Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies

B Cell Lymphoma Clinical Trial

Official title:

Clinical Study of Cord Blood Derived CAR-T Cells in Patients With Refractory/Relapsed B Cell Leukemia/Lymphoma Who Are Failed for Autologous CAR-T Cells or Autologous CAR-T Can Not be Prepared

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03881774
• Other study ID #: HenanCH CART 2-4
• Status: Recruiting
• Phase: Phase 1
• Start date: February 27, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: March 2019
• Source: Henan Cancer Hospital
• Contact: Yongping Song, Dr.
• Phone: +86-37165587795
• Email: songyongping2018[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation the safety and efficacy of cord blood-derived CAR-T cells in patients with relapsed/refractory B cell leukemia/lymphoma whose disease relapsed after autologous CAR-T cells therapy or who fail to preparation for autologous CAR-T cells

Description:

CAR-T cells therapy is the preferred option for relapsed/refractory B cell leukemia/lymphoma. However, some patients will relapse after CAR-T cells therapy, and because of previous multicycles chemotherapy it's very difficult to abtain enough lymphocytes for preparation of antologous CAR-T cells. The exploration of alternative source of lymphocytes for CAR-T cells preparation has important clinical implications for such patients. We evaluated the efficacy and safety of cord blood-derived CAR-T cells in such patients, and to explore effective treatment options for such patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 70 Years

Eligibility

Inclusion Criteria:

• expected lifespan >3 months

• patients with refractory/relapsed B cell leukemia/lymphoma whose diseases relapse after autologous CAR-T cells or the preparation for autologous CAR-T cells fails

• KPS >70

• for patients with lymphoma, at least one measurable lesion according to RECIST 1.1

• enough function of heart, liver, kidney and bone marrow

• no history of severy allergy

• no other serious diseases that conflict with this plan

• no other history of malignancy

• no serious mental illness

• patients and their families members agree to participate in this clinical study and sign the Informed Consent Form

Exclusion Criteria:

• pregnant or lactating women

• vevere infectious or viral diseases

• active hepatitis B or C viral hepatitis

• Patients who have used large amounts of glucocorticoids or other immunosuppressive agents within the last 4 weeks

• participated in other clinical studies in the past 3 months or who have been treated with other gene products;

• others that other investigators consider not suitable for this clinical study

Related Conditions & MeSH terms

• B Cell Leukemia
• B Cell Lymphoma
• Leukemia
• Leukemia, B-Cell
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, B-Cell
• Refractory
• Relapsed

Intervention

Biological:
• CAR-T cells
collecting cord blood for CAR-T cells culture; three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CAR-T cell with a dose of 0.5-3x106/kg

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Henan Cancer Hospital	Henan Hualong Biotechnology Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of study related adverse events	safety of CAR-T cells	one year
Secondary	objective response rate	the proportion of patients with CR or PR	three months
Secondary	progression-free survival	from the date of enrollment to the first date of progression detected	one year
Secondary	overall survival	from the date of enrollment to the date of death	one year
Secondary	copy number of CAR-T	copy number of CAR-T in blood and bone marrow	six months