MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma

Study Overview
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Brief Summary
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This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory B-cell lymphoma.

Detailed Description
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In this single-center, open-label, nonrandomized, no control, prospective clinical trial, appoximately 15 relapsed or refractory B-cell lymphoma patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-cell lymphoma

Official Title
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Study Evaluating the Efficacy and Safety of MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: MC-19PD1 CAR-T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: （1）CD19 positive B-cell lymphoma; （2）Relapsed and refractory B-cell lymphoma: patients previously received at least first-line and second- line treatment and fail to achieve CR; （3）At least 1 measurable tumor foci according to the 2014 Lugano treatment response criteria; （4）18 to 70 Years Old, Male and female; （5）Expected to survive for more than 3 months; （6）Clinical performance status of ECOG score 0-1; （7）Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%; serum Cr ≤ 1.25 times normal range or creatinine clearance calculated by Cockcroft-Gault formula ≥45ml/min; ALT and AST≤ 3 times normal range, total bilirubin ≤ 1.5times normal range; （8）hemoglobin ≥ 80 g / L, neutrophils ≥ 1.0 × 10 ^ 9 / L, platelets ≥ 50 × 10 ^ 9 / L. （9）INR≤ 1.5times normal range; APTT≤ 1.5times normal range; （10）Women in childbearing age must be not pregnant and do not plan pregnancy within 1 year of their cell transfusion; （11）Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: Recent or current use of glucocorticoid or other immunosuppressor or Drug that stimulates bone marrow hematopoiesis; Uncontrolled systemic active infection: fungi, bacteria, viruses or other infections; Active infection with HBV, HCV or HIV; Patients with symptoms and disease history of central nervous system; Pregnant or lactating female；The patient did not agree to use effective contraception during the treatment period and for the following 1 year； Patients receiving allogeneic hematopoietic stem cell transplantation, or organ transplantation A history of other malignant tumors; Primary immunodeficiency disease, or autoimmune disease; Patients treated with PD-1 inhibitors or PD-L1 inhibitors prior to enrollment; Patients who participated in other clinical trials within 4 weeks before blood collection; Patients who had used CD19 targeted therapy before enrollment; The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: MC-19PD1 CAR-T Cells<br> | Biological: MC-19PD1 CAR-T cells<br>* T cells purified from the PBMC of subjects, transduced with anti-CD19 CAR and PD1/CD28 chimera lentiviral vector, expanded in vitro for future administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of adverse events | Percentage of participants with adverse events | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective remission rate | The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR) | 3 months |