Clinical Study of Autologous Stem Cell Transplantation + Anti-CD19 CAR T Cells for B-cell Lymphoma

NCT05755828 | Unknown Phase 2

• 1 other identifier: XYFY2022-KL480-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the CR rate of B-NHL subjects who achieved PR at intermediate assessment after first-line chemotherapy treated with autologous stem cell transplantation + Anti-CD19 CAR T cells.

Conditions

B-cell Lymphoma

Keywords

Anti-CD19 CAR-T; Autologous stem cell transplantation; Combination therapy

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  Proportion of enrolled patients who achieved complete response after treatment

  From 3 months to 1 year.

Secondary Outcomes (2)

• overall survival

  From 3 months to 1 year.

• Progression-free survival

  From 3 months to 1 year.

Study Arms (1)

ASCT+CAR-T Cell Infusion

EXPERIMENTAL

CD19 CAR-T cells were prepared from peripheral lymphocytes of NHL patients with PR after 3 to 4 courses of chemotherapy, and autologous stem cells were collected and frozen after mobilization of patient stem cells by granulocyte stimulating factor (10μg/kg/d\*5d). BEAM pretreatment was performed. Autologous stem cells were injected 24 h after pretreatment, and the number of CD34+ cells was \> 2\*106/kg. On the 6th day after transplantation, autologous Anti-CD19 CAR T cells were transfused, and the dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. The patients were given constant intravenous drip/push infusion for 30 minutes.

Biological: ASCT+CAR-T Cell Infusion

Interventions

ASCT+CAR-T Cell Infusion BIOLOGICAL

CD19 CAR-T cells were prepared from peripheral lymphocytes of NHL patients with PR after 3 to 4 courses of chemotherapy, and autologous stem cells were collected and frozen after mobilization of patient stem cells by granulocyte stimulating factor (10μg/kg/d\*5d). BEAM pretreatment was performed. Autologous stem cells were injected 24 h after pretreatment, and the number of CD34+ cells was \> 2\*106/kg. On the 6th day after transplantation, autologous Anti-CD19 CAR T cells were transfused, and the dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. The patients were given constant intravenous drip/push infusion for 30 minutes.

ASCT+CAR-T Cell Infusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients or their legal guardians voluntarily participate and sign the informed consent;
• Male or female patients aged 18-70 years (including 18 and 70 years);
• CD19+ B-NH was confirmed by pathology and histology, and the patient achieved a partial response (PR) by interim assessment after 3-4 courses of first-line chemotherapy;
• B-cell non-Hodgkin lymphoma mainly includes the following two types:
• (1) Diffuse large B-cell lymphoma (DLBCL); Mantle cell lymphoma (MCL); 5. Measurable or evaluable lesions; 6. The patient's main tissues and organs function well:
• Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L;
• Renal function: creatinine \< 220μmol/L;
• Lung function: indoor oxygen saturation ≥95%;
• Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. 7. The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous infusion; 8. Patients with ECOG score ≤2 and expected survival time ≥3 months.

You may not qualify if:

• Women who are pregnant (urine/blood pregnancy test positive) or breastfeeding;
• Men or women who have planned to become pregnant within the last 1 year;
• The patients were not guaranteed to take effective contraceptive measures (condoms or contraceptives, etc.) within 1 year after enrollment;
• Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment;
• Active hepatitis B/C virus;
• Hiv-infected patients;
• Suffering from a serious autoimmune disease or immunodeficiency disease;
• The patient is allergic to antibodies, cytokines and other macromolecular biological drugs;
• The patient had participated in other clinical trials within 6 weeks prior to enrollment;
• Systemic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);
• Suffers from mental illness;
• The patient has substance abuse/addiction;

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221002, China

RECRUITING

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

Central Study Contacts

Wei Sang, M.D., Ph.D.

CONTACT

13645207648; xyfylbl515@xzhmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 6, 2023
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)