Competitive Transfer of αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T Cells for B-cell Leukemia/Lymphoma
MatchCART
A Phase I/II Study of Competitive Transfer of αCD19-TCRz-CD28 and αCD19-TCRz-CD137 Chimeric Antigen Receptor T-Cells in Patients With Refractory CD19+ B-lineage Leukemia/Lymphoma
1 other identifier
interventional
20
1 country
1
Brief Summary
This is a single-arm open-label phase I/II study to determine the relative superiority of αCD19-TCRζ-CD28 and αCD19-TCRζ-CD137 CAR-T Cells in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma. Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically against cancer cells, has emerged as a promising therapeutic strategy. Clinical trials utilizing CARs against B cell malignancies have demonstrated remarkable potential. In this trial, all subjects will be competitively infused with αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T cells in equal number to test a hypothesis that CD137-costimulation can promote the persistence and engraftment of CAR-T cells and this superiority can lead to improved progression-free survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2016
Longer than P75 for phase_1
1 active site
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
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 14, 2016
CompletedFirst Posted
Study publicly available on registry
February 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 16, 2017
March 1, 2017
1.8 years
February 14, 2016
March 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Safety (incidence of adverse events defined as dose-limited toxicity)
30 days
Secondary Outcomes (4)
Overall complete remission rate
8 weeks
Survival of CAR T cells in circulation measured by flow cytometry and PCR
1 year
Duration of remission
1 year
Overall survival
1 year
Study Arms (1)
Mixed CD19CAR transfer
EXPERIMENTALAll subjects will be infused with αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T cells in equal number
Interventions
Ex vivo-expanded autologous T cells modified to express CD19 CAR
Eligibility Criteria
You may qualify if:
- Years to 70 Years, Male and female;
- Expected survival \> 12 weeks;
- Performance score 0-2;
- Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions;
- Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment;
- Disease recurrence after stem cell transplantation;
- Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy
- Creatinine \< 2.5 mg/dl;
- ALT/AST \< 3x normal;
- Bilirubin \< 2.0 mg/dl;
- Adequate venous access for apheresis, and no other contraindications for leukapheresis;
- Take contraceptive measures before recruit to this trial;
- Written voluntary informed consent is given.
You may not qualify if:
- Patients with symptoms of central nervous system
- Accompanied by other malignant tumor
- Active hepatitis B or C, HIV infection
- Any other diseases could affect the outcome of this trial
- Suffering severe cardiovascular or respiratory disease
- Poorly controlled hypertension
- A history of mental illness and poorly controlled
- Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration
- Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
- Reaching a steady dose if receiving anticoagulant therapy before assignment
- Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
- Pregnant or lactating women
- Subject suffering disease affects the understanding of informed consent or comply with study protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henan Province of TCM
Zhengzhou, Henan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhi Cheng, M.D.
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Hematology
Study Record Dates
First Submitted
February 14, 2016
First Posted
February 19, 2016
Study Start
February 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2019
Last Updated
March 16, 2017
Record last verified: 2017-03