Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma

Phase 1

• Conditions: Lymphoma
• Interventions: Biological: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy

• Registration Number: NCT03468153
• Lead Sponsor: Ruijin Hospital

Brief Summary

Patients with relapsed or refractory lymphoma often develop resistance to chemotherapy. Chimeric antigen receptor-modified T cell (CART) therapy showed promising effect in B-cell malignancies these years. CD19 and CD22 are proteins expressed on the surface of the lymphoma cells in patients with CD19+CD22+ lymphoma. The CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22. This is a phase 2 trial to study the safety and efficacy of dual specificity CD19 and CD22 CAR-T cell immunotherapy for CD19+CD22+ relapsed and refractory lymphoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-03
• Study First Submitted: 2018-03-11
• Study First Submitted QC: 2018-03-11
• Study First Posted: 2018-03-16
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-20
• Primary Completion: 2019-01-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Histological detection confirmed CD19/CD22 postive lymphoma;
• Recieved more than 2 lines of chemotherapy;
• Not eligible for hematopoietic stem cell transplantation or relapsed after hematopoietic stem cell transplantation;
• Life expectation for more than 3 months;
• ECOG ≥ 2;
• Adequate organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT < 2 × upper limitation of normal; SpO2 > 92%;
• CBC results: Hb ≥ 80g/L, ANC > 1 × 10E9/L, Plt ≥ 50 × 10E9/L;
• Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion;
• With measurable disease;
• Written informed consent could be acquired;

Exclusion Criteria

• Immunosuppressive agents or steroids in recent 1 week before recruitment;
• Uncontrolled infection;
• HIV positive ;
• Active HBV or HCV infection;
• Women in pregnancy and lactation;
• Refuse to conception control during treatment and 1 year after CAR-T infusion;
• Uncured malignancies other than non-Hodgkin lymphoma;
• Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma;
• Inheritated immune deficiancy;
• Severe heart disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR-T cell therapy	Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy	Patient-derived dual specificity CD19 and CD22 CAR-T

Primary Outcome Measures

Name	Time	Method
Overall remission rate	4 weeks after infusion	Rate of complete remission and patial remission

Secondary Outcome Measures

Name	Time	Method
Adverse toxicity	Day 0, day 4, week 1, week 3, week 4, month 2, month 12 after CAR-T cells were infused	According to CTCAE 4.0 criteria

Trial Locations

Locations (1)

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China