Immunotherapy With CD19 CAR T-cells for B-Cell Lymphoma, ALL and CLL
Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Malignancies
1 other identifier
interventional
100
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 leukemia
Started Mar 2021
Shorter than P25 for phase_1 leukemia
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedJanuary 26, 2021
January 1, 2021
1 year
September 8, 2015
January 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 years
Secondary Outcomes (3)
Survival time of Anti-CD19 CAR T cells in vivo.
3 years
Antitumor Effects
Every 3 months post treatment up to 24 months
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
4 weeks
Study Arms (3)
Experimental: 1
EXPERIMENTALAcute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
Experimental: 2
EXPERIMENTALChronic lymphoblastic leukemia with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
Experimental: 3
EXPERIMENTALNon-hodgkin lymphoma treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
Interventions
Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Doing Biomedical Co., Ltd.lead
- The First Hospital of Jilin Universitycollaborator
- Hebei Yanda Ludaopei Hospitalcollaborator
Study Sites (12)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, 065200, China
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Huai'An First People'S Hospital
Huaian, Jiangsu, 223300, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
First Hospital of Jilin University
Changchun, Jilin, 130021, China
Shanxi Dayi Hospital
Taiyuan, Shanxi, 030000, China
Tianjin people's hospital
Tianjin, Tianjin Municipality, 300121, China
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310002, China
Beijing DOING Biomedical Co., Ltd
Beijing, 100021, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
li gangyi, master
Beijing Doing Biomedical Co., Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2015
First Posted
September 11, 2015
Study Start
March 1, 2021
Primary Completion
March 1, 2022
Study Completion
March 1, 2023
Last Updated
January 26, 2021
Record last verified: 2021-01