Treatment of relapsed NK/T cell lymphoma with Anti-CD56 CAR-T therapy

Single-center, Open, One-arm Clinical Study of the Safety and Efficacy of Anti-CD56-CAR T Therapy in Relapsed Refractory NK/T Cell Lymphoma /NK Cell Leukemia

This study is testing a new CAR T cell therapy for people with relapsed NK/T cell lymphoma and NK cell leukemia to see if it can help them feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Affiliated Hospital of Xuzhou Medical University (Academic / other)
• Drugs / interventions: CAR T, chemotherapy, immunotherapy
• Locations: 1 site (Xuzhou, Jiangsu)
• Trial ID: NCT05941156 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and efficacy of Anti-CD56 CAR T cell therapy for patients with relapsed or refractory NK/T cell lymphoma and NK cell leukemia. Given the aggressive nature of these diseases and the limited treatment options available, this study aims to explore a novel therapeutic approach targeting the CD56 biomarker, which is highly expressed in these malignancies. Participants will receive the CAR T cell therapy and be monitored for treatment response and safety outcomes. The study is designed to provide insights into the potential of this innovative treatment in improving patient survival rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with relapsed or refractory NK/T cell lymphoma or NK cell leukemia who have no effective treatment options.

Not a fit: Patients who have not been diagnosed with NK/T cell lymphoma or NK cell leukemia, or those who are not within the specified age range, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with relapsed NK/T cell lymphoma and NK cell leukemia.

How similar studies have performed: While CAR T cell therapies have shown promise in other hematological malignancies, the specific application of Anti-CD56 CAR T therapy for NK/T cell lymphoma is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Patients or their legal guardians voluntarily participate and sign the informed consent;
2. Male or female patients aged 18-70 years (including 18 and 70 years);
3. 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.
4. The following two categories are included:(1)NK/T cell lymphoma;(2) NK cell leukemia.
5. 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.

6\. Measurable or evaluable lesions;

7\. The patient's main tissues and organs function well:

1. Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L;
2. Renal function: creatinine \< 220 μmol/L;
3. Lung function: indoor oxygen saturation ≥95%;
4. Cardiac function: left ventricular ejection fraction (LVEF) ≥40%.

8\. 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);

9\. The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous infusion;

10\. Patients with ECOG score ≤2 and expected survival time ≥3 months.

Exclusion Criteria:

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

Where this trial is running

Xuzhou, Jiangsu

• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)

Conditions Extranodal NK T Cell Lymphoma; NK-Cell Leukemia; Anti-CD56 CAR-T