Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma

Refractory Chronic Lymphocytic Leukemia Clinical Trial

Official title:

A Phase I Study of Administrating CD19 Chimeric Antigen Receptor Expressing T Cells Followed by Allogeneic Stem Cell Transplantation in Patients With Refractory CD19+ B-linage Leukemia/Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03110640
• Other study ID #: 20170316
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2016
• Est. completion date: September 2021

Study information

• Verified date: November 2019
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: Kang Yu, M.D.
• Phone: 55578037
• Email: yukang62[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.

Description:

Primary objectives

1. To determine the safety and feasibility of allogeneic stem cell transplantation combined with adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives

2. To measure the efficacy of the CD19CAR T cell infusion combined with allogeneic stem cell transplantation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 70 Years

Eligibility

Inclusion Criteria:

• 5 Years to 70 Years, Male and female;

• Expected survival > 12 weeks;

• Performance score 0-2;

• Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions; Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; Disease recurrence after stem cell transplantation; Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy

• Creatinine < 2.5 mg/dl;

• ALT/AST < 3x normal;

• Bilirubin < 2.0 mg/dl;

• Adequate venous access for apheresis, and no other contraindications for leukapheresis;

• Take contraceptive measures before recruit to this trial;

• Written voluntary informed consent is given.

Exclusion Criteria:

• Patients with symptoms of central nervous system

• Accompanied by other malignant tumor

• Active hepatitis B or C, HIV infection

• Any other diseases could affect the outcome of this trial

• Suffering severe cardiovascular or respiratory disease

• Poorly controlled hypertension

• A history of mental illness and poorly controlled

• Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration

• Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment

• Reaching a steady dose if receiving anticoagulant therapy before assignment

• Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion

• Pregnant or lactating women

• Subject suffering disease affects the understanding of informed consent or comply with study protocol.

Related Conditions & MeSH terms

• Adult Acute Lymphoblastic Leukemia in Remission
• B-cell Adult Acute Lymphoblastic Leukemia
• B-cell Chronic Lymphocytic Leukemia
• Hematopoietic/Lymphoid Cancer
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Refractory Chronic Lymphocytic Leukemia

Intervention

Biological:
• anti-CD19 CAR-T
Ex vivo-expanded autologous T cells modified to express CD19 CAR

Drug:
• Fludarabine
Patients were given cyclophosphamide 500mg/m2/day on day -4 and fludarabine at 25 mg/m2/day on day -4, day -3, and day -2.
• Cyclophosphamide
Patients were given cyclophosphamide 500mg/m2/day on day -4.

Locations

Country	Name	City	State
China	The First Affilicated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
First Affiliated Hospital of Wenzhou Medical University	Hrain Biotechnology Co., Ltd., Second Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - incidence of adverse events defined as dose-limited toxicity	incidence of adverse events defined as dose-limited toxicity	180 days
Secondary	Overall complete remission rate	Overall complete remission rate	1 year
Secondary	Duration of remission	Duration of remission	1 year