Safety and Efficacy Evaluation of IM19 CAR-T Cells
IM19CAR-T
1 other identifier
interventional
60
1 country
2
Brief Summary
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia or CD19+ B-all.
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 Aug 2016
Shorter than P25 for phase_1 leukemia
2 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
June 6, 2016
CompletedStudy Start
First participant enrolled
August 30, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedMay 1, 2018
October 1, 2017
1.8 years
June 6, 2016
April 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of study related adverse events
defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.
2 years
Secondary Outcomes (1)
Overall response rate
2 years
Study Arms (1)
IM19 CART
EXPERIMENTALA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of IM19CART cells administered intravenously.
Interventions
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.
Eligibility Criteria
You may qualify if:
- Patients with CD19+ leukemia, meeting the following criteria
- At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy)
- Less than 1 year between last chemotherapy and progression
- Not eligible or appropriate for allo-HSCT
- To be aged 4 to 65 years
- Estimated survival of ≥ 6 months, but ≤ 2 years
- ECOG score ≤2
- Relapse after auto-HSCT
- Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
- Voluntary participation in the clinical trials and sign the informed consent.
You may not qualify if:
- History of epilepsy or other CNS disease
- Patients have GVHD, which needs treatment with immunosuppressive agents
- Patients with prolonged QT interval or severe heart disease
- Patients in pregnancy or breast-feeding period
- Uncontrolled active infection
- Active hepatitis B or hepatitis C infection
- Previously treatment with any gene therapy products
- Feasibility assessment during screening demonstrates \<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation
- ALT /AST\>3 x normal value; Creatinine\> 2.5 mg/dl; Bilirubin \>2.0 mg/dl
- Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
- HIV infection
- Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beijing hospital
Beijing, China
Peking University People's Hospital (PKUPH)
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
hui liu, MD
Beijing Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2016
First Posted
May 5, 2017
Study Start
August 30, 2016
Primary Completion
June 1, 2018
Study Completion
October 1, 2018
Last Updated
May 1, 2018
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share