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Senl-h19 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Primary Purpose

B-ALL

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Senl-h19 CAR-T
Sponsored by
Hebei Senlang Biotechnology Inc., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-ALL focused on measuring B-ALL,h19,CAR-T

Eligibility Criteria

2 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet; 2. A definite diagnosis of relapsed and refractory acute B-lymphoblastic leukemia meets one of the following criteria: a) Mouse CAR-T treatment fails or relapses; B) Unable to bridge the graft for any reason; 3. Eastern Cooperative Oncology Group (ECOG) score ≤2; 4. Age ≥2 years old, male or female 5. CD19 positive tumor cells were detected by immunohistochemistry or flow cytometry; 6. Expected survival longer than 3 months; 7. The collection time of peripheral blood mononuclear immune cells must be at least 2 weeks from the last radiotherapy or systematic treatment of patients;

Exclusion Criteria:

  • 1. Severe cardiac insufficiency; 2. Have a history of severe lung impairment; 3. Complicated with other advanced malignant tumors; 4. Complicated with severe or persistent infection that cannot be effectively controlled; 5. Complicated with severe autoimmune diseases or congenital immune deficiency; 6. Active hepatitis (HBVDNA or HCVRNA positive); Human immunodeficiency virus (HIV) infection or syphilis infection; 8. Have a history of severe allergy to biological products (including antibiotics); 9. The female patient is pregnant and lactating, or has a pregnancy plan within 12 months; 10. Conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.

Sites / Locations

  • Hebei yanda Ludaopei HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Senl-h19 CAR-T

Arm Description

Patients will be treated with Senl-h19 CAR-T cells

Outcomes

Primary Outcome Measures

Safety: Incidence and severity of adverse events
To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Efficacy: Remission Rate
Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)

Secondary Outcome Measures

duration of response (DOR)
duration of response (DOR)
progression-free survival (PFS)
progression-free survival (PFS) time
CAR-T proliferation
the copy number of Senl h19 CAR- T cells in the genomes of PBMC by qPCR method
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

Full Information

First Posted
March 8, 2021
Last Updated
March 8, 2021
Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04792593
Brief Title
Senl-h19 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Official Title
Senl-h19 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
December 10, 2021 (Anticipated)
Study Completion Date
February 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Senlang Biotechnology Inc., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
This study is an open, dose-escalating clinical study, taking patients with relapsed or refractory acute lymphoblastic leukemia as the test subjects, including mouse-derived CAR-T treatment failure or relapse, or for any reason cannot bridge the transplant r/r B-ALL.
Detailed Description
Main research objectives: To evaluate the safety and efficacy of Senl-h19 CAR-T in patients with relapsed or refractory acute lymphoblastic leukemia Secondary research purpose To investigate the cytokinetic characteristics of Senl-h19 CAR-T in patients with relapsed or refractory acute lymphoblastic leukemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-ALL
Keywords
B-ALL,h19,CAR-T

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Senl-h19 CAR-T
Arm Type
Experimental
Arm Description
Patients will be treated with Senl-h19 CAR-T cells
Intervention Type
Biological
Intervention Name(s)
Senl-h19 CAR-T
Other Intervention Name(s)
CD19 CAR-T
Intervention Description
Biological: Senl-h19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis
Primary Outcome Measure Information:
Title
Safety: Incidence and severity of adverse events
Description
To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Time Frame
First 1 month post CAR-T cells infusion
Title
Efficacy: Remission Rate
Description
Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
Time Frame
3 months post CAR-T cells infusion
Secondary Outcome Measure Information:
Title
duration of response (DOR)
Description
duration of response (DOR)
Time Frame
24 months post CAR-T cells infusion
Title
progression-free survival (PFS)
Description
progression-free survival (PFS) time
Time Frame
24 months post CAR-T cells infusion
Title
CAR-T proliferation
Description
the copy number of Senl h19 CAR- T cells in the genomes of PBMC by qPCR method
Time Frame
3 months post CAR-T cells infusion
Title
Cytokine release
Description
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
Time Frame
First 1 month post CAR-T cells infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet; 2. A definite diagnosis of relapsed and refractory acute B-lymphoblastic leukemia meets one of the following criteria: a) Mouse CAR-T treatment fails or relapses; B) Unable to bridge the graft for any reason; 3. Eastern Cooperative Oncology Group (ECOG) score ≤2; 4. Age ≥2 years old, male or female 5. CD19 positive tumor cells were detected by immunohistochemistry or flow cytometry; 6. Expected survival longer than 3 months; 7. The collection time of peripheral blood mononuclear immune cells must be at least 2 weeks from the last radiotherapy or systematic treatment of patients; Exclusion Criteria: 1. Severe cardiac insufficiency; 2. Have a history of severe lung impairment; 3. Complicated with other advanced malignant tumors; 4. Complicated with severe or persistent infection that cannot be effectively controlled; 5. Complicated with severe autoimmune diseases or congenital immune deficiency; 6. Active hepatitis (HBVDNA or HCVRNA positive); Human immunodeficiency virus (HIV) infection or syphilis infection; 8. Have a history of severe allergy to biological products (including antibiotics); 9. The female patient is pregnant and lactating, or has a pregnancy plan within 12 months; 10. Conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peihua MD Lu, PhD
Phone
008618611636172
Email
peihua_lu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianqiang MD Li, PhD
Phone
008615511369555
Email
limmune@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peihua MD Lu, PhD
Organizational Affiliation
Hebei Yanda Ludaopei Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebei yanda Ludaopei Hospital
City
Yanda
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peihua MD Lu, PhD
Phone
008618611636172
Email
peihua_lu@126.com

12. IPD Sharing Statement

Learn more about this trial

Senl-h19 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

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