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CAR-T for Children With Relapsed and Refractory Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT04626765
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
The Second Hospital of Hebei Medical University
Information provided by (Responsible Party):
Hebei Senlang Biotechnology Inc., Ltd.

Brief Summary:
In this study, CAR-T will be administered to children with acute lymphoblastic leukemia to explore the effect of CAR-T intervention time on the duration of complete remission and further verify the long-term safety and efficacy of CAR-T treatment.

Condition or disease Intervention/treatment Phase
Childhood Acute Lymphoblastic Leukemia Drug: CD19 CAR-T Drug: CD22 CAR-T Drug: CD 19+22 Drug: Fludarabine Drug: Cyclophosphamide Early Phase 1

Detailed Description:
After clinician evaluation, if the child meets the study criteria and after adequate communication, the parent or legal guardian voluntarily joins the clinical study, CAR-T technique can be used for related treatment, and the long-term therapeutic effect can be observed. In this trial, 50 children were publicly enrolled and treated with CAR-T. Patients participating in the clinical trial will be tested and assessed in terms of treatment safety, efficacy, and duration of response.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Children With Relapsed and Refractory Acute Lymphoblastic Leukemia
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : May 30, 2023


Arm Intervention/treatment
Experimental: volunteer
The child's parents or legal guardians voluntarily signed the informed consent form, and the child himself/herself met the enter criteria for the diagnosis of patients with acute B-lymphoblastic leukemia (B-ALL) expressing specific target antigens
Drug: CD19 CAR-T
CD19 CAR-T infusion for pediatric patients with CD19 positive tumor cells
Other Name: Senl_19

Drug: CD22 CAR-T
CD22 CAR-T infusion for pediatric patients with CD22 positive tumor cells
Other Name: Senl_22

Drug: CD 19+22
CD19+22 CAR-T infusion for pediatric patients with CD19 positive and CD22 positive tumor cells
Other Name: Senl_19+22

Drug: Fludarabine
25mg/㎡ for D-4、D-3 and D-2
Other Name: flu

Drug: Cyclophosphamide
500mg/㎡ for D-3 and D-2
Other Name: ctx




Primary Outcome Measures :
  1. Number of Participants with Severe/Adverse Events [ Time Frame: 28 days ]
    Number of Participants with Severe/Adverse Events as a Measure of Safety diagnosis

  2. CAR-T Cell expansion level [ Time Frame: 24 months ]
    Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)


Secondary Outcome Measures :
  1. Objective response rate of complete remission and partial remission [ Time Frame: 24 months ]
    Objective response rate of complete remission and partial remission

  2. Overall survival time [ Time Frame: 24 months ]
    Overall survival 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. The treat history meeting the following criteria:

    Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation; Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients; One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.

  2. There is a measurable lesions before treatment at least;
  3. ECOG score≤2;
  4. To be aged 1 to 18 years;
  5. More than a month lifetime from the consent signing date

Exclusion Criteria:

  1. Serious cardiac insufficiency, left ventricular ejection fraction<50%;
  2. Has a history of severe pulmonary function damaging;
  3. Merging other progressing malignant tumor;
  4. Merging uncontrolled infection;
  5. Merging the metabolic diseases (except diabetes);
  6. Merging severe autoimmune diseases or immunodeficiency disease;
  7. Patients with active hepatitis B or hepatitis C;
  8. Patients with HIV infection;
  9. Has a history of serious allergies on Biological products (including antibiotics);
  10. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
  11. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

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): NCT04626765


Contacts
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Contact: Jianqiang Li, PhD&MD +8631189928689 limmune@gmail.com

Locations
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China, Hebei
No.2 Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Jianqiang Li, PhD & MD    +86311-89928689    limmune@gmail.com   
Contact: Jianmin Luo, PhD & MD    +86311-66002304      
Principal Investigator: Jianmin Luo, PhD & MD         
Sponsors and Collaborators
Hebei Senlang Biotechnology Inc., Ltd.
The Second Hospital of Hebei Medical University
Investigators
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Principal Investigator: Jianmin Luo, PhD&MD The Second Hospital of Hebei Medical University
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Responsible Party: Hebei Senlang Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier: NCT04626765    
Other Study ID Numbers: CAR-T for Childhood B-ALL
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
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