CD19/CD20 Dual-CAR-T in B-cell Non-Hodgkin's Lymphoma Patients.

NCT04697290 | Suspended Early Phase 1

• 1 other identifier: HXYT-012
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

B-cell Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (2)

• Percentage of adverse events

  Percentage of participants with adverse events.

  6months

• Objective remission rate(ORR)

  The percentage of participants who achieved complete remission (CR) and partial remission over all participants.

  6 months

Secondary Outcomes (2)

• Relapse-Free Survival(RFS )

  6 months

• Overall-Survival(OS)

  6 months

Other Outcomes (1)

• Persistence of CAR-T cells in vivo

  6 months

Study Arms (1)

CD19/CD20 Dual-CAR-T cells

EXPERIMENTAL

CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for at least 2 days before infusion.

Biological: CD19/CD20 Dual-CAR-T cells

Interventions

CD19/CD20 Dual-CAR-T cells BIOLOGICAL

CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest at least for 2 days before infusion. CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 2E6、6E6、1E7、3E7 cells/kg.

CD19/CD20 Dual-CAR-T cells

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead
• China Immunotech Pharmaceuticals Co.Ltd.: collaborator

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 6, 2021
• Study Start: March 10, 2022
• Primary Completion: March 10, 2023
• Study Completion: June 10, 2023
• Last Updated: February 14, 2022

Record last verified: 2022-01

Locations

CN (1)