- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03544021
CART-19 FOR Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)
May 31, 2018 updated by: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
CD19-Targeted CAR-T in Treating Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)
The purpose of this study is to evaluate the safety and efficiency of CD19-Targeted CAR-T in Treating Patients with relapsed/refractory acute leukemia.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The relapsed/refractory ALL patients will receive FC (F,Fludarabine,C,Cyclophosphamide) chemotherapy followed by infusion of allogenic or autologous CD19-Targeted CAR-T cells.No graft-versus-host disease (GVHD) prevention will be conducted before or after infusion.
Dose-limiting toxicity,incidence of adverse events and disease response will be detected post-infusion.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 2
- 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: HUISHENG AI
- Phone Number: 8610-66947126
- Email: HUISHNGAI@163.COM
Study Contact Backup
- Name: MEI GUO
- Phone Number: 8610-66947135
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100071
- Recruiting
- 307 Hospital of PLA
-
-
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
14 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- CD19-expressing ALL must be assured and must be relapsed or refractory disease. According to current traditional therapies, there must be no available alternative curative therapies and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have disease activity that prohibits SCT at this time.
- Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- CD19 expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry
- Patients must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis.
- Patients must have an healthy donor for T cells.
- Cardiac function: Left ventricular ejection fraction greater than or equal to 40% by MUGA or cardiac MRI, or fractional shortening greater than or equal to 28% by ECHO or left ventricular ejection fraction greater than or equal to 50% by ECHO.
- Renal function: Creatinine level of peripheral blood is required no greater than 133umol/L.
- Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus.
- Patients with history of allogeneic stem cell transplantation are eligible if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
- Ability to give informed consent.
Exclusion Criteria:
- Evident signs suggesting that patients are potentially allergic to cytokines.
- Frequent infection history and recent infection is uncontrolled.
- Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome.
- Active acute or chronic graft-versus-host disease (GVHD) or requirement of immunosuppressant medications for GVHD within 4 weeks of enrollment.
- Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
- Pregnancy and nursing females.
- HIV infection.
- Active hepatitis B or active hepatitis C.
- Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation. Participation in non-therapeutic research studies is allowed.
- Patients with a known history or prior diagnosis of other serious immunologic, malignant or inflammatory disease.
- Other situations we think not eligible for participation in 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CART-19
The relapsed/refractory ALL patients will receive allogenic or autologous CD19-Targeted CAR-T cells infusion after FC chemotherapy.
|
CD19-Targeted CAR-T cells are infused to patient received FC chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose-limiting toxicity
Time Frame: 28 days
|
28 days
|
Incidence of adverse events as assessed
Time Frame: 3 months
|
3 months
|
Disease response (CR or CRi)
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of response
Time Frame: 1year
|
1year
|
Progression Free Survival
Time Frame: 1year
|
1year
|
Survival
Time Frame: 1year
|
1year
|
Engraftment of transferred CD19+ CAR T cells
Time Frame: 28 days
|
28 days
|
CAR19-specific antibody level
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: HUISHENG AI, 307 Hospital of PLA
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 (Actual)
March 1, 2018
Primary Completion (Anticipated)
March 1, 2019
Study Completion (Anticipated)
March 1, 2020
Study Registration Dates
First Submitted
May 22, 2018
First Submitted That Met QC Criteria
May 22, 2018
First Posted (Actual)
June 1, 2018
Study Record Updates
Last Update Posted (Actual)
June 4, 2018
Last Update Submitted That Met QC Criteria
May 31, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CART-19 FOR ALL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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