- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02546739
Immunotherapy With CD19 CAR T-cells for B-Cell Lymphoma, ALL and CLL
January 23, 2021 updated by: Beijing Doing Biomedical Co., Ltd.
Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Malignancies
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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+ haematological malignancies (Leukemia and lymphoma).
Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR T-cells.
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+ malignancies.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: gai liyun, doctor
- Phone Number: 086-13269099630
- Email: liyun_gai@doingtimes.com
Study Locations
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Beijing, China, 100021
- Beijing DOING Biomedical Co., Ltd
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Beijing
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Beijing, Beijing, China, 100142
- Beijing Cancer Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Hebei
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Sanhe, Hebei, China, 065200
- Hebei yanda Ludaopei Hospital
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Contact:
- Gai liyun, Doctor
- Phone Number: 086-13269099630
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Henan
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Luoyang, Henan, China, 471003
- First Affiliated Hospital of Henan University of Science and Technology
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Zhengzhou, Henan, China, 450052
- The First Affiliated hospital of Zhengzhou University
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Jiangsu
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Huaian, Jiangsu, China, 223300
- Huai'an First People's Hospital
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Nanjing, Jiangsu, China, 210008
- Nanjing Drum Tower Hospital
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Jilin
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Changchun, Jilin, China, 130021
- First Hospital of Jilin University
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Shanxi
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Taiyuan, Shanxi, China, 030000
- Shanxi Dayi Hospital
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Tianjin
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Tianjin, Tianjin, China, 300121
- Tianjin People's Hospital
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Contact:
- Li gangyi, Master
- Phone Number: 13601204100
- Email: gangyi_li@doingtimes.com
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Zhejiang
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Hangzhou, Zhejiang, China, 310002
- Hangzhou Cancer Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 18 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: 1
Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
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Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
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Experimental: Experimental: 2
Chronic lymphoblastic leukemia with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
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Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
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Experimental: Experimental: 3
Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
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Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events of each patient.
Time Frame: 3 years
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Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival time of Anti-CD19 CAR T cells in vivo.
Time Frame: 3 years
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To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
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3 years
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Antitumor Effects
Time Frame: Every 3 months post treatment up to 24 months
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Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
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Every 3 months post treatment up to 24 months
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Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Time Frame: 4 weeks
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Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Li gangyi, master, Beijing Doing Biomedical Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2021
Primary Completion (Anticipated)
March 1, 2022
Study Completion (Anticipated)
March 1, 2023
Study Registration Dates
First Submitted
September 8, 2015
First Submitted That Met QC Criteria
September 9, 2015
First Posted (Estimate)
September 11, 2015
Study Record Updates
Last Update Posted (Actual)
January 26, 2021
Last Update Submitted That Met QC Criteria
January 23, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Doing-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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