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

Lymphoma Clinical Trial

Official title:

The Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03468153
• Other study ID #: Ruijin-CAR-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 11, 2018
• Last updated: March 16, 2018
• Start date: January 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2018
• Source: Ruijin Hospital
• Contact: Weili Zhao, MD
• Phone: 64370045
• Email: zhao.weili[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy
Patient-derived dual specificity CD19 and CD22 CAR-T Cells

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall remission rate	Rate of complete remission and patial remission	4 weeks after infusion
Secondary	Adverse toxicity	According to CTCAE 4.0 criteria	Day 0, day 4, week 1, week 3, week 4, month 2, month 12 after CAR-T cells were infused