Back to resultsAdult B-ALL Treated by CART Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation
Primary Purpose
Adult B Acute Lymphoblastic Leukemia
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19 CAR-T
CD22 CAR-T
CD19+CD22 CAR-T
Fludarabine
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Adult B Acute Lymphoblastic Leukemia
Eligibility Criteria
Inclusion Criteria:
- Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:
- ECOG score≤2;
- To be aged 1 to 65 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;
- Pregnancy or lactation women;
- 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
Volunteers
Arm Description
The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with acute B lymphocytic leukemia expressing specific target antigens
Outcomes
Primary Outcome Measures
Number of Participants with Severe/Adverse Events as a Measure of Safety
Number of Participants with Severe/Adverse Events as a Measure of Safety
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
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
NCT ID
NCT04626726
First Posted
November 6, 2020
Last Updated
November 11, 2020
Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04626726
Brief Title
Adult B-ALL Treated by CART Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation
Official Title
A Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of CAR-T Cell in the Treatment of Adult Relapsed Refractory (R/R) Acute Lymphoblastic Leukemia Bridging Allogeneic Hematopoietic Stem Cell Transplantation
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
May 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.
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, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.
Detailed Description
This trial openly recruited 50 patients into the group and were given CAR-T treatment. Patients participating in clinical trials will be tested and evaluated in terms of treatment safety, efficacy, and response duration. As assessed by clinicians, adult B-ALL patients who meet the enrollment criteria, after adequate communication, the patient or family members voluntarily join the clinical study, and are willing to bridge allogeneic hematopoiesis within 3 months after enrollment using CAR-T therapy。
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult B 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
Volunteers
Arm Type
Experimental
Arm Description
The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with acute B lymphocytic leukemia 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 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 patients with CD22 positive tumor cells
Intervention Type
Drug
Intervention Name(s)
CD19+CD22 CAR-T
Other Intervention Name(s)
Senl_19+22
Intervention Description
CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Other Intervention Name(s)
fiu
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 as a Measure of Safety
Description
Number of Participants with Severe/Adverse Events as a Measure of Safety
Time Frame
28 days
Title
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
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
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:
ECOG score≤2;
To be aged 1 to 65 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;
Pregnancy or lactation women;
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
Adult B-ALL Treated by CART Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation
We'll reach out to this number within 24 hrs