CART-19 FOR Relapsed/Refractory Acute Lymphoblastic Leukemia （ALL）

Leukemia, Lymphocytic, Acute Clinical Trial

Official title:

CD19-Targeted CAR-T in Treating Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia （ALL）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03544021
• Other study ID #: CART-19 FOR ALL
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• Study type: Interventional

Clinical Trial Summary

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.

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.

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:

• 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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Acute
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• CART-19 cells
CD19-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 CD19+ CAR T cells		28 days
Secondary	CAR19-specific antibody level		6 months
Secondary	Duration of response		1year
Secondary	Progression Free Survival		1year
Secondary	Survival		1year