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Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia

Primary Purpose

B-ALL

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CD19 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, CD19 CAR-T

Eligibility Criteria

2 Years - 65 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 regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
  2. A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation;
  3. ECOG Scores: 0~2
  4. CD19 positivewere detected by immunohistochemistry or flow cytometry;
  5. Estimated survival time>3 months;
  6. Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.

Exclusion Criteria:

  1. Serious cardiac insufficiency；
  2. Has a history of severe pulmonary function damaging;
  3. With other tumors which is/are in advanced malignant and has/have systemic metastasis;
  4. Severe or persistent infection that cannot be effectively controlled；
  5. Merging severe autoimmune diseases or immunodeficiency disease;
  6. Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);
  7. Patients with HIV infection or syphilis infection;
  8. Has a history of serious allergies on Biological products (including antibiotics);
  9. Being pregnant and lactating or having pregnancy within 12 months;
  10. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Sites / Locations

  • Hebei yanda Ludaopei HospitalRecruiting
  • BeiJing Ludaopei HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1904B CAR-T

Arm Description

Patients will be treated with CD19 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 SL1904B 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

Efficacy:duration of response (DOR)
duration of response (DOR)
Efficacy: progression-free survival (PFS)
progression-free survival (PFS) time
CAR-T proliferation
the copy number of CD19 CAR- T cells in the genomes of PBMC by qPCR method and percentage of CD19 CAR- T cells measured by flow cytometry method
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

Full Information

First Posted
September 4, 2020
Last Updated
September 4, 2020
Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborators
Hebei Yanda Ludaopei Hospital, Beijing Lu Daopei Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04546893
Brief Title
Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia
Official Title
Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborators
Hebei Yanda Ludaopei Hospital, Beijing Lu Daopei Hospital

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 is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD19 CAR-T cell in the treatment of recurrent or refractory B-ALL
Detailed Description
The CARs consist of an anti-CD19 single-chain variable fragment（scFv） that was derived from the FMC63 mouse hybridoma, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. 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. The Main research objectives: To evaluate the safety and efficacy of 1904B in patients with recurrent or refractory B-ALL The Secondary research objectives: To investigate the cytokinetic characteristics of 1904B in patients with recurrent or refractory B-ALL

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-ALL
Keywords
B-ALL, CD19 CAR-T

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1904B CAR-T
Arm Type
Experimental
Arm Description
Patients will be treated with CD19 CAR-T cells
Intervention Type
Biological
Intervention Name(s)
CD19 CAR-T
Intervention Description
Biological: CD19 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 SL1904B infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Time Frame
First 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
Efficacy:duration of response (DOR)
Description
duration of response (DOR)
Time Frame
24 months post CAR-T cells infusion
Title
Efficacy: 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 CD19 CAR- T cells in the genomes of PBMC by qPCR method and percentage of CD19 CAR- T cells measured by flow cytometry 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 month post CAR-T cells infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation; ECOG Scores: 0~2 CD19 positivewere detected by immunohistochemistry or flow cytometry; Estimated survival time>3 months; Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment. Exclusion Criteria: Serious cardiac insufficiency； Has a history of severe pulmonary function damaging; With other tumors which is/are in advanced malignant and has/have systemic metastasis; Severe or persistent infection that cannot be effectively controlled； Merging severe autoimmune diseases or immunodeficiency disease; Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]); Patients with HIV infection or syphilis infection; Has a history of serious allergies on Biological products (including antibiotics); Being pregnant and lactating or having pregnancy within 12 months; Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peihua Lu, PhD&MD
Phone
008618611636172
Email
peihua_lu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianqiang Li, PhD&MD
Phone
008615511369555
Email
limmune@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peihua Lu, PhD&MD
Organizational Affiliation
Hebei Yanda Ludaopei Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebei yanda Ludaopei Hospital
City
Hebei
State/Province
Sanhe
ZIP/Postal Code
065200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peihua Lu, PhD&MD
Phone
008618611636172
Email
peihua_lu@126.com
First Name & Middle Initial & Last Name & Degree
Peihua Lu, PhD&MD
First Name & Middle Initial & Last Name & Degree
Jianqiang Li, PhD&MD
Facility Name
BeiJing Ludaopei Hospital
City
Beijing
State/Province
Yizhuang
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peihua Lu, PhD&MD
Phone
008618611636172
Email
peihua_lu@126.com

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia

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