CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma

Refractory Clinical Trial

Official title:

Clinical Study of CD19/CD20 Bispecific Nanobody-derived CAR-T Cells in Refractroy/Relasped B Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03881761
• Other study ID #: HenanCH CART 2-3
• Status: Recruiting
• Phase: Phase 1
• Start date: February 1, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: January 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 CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma

Description:

CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 70 Years

Eligibility

Inclusion Criteria:

• expected lifetime>3 months

• CD19/CD20 positive relapsed/refractory B cell lymphoma

• KPS>70

• at least one measurable lesion according to RECIST 1.1

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

• no history of severe allergies

• no other history of malignancy

• no other diseases that conflict with this regimen

• no serious mental illness

• patient or family member sign informed consent

Exclusion Criteria:

• Pregnant or lactating women

• Severe infectious or viral disease

• Active B or C viral hepatitis

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

• participated in other clinical studies in the last 3 months, or have been treated with other gene products

• Others not appropriate to participate in this study examined by the investigators

Related Conditions & MeSH terms

• B-Cell Lymphoma Stage I
• Lymphoma
• Lymphoma, B-Cell
• Refractory
• Relapsed

Intervention

Biological:
• CD19/CD20 bispecific CAR-T cells
collecting 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 CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg

Locations

Country	Name	City	State
China	Cancer Hospital Affiliate to Zhengzhou University & 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	proportion of patients with complete response and partial response	three months
Secondary	survival time of CAR-T cells in vivo	from the time of CAR-T cells transfusion to the first time that CAR-T cells could not be measured in vivo	one year
Secondary	progression-free survival	the enrollment to the first time that disease progression is detected	one year