Back to resultsImmunotherapy With CD19 CAR T-cells for B-Cell Leukemia
Primary Purpose
Leukemia
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Anti-CD19-CAR
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring CAR-T, Leukemia
Eligibility Criteria
Inclusion Criteria:
- Relapsed or refractory B cell non-hodgkin lymphoma.
- KPS>60.
- Life expectancy>3 months.
- Gender unlimited, age from 2 years to 70 years.
- CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
- Patients who have failed at least one line of a standard treatment.
- No serious mental disorder.
- Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
- No other serious diseases(autoimmune disease, immunodeficiency etc.).
- No other tumors.
- Patients volunteer to participate in the research.
- Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial
Exclusion Criteria:
- KPS<50.
- Patients are allergic to cytokines.
- Uncontrolled active infection.
- Acute or chronic GVHD.
- Treated with T cell inhibitor.
- Pregnancy and nursing females.
- HIV/HBV/HCV Infection.
- Other situations we think improper for the research.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental:3
Arm Description
Leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
Outcomes
Primary Outcome Measures
Adverse events of each patient
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Survival time of Anti-CD19 CAR T cells in vivo
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
Antitumor Effects
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Secondary Outcome Measures
Full Information
NCT ID
NCT04100187
First Posted
September 18, 2019
Last Updated
November 26, 2022
Sponsor
Kecellitics Biotech Company Ltd
Collaborators
Hebei Yanda Ludaopei Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04100187
Brief Title
Immunotherapy With CD19 CAR T-cells for B-Cell Leukemia
Official Title
Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kecellitics Biotech Company Ltd
Collaborators
Hebei Yanda Ludaopei Hospital
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
This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.
Detailed Description
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ Leukemia. Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR Tcells.
Patients will receive the CD19CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with high risk relapsed CD19+ Leukemia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
CAR-T, Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental:3
Arm Type
Experimental
Arm Description
Leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
Intervention Type
Biological
Intervention Name(s)
Anti-CD19-CAR
Intervention Description
Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
Primary Outcome Measure Information:
Title
Adverse events of each patient
Description
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Time Frame
3 years
Title
Survival time of Anti-CD19 CAR T cells in vivo
Description
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
Time Frame
3 years
Title
Antitumor Effects
Description
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Time Frame
Every 3 months post treatment up to 24 months
Title
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Description
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Time Frame
4 weeks
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:
Relapsed or refractory B cell Leukemia.
KPS>60.
Life expectancy>3 months.
Gender unlimited, age from 2 years to 70 years.
CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
Patients who have failed at least one line of a standard treatment.
No serious mental disorder.
Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
No other serious diseases(autoimmune disease, immunodeficiency etc.).
No other tumors.
Patients volunteer to participate in the research.
Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial
Exclusion Criteria:
KPS<50.
Patients are allergic to cytokines.
Uncontrolled active infection.
Acute or chronic GVHD.
Treated with T cell inhibitor.
Pregnancy and nursing females.
HIV/HBV/HCV Infection.
Other situations we think improper for the research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li xiangqun, DOCTOR
Phone
086-15712867910
Email
xiangqun_li@doingtimes.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li xiangqun
Phone
086-15712867910
Email
xiangqun_li@doingtimes.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li xiangqun
Organizational Affiliation
Kecellitics Biotech Company Ltd
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Immunotherapy With CD19 CAR T-cells for B-Cell Leukemia
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