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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03556982
Other study ID # CART-123 FOR AML
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 1, 2018
Est. completion date March 1, 2020

Study information

Verified date March 2018
Source The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Contact HUISHENG AI
Phone 8610-66947126
Email HUISHNGAI@163.COM
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficiency of CD123-Targeted CAR-T in Treating Patients with relapsed/refractory AML


Description:

The relapsed/refractory AML patients will receive FC (F,Fludarabine,C,Cyclophosphamide) chemotherapy followed by infusion of allogenic or autologous CD123-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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date March 1, 2020
Est. primary completion date March 1, 2019
Accepts healthy volunteers No
Gender All
Age group 14 Years to 75 Years
Eligibility Inclusion Criteria:

- CD123-expressing AML 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

- CD123 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
CART-123 cells
CD123-Targeted CAR-T cells are infused to patient received FC chemotherapy

Locations

Country Name City State
China 307 Hospital of PLA Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose-limiting toxicity 28 days
Primary Incidence of adverse events as assessed 3 months
Primary Disease response (CR or CRi) 3 months
Secondary Engraftment of transferred CD123+ CAR T cells 28 days
Secondary CAR123-specific antibody level 6 months
Secondary Duration of response 1year
Secondary Progression Free Survival 1year
Secondary Survival 1year
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