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

Primary Purpose

Childhood Acute Lymphoblastic Leukemia

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19 CAR-T
CD22 CAR-T
CD 19+22
Fludarabine
Cyclophosphamide
Sponsored by
Hebei Senlang Biotechnology Inc., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Acute Lymphoblastic Leukemia

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • No.2 Hospital of Hebei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

volunteer

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants with Severe/Adverse Events
Number of Participants with Severe/Adverse Events as a Measure of Safety diagnosis
CAR-T Cell expansion level
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)

Secondary Outcome Measures

Objective response rate of complete remission and partial remission
Objective response rate of complete remission and partial remission
Overall survival time
Overall survival time

Full Information

First Posted
November 6, 2020
Last Updated
November 11, 2020
Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborators
The Second Hospital of Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04626765
Brief Title
CAR-T for Children With Relapsed and Refractory Acute Lymphoblastic Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborators
The Second Hospital of Hebei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
volunteer
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CD19 CAR-T
Other Intervention Name(s)
Senl_19
Intervention Description
CD19 CAR-T infusion for pediatric patients with CD19 positive tumor cells
Intervention Type
Drug
Intervention Name(s)
CD22 CAR-T
Other Intervention Name(s)
Senl_22
Intervention Description
CD22 CAR-T infusion for pediatric patients with CD22 positive tumor cells
Intervention Type
Drug
Intervention Name(s)
CD 19+22
Other Intervention Name(s)
Senl_19+22
Intervention Description
CD19+22 CAR-T infusion for pediatric patients with CD19 positive and CD22 positive tumor cells
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Other Intervention Name(s)
flu
Intervention Description
25mg/㎡ for D-4、D-3 and D-2
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
ctx
Intervention Description
500mg/㎡ for D-3 and D-2
Primary Outcome Measure Information:
Title
Number of Participants with Severe/Adverse Events
Description
Number of Participants with Severe/Adverse Events as a Measure of Safety diagnosis
Time Frame
28 days
Title
CAR-T Cell expansion level
Description
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Objective response rate of complete remission and partial remission
Description
Objective response rate of complete remission and partial remission
Time Frame
24 months
Title
Overall survival time
Description
Overall survival time
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria： 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. There is a measurable lesions before treatment at least; ECOG score≤2; To be aged 1 to 18 years; More than a month lifetime from the consent signing date Exclusion Criteria: Serious cardiac insufficiency, left ventricular ejection fraction<50%; Has a history of severe pulmonary function damaging; Merging other progressing malignant tumor; Merging uncontrolled infection; Merging the metabolic diseases (except diabetes); Merging severe autoimmune diseases or immunodeficiency disease; Patients with active hepatitis B or hepatitis C; Patients with HIV infection; Has a history of serious allergies on Biological products (including antibiotics); Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month; Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianqiang Li, PhD&MD
Phone
+8631189928689
Email
limmune@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmin Luo, PhD&MD
Organizational Affiliation
The Second Hospital of Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
No.2 Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianqiang Li, PhD & MD
Phone
+86311-89928689
Email
limmune@gmail.com
First Name & Middle Initial & Last Name & Degree
Jianmin Luo, PhD & MD
Phone
+86311-66002304
First Name & Middle Initial & Last Name & Degree
Jianmin Luo, PhD & MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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