Status:
SUSPENDED
CD19/CD20 Dual-CAR-T in B-cell Non-Hodgkin's Lymphoma Patients.
Lead Sponsor:
Beijing Tsinghua Chang Gung Hospital
Collaborating Sponsors:
China Immunotech Pharmaceuticals Co.Ltd.
Conditions:
B-cell Non-Hodgkin's Lymphoma
Eligibility:
All Genders
1-80 years
Phase:
EARLY_PHASE1
Brief Summary
This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory or relapsed B-NHL.
Detailed Description
This Phase I study is designed as a pilot trial evaluating the safety and efficacy of CD19/CD20 Dual-CAR-T cell therapy in subjects with refractory and relapsed B-NHL. Subjects will receive cytoreduct...
Eligibility Criteria
Inclusion
- Age ≥18 years
- NHL confirmed by cytology or histology, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, etc.
- Relapse or refractory after at least second-line treatment;
- With evaluable target lesions.Measurable target lesions: lymph nodes\>1.5x1.0cm, extranodal lesions\>1.0x1.0cm;
- Double positive expression of CD19 / CD20 in B cells;
- ECOG score 0-2 points;
- Good organ function:
- Blood routine: absolute neutrophil count (ANC) ≥1.0×109/L; hemoglobin (Hb) ≥80 g/L; platelet count (PLT) ≥50×109/L; Blood biochemistry: total bilirubin≤3×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3×upper limit of normal (ULN); Pulmonary function: ≤CTCAE Grade 1 dyspnea and SaO2≥92% in indoor air environment; Heart function: Left ventricular ejection fraction (LVEF) ≥50%.
- Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside;
- Patients who voluntarily sign informed consent and are willing to comply with treatment plans.
Exclusion
- Active infections that are difficult to control;
- Active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) antibody positive, and Treponema pallidum antibody test positive;
- The tumor invades the central nervous system or primary CNS lymphoma;
- Anti-GVHD (acute or chronic) treatment is being performed within 4 weeks before apheresis and cell infusion;
- Have undergone the following treatments:
- Those who have received chemotherapy or radiotherapy 5 days before apheresis;
- Those who have used drugs that stimulate the production of bone marrow hematopoietic cells within 5 days before apheresis;
- Received donor lymphocyte infusion (DLI) within 6 weeks before cell infusion;
- Have received autologous hematopoietic stem cell transplantation (HSCT) 3 months before apheresis, or received allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 12 months;
- Have used any gene therapy products before;
- History of epilepsy or other central nervous system diseases; or clinically diagnosed as having severe thyroid dysfunction; or active autoimmune diseases;
- History of other malignant tumors that have not been remission for at least 3 years ;
- Any of the following cardiovascular diseases occurred within 6 months of the screening period, including NYHA heart function grade III or IV heart failure, cardiovascular angioplasty or stent, myocardial infarction, unstable angina, or other clinical symptoms Significant heart disease;
- Pregnant or lactating women;
- The investigator believes that there are other factors that are not suitable for selection or that affect subjects' participation or completion of the study.
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 10 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04697290
Start Date
March 10 2022
End Date
June 10 2023
Last Update
February 14 2022
Active Locations (1)
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1
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China