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
1 other identifier
interventional
20
1 country
1
Brief Summary
Patients with acute myeloid leukemia(AML) recurred after the allogeneic hematopoietic stem cell transplantation (allo-HSCT) have a dismal prognosis.The investigators developed donor-derived chimeric antigen receptor modified-T cell(CART) to target CD123 for the treatment of AML. The investigators start the Phase I study aimed to treat recurred post-transplantation AML patients using donor-derived CAR-T. The purpose of this study is to assess the safety and effectiveness of anti-CD123 CAR-T cells in patients.
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 Mar 2017
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
First Submitted
Initial submission to the registry
March 21, 2017
CompletedStudy Start
First participant enrolled
March 25, 2017
CompletedFirst Posted
Study publicly available on registry
April 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2021
CompletedJune 14, 2017
June 1, 2017
2 years
March 21, 2017
June 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03
15 years
Secondary Outcomes (4)
CART cells persistence in vivo
15 years
CAR123-specific antibody level
15 years
Overall survival
15 years
Disease response(CR, CRi)
15 years
Study Arms (1)
CD123CAR-41BB-CD3zeta-EGFRt-expressing T cells
EXPERIMENTALPatients will receive a full dose CART infusion at day 0.
Interventions
a single dose of CD123CAR-41BB-CD3zeta-EGFRt-expressing T cells will be infusion after preconditioning.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fengtai District
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hu Chen, M.D., Ph.D.
Affiliated Hospital to Academy of Military Medical Sciences, China
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
- Affiliated Hospital to Academy of Military Medical Sciences
Study Record Dates
First Submitted
March 21, 2017
First Posted
April 14, 2017
Study Start
March 25, 2017
Primary Completion
March 18, 2019
Study Completion
March 18, 2021
Last Updated
June 14, 2017
Record last verified: 2017-06