Clinical Study of Anti-CD56-CAR-T in the Treatment of Relapsed/Refractory NK/T Cell Lymphoma /NK Cell Leukemia

NCT05941156 | Recruiting Phase 2

• 1 other identifier: XYFY2023-KL123-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of anti-CD56-CAR T in the treatment of relapsed refractory NK/T cell lymphoma /NK cell leukemia

Conditions

Extranodal NK T Cell Lymphoma; NK-Cell Leukemia

Keywords

Anti-CD56 CAR-T

Outcome Measures

Primary Outcomes (5)

• Overall response rate (ORR)

  CR+PR.1.Leukemia:Complete Response (CR):Bone marrow blast cells \<5%; primitive cells without Auer bodies; without extramedullary leukemia;Absolute blood neutrophil count was\> 1.0\*10\^9 / L (1000 / μ L);Platelet count\> 100\*10\^9 / L (100 000 / μ L);Not dependent on RBC infusion.Partial Response (PR):Only for Phase I and II clinical trials;Bone marrow cells were reduced to 5 - 25% and at least 50% compared with before treatment;Hematological parameters met the same criteria for CR. 2.Lymphoma:CR:All the evidence of the lesions disappeared.PR:The lymph nodes shrank with no new lesions.

  From 1 month to 1 year.

• progression-free survival (PFS)

  The time between treatment and observation of disease progression or death from any cause.

  From 1 month to 1 year.

• overall survival (OS)

  The time from the start of treatment to death from any cause.

  From 1 month to 1 year.

• event-free survival (EFS)

  The time between the start of treatment and the occurrence of any event, including disease recurrence, death, and so on.

  From 1 month to 1 year.

• Safety evaluation index

  1\. Detection of CRS-related factors: such as IFN, IL-6, TNF, IL-10, IL-4, CRP, etc;2. Testing of various laboratory items: blood routine, coagulation function, blood film observation, liver function, renal work, electrolytes, blood glucose, cardiac enzymes, blood cells, T cell subsets, immunoglobulins, etc;3.Adverse events and serious adverse events were observed.

  From 1 month to 1 year.

Secondary Outcomes (1)

• CAR T cell index of correlation

  From 1 month to 1 year.

Study Arms (1)

CAR-T Cell Infusion

EXPERIMENTAL

Pretreatment was initiated at -5 days prior to CAR T cell reinfusion, and CAR T cell therapy was performed 2 days after completion of chemotherapy. All patients were pretreated with FC regimen, fludarabine: 30mg/m2×3 days, cyclophosphamide: 750mg/m2×1 day. Anti CD56-CAR T cells were transfused back 2 days after chemotherapy. The freeze-thawed cell product solution is injected back into the body as soon as the patient can accept it. The patient's vital signs should be closely monitored throughout the infusion, and oxygen saturation should be measured at 15-minute intervals before, at the end of, and after infusion, and continue until the patient is stable. 30 to 60 minutes before CAR T cell infusion, patients were given 325 to 650 mg of acetaminophen orally to prevent infusion-related reactions; If fever occurred on the day of CAR T cell infusion, lasted less than 24 hours, and had no other toxicity, it was attributed to the infusion T cell response.

Biological: Anti-CD56 CAR T

Interventions

Anti-CD56 CAR T BIOLOGICAL

CAR T cells were pretreated at -5 days before retransfusion (FC regimen: fludarabine: 30mg/m2×3 days, cyclophosphamide: 750mg/m2×1 day). Anti CD56-CAR T cells were transfused back to the patient 2 days after the end of chemotherapy. 30 to 60 minutes before CAR T cell infusion, patients were given 325 to 650 mg of acetaminophen orally to prevent infusion-related reactions; If fever occurred on the day of CAR T cell infusion, lasted less than 24 hours, and had no other toxicity, it was attributed to the infusion T cell response.

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);
• The patient was diagnosed as NK/T cell lymphoma /NK cell leukemia by pathology or flow cytometry, and currently has no effective treatment options, such as relapse after chemotherapy or hematopoietic stem cell transplantation; Alternatively, patients voluntarily choose to administer anti-CD56-CAR T cells as salvage therapy.
• The following two categories are included:(1)NK/T cell lymphoma;(2) NK cell leukemia.
• Subject:
• (1)There was no remission or residual lesions after treatment, and HSCT (auto/allo-HSCT) was not suitable; (2)Relapse occurred after CR, and HSCT (auto/allo-HSCT) was not suitable; (3)Patients with high risk factors; (4)Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy.
• \. Measurable or evaluable lesions;
• \. 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 \< 220 μmol/L;
• Lung function: indoor oxygen saturation ≥95%;
• Cardiac function: left ventricular ejection fraction (LVEF) ≥40%.
• \. The patients had not received any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) within the first 4 weeks of enrollment, and their previous treatment-related toxic reactions had recovered to ≤ grade 1 at the time of enrollment (except low toxicity such as hair loss);
• \. The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous infusion;
• \. 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, Extranodal NK-T-Cell; Leukemia, Large Granular Lymphocytic

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Leukemia, T-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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: May 17, 2023
• First Posted: July 12, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)