Donor-derived Anti-CD123-CART Cells for Recurred AML After Allo-HSCT
Donor-derived Anti-CD123 Chimeric Antigen Receptors Modified T Cells for Recurred Acute Myeloid Leukaemia After Allogeneic Hematopoietic Stem Cell Transplantation
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Hu Chen, M.D., Ph.D.
- Phone Number: +86-010-6694-7108
- Email: chenhu217@aliyun.cn
Study Contact Backup
- Name: Bin Zhang, M.D., Ph.D.
- Phone Number: +86-010-6694-7125
- Email: zb307ctc@163.com
Study Locations
-
-
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Beijing Shi, China
- Recruiting
- Fengtai District
-
Contact:
- Hu Chen, M.D., Ph.D.
- Phone Number: +86-010-6694-7108
- Email: chenhu217@aliyun.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and Female subjects with CD123+ acute myeloid leukemia as confirmed by immunohistochemistry and flow cytometry;
- Patients must have received an allogenic stem cell transplantation(Allo-HSCT). The leukemia relapsed. There are available donor or enough cryopreserved donor-derived PBMCs for CART preparation and subsequent Allo-HSCT. In the previous case, the donor should have adequate venous access for apheresis.
- Karnofsky score greater than 70%;
- patients more than 18 years of age
- Expected survival time >16 weeks;
- Bilirubin <3.0 mg/dL,
- Alanine aminotransferase(ALT)/ aspartate aminotransferase(AST)<3 fold normal.
- Diffusing capacity of the lung for carbon monoxide(DLCO) and forced expiratory volume in one second(FEV1)>45% of predictive value.
- At least received three kinds of medicines functioning by different mechanisms, including alkylating agents, protease inhibitors, and immunomodulators, and disease progressing within 60 days.
- Important organs are well tolerated;
- For post-transplantation patients, the apheresis would be undertaken only at least 2 weeks after immunosuppressive agents for GvHD withdrawal;
- From very beginning of the test to 30 days after the withdrawal, men and women should adopt reliable contraceptive measures.
- All research participants must have the ability to understand and willingness to sign a written informed consent.
Exclusion criteria:
- Patients were diagnosed with APL M3:t(15; 17)(q22; q12);PML/RARα );
- Symptomatic active central nervous system leukaemia;
- Patients with HIV, hepatitis B or C infection;
- Any concurrent active malignancies;
- Other uncontrolled active illness that hinders participation in the trial;
- Patients suffer from coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage and other serious heart, cerebrovascular disease;
- patients with poorly controlled hypertensive
- patients with froward psychiatric history
- anyone who the researchers think unsuitable to participate in the investigation;
- anyone who long-term use of immunosuppressive agents for organ transplants or other reasons, or undertake inhaled corticosteroids therapy recently.
- failed production release testing: CAR+ T cells <30% or T cell expansion less than 5-fold under the CD3/28 beads stimulation.
- Pregnant, lactating or female patients planning to get pregnant within 2 months before treatment ends;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: CD123CAR-41BB-CD3zeta-EGFRt-expressing T cells
Patients will receive a full dose CART infusion at day 0.
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a single dose of CD123CAR-41BB-CD3zeta-EGFRt-expressing T cells will be infusion after preconditioning.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03
Time Frame: 15 years
|
15 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: 15 years
|
15 years
|
|
CART cells persistence in vivo
Time Frame: 15 years
|
15 years
|
|
CAR123-specific antibody level
Time Frame: 15 years
|
15 years
|
|
Disease response(CR, CRi)
Time Frame: 15 years
|
15 years
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Hu Chen, M.D., Ph.D., Affiliated Hospital to Academy of Military Medical Sciences, China
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 307-RV-CAR-123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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