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

NCT03468153 | Unknown Phase 1

• 1 other identifier: Ruijin-CAR-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall remission rate

  Rate of complete remission and patial remission

  4 weeks after infusion

Secondary Outcomes (1)

• Adverse toxicity

  Day 0, day 4, week 1, week 3, week 4, month 2, month 12 after CAR-T cells were infused

Study Arms (1)

CAR-T cell therapy

EXPERIMENTAL

Patient-derived dual specificity CD19 and CD22 CAR-T

Biological: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy

Interventions

Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy BIOLOGICAL

Patient-derived dual specificity CD19 and CD22 CAR-T Cells

CAR-T cell therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd: collaborator

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Weili Zhao, MD

CONTACT

64370045; zhao.weili@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2018
• First Posted: March 16, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

CN (1)