Immunotherapy With CD22 CAR T-cells for B-Cell Lymphoma, ALL and CLL
Primary Purpose
Leukemia, Lymphoma
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
:Anti-CD22-CAR
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring CAR-T, Leukemia, lymphoma
Eligibility Criteria
Inclusion Criteria:
- Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
- KPS>60.
- Life expectancy>3 months.
- Gender unlimited, age from 2 years to 70 years.
- CD22 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
Exclusion Criteria:
- KPS<50.
- Patients are allergic to cytokines.
- Central nervous system leukemia within 28 days.
- 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 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
experimental:1
experimental:2
experimental:3
Arm Description
Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22.
Chronic lymphoblastic leukemia with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22.
Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22.
Outcomes
Primary Outcome Measures
Adverse events of each patient
Determine the toxicity profile of the CD22 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
Survival time of Anti-CD22 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 CD22 targeted CAR T cells.
Maximum tolerated dose (MTD) of CD22 targeted CAR T cells.
Secondary Outcome Measures
Full Information
NCT ID
NCT04163575
First Posted
November 12, 2019
Last Updated
December 20, 2019
Sponsor
Kecellitics Biotech Company Ltd
Collaborators
Hebei Yanda Ludaopei Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04163575
Brief Title
Immunotherapy With CD22 CAR T-cells for B-Cell Lymphoma, ALL and CLL
Official Title
Phase I Study of T Cells Expressing an Anti-CD22 Chimeric Receptor in Children and Young Adults With B Cell Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (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 CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD22+ 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 CD22 Chimeric Antigen Receptor (CAR) T-cells (CD22 CAR T-cells) in patients with high risk, relapsed CD22+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD22 CAR Tcells. Patients will receive the CD22CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD22 CAR T-cells in patients with high risk relapsed CD22+ malignancies
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
CAR-T, Leukemia, lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental:1
Arm Type
Experimental
Arm Description
Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22.
Arm Title
experimental:2
Arm Type
Experimental
Arm Description
Chronic lymphoblastic leukemia with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22.
Arm Title
experimental:3
Arm Type
Experimental
Arm Description
Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22.
Intervention Type
Biological
Intervention Name(s)
:Anti-CD22-CAR
Intervention Description
Cells extracted, followed by induction chemotherapy before CD22-CAR infusion (dose escalation.)
Primary Outcome Measure Information:
Title
Adverse events of each patient
Description
Determine the toxicity profile of the CD22 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
Time Frame
3 years
Title
Survival time of Anti-CD22 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 CD22 targeted CAR T cells.
Description
Maximum tolerated dose (MTD) of CD22 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 derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
KPS>60.
Life expectancy>3 months.
Gender unlimited, age from 2 years to 70 years.
CD22 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
Exclusion Criteria:
KPS<50.
Patients are allergic to cytokines.
Central nervous system leukemia within 28 days.
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
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 CD22 CAR T-cells for B-Cell Lymphoma, ALL and CLL
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