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

NCT03544021 | Unknown Phase 1 DMC

• 1 other identifier: CART-19 FOR ALL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia, Lymphocytic, Acute

Keywords

Acute Lymphocytic Leukemia; Relapsed; Refractory

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity

  28 days

• Incidence of adverse events as assessed

  3 months

• Disease response (CR or CRi)

  3 months

Secondary Outcomes (5)

• Engraftment of transferred CD19+ CAR T cells

  28 days

• CAR19-specific antibody level

  6 months

• Duration of response

  1year

• Progression Free Survival

  1year

• Survival

  1year

Study Arms (1)

CART-19

EXPERIMENTAL

The relapsed/refractory ALL patients will receive allogenic or autologous CD19-Targeted CAR-T cells infusion after FC chemotherapy.

Biological: CART-19 cells

Interventions

CART-19 cells BIOLOGICAL

CD19-Targeted CAR-T cells are infused to patient received FC chemotherapy

CART-19

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The Affiliated Hospital of the Chinese Academy of Military Medical Sciences: lead

Study Sites (1)

307 Hospital of PLA

Beijing, Beijing 100071, 100071, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• HUISHENG AI

  307 Hospital of PLA

  STUDY CHAIR

Central Study Contacts

HUISHENG AI

CONTACT

8610-66947126; HUISHNGAI@163.COM

MEI GUO

CONTACT

8610-66947135

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 1, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: June 4, 2018

Record last verified: 2018-03

Locations

CN (1)