion ]
    progression-free survival (PFS) time



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
  2. Patients with relapsed and refractory hematopoiesis and lymphoid tissue tumors confirmed by clinical diagnosis;
  3. Age: 1-18 years (including boundary value), both male and female;
  4. Subjects with Lansky score ≥ 50;
  5. The results of treatment-related antigens were positive;
  6. The expected survival time is more than 3 months from the date of signing the informed consent.

Exclusion Criteria:

  1. Severe cardiac insufficiency and left ventricular ejection fraction < 50%;
  2. He had a history of severe lung function damage;
  3. Combined with other advanced malignant tumors;
  4. Severe infection was found and could not be effectively controlled;
  5. With metabolic diseases (except diabetes mellitus);
  6. Combined with severe autoimmune disease or congenital immunodeficiency;
  7. Untreated active hepatitis (hepatitis B, defined as positive HBsAg, HBV-DNA ≥ 500 IU / ml and abnormal liver function; hepatitis C, defined as hepatitis C antibody [HCV AB] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined with hepatitis B and hepatitis C co infection;
  8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
  9. Severe allergy history of biological products (including antibiotics);
  10. Patients with acute graft-versus-host reaction (GVHD) after one month of discontinuation of immunosuppressants were still present;
  11. The presence of other serious physical or mental illness or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients considered unsuitable for the study by the investigator.

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): NCT04610125


Contacts
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Contact: Jianqiang Li, PhD&MD 008615511369555 limmune@gmail.com

Locations
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China, Hebei
Pediatric hematology, Hebei Medical University Fourth Hospital Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Lian Jiang, MD         
Principal Investigator: Lian Jiang, MD         
Sub-Investigator: Jianqiang Li, PhD & MD         
Sponsors and Collaborators
Hebei Senlang Biotechnology Inc., Ltd.
Hebei Medical University Fourth Hospital
Investigators
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Principal Investigator: Lian Jiang, MD Hebei Medical University Fourth Hospital
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Responsible Party: Hebei Senlang Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier: NCT04610125    
Other Study ID Numbers: Children CAR-T
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists