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

Phase 1

• Conditions: Refractory; B-Cell Lymphoma Stage I; Relapsed
• Interventions: Biological: CD19/CD20 bispecific CAR-T cells

• Registration Number: NCT03881761
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma

Detailed 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.

Study Timeline

• Status Verified: 2019-01
• Study Start: 2019-02-01
• Study First Submitted: 2019-03-16
• Study First Submitted QC: 2019-03-16
• Study First Posted: 2019-03-19
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21
• Primary Completion: 2021-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental arm	CD19/CD20 bispecific CAR-T cells	CAR-T cell group

Primary Outcome Measures

Name	Time	Method
occurrence of study related adverse events	one year	safety of CAR-T cells

Secondary Outcome Measures

Name	Time	Method
objective response rate	three months	proportion of patients with complete response and partial response
progression-free survival	one year	the enrollment to the first time that disease progression is detected
survival time of CAR-T cells in vivo	one year	from the time of CAR-T cells transfusion to the first time that CAR-T cells could not be measured in vivo

Trial Locations

Locations (2)

Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China