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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAR-T cell therapy<br>Patient-derived dual specificity CD19 and CD22 CAR-T | Biological: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy<br>* Patient-derived dual specificity CD19 and CD22 CAR-T Cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall remission rate | Rate of complete remission and patial remission | 4 weeks after infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |