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Clinical Trial NCT05941156 for Extranodal NK T Cell Lymphoma, NK-Cell Leukemia is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Clinical Study of Anti-CD56-CAR-T in the Treatment of Relapsed/Refractory NK/T Cell Lymphoma /NK Cell Leukemia Phase 2 20

Recruiting
Clinical Trial NCT05941156 is designed to study Treatment for Extranodal NK T Cell Lymphoma, NK-Cell Leukemia. It is a Phase 2 interventional study that is recruiting, having started on May 1, 2023, with plans to enroll 20 participants. Led by The Affiliated Hospital of Xuzhou Medical University, it is expected to complete by May 1, 2026. The latest data from ClinicalTrials.gov was last updated on July 12, 2023.
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
Detailed Description
Extranodal NK/TCL is an aggressive disease with a poor prognosis and a 5-year survival rate of less than 50%. In the absence of effective treatment, median survival for advanced disease is only 6-12 months. A retrospective review of the International Peripheral T-Cell Lymphoma Project recently reported that the median overall survival of NK/TCL was 7.8 months, corresponding to the worst survival of all T-cell lymphom...Show More
Official Title

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

Conditions
Extranodal NK T Cell LymphomaNK-Cell Leukemia
Other Study IDs
  • XYFY2023-KL123-01
NCT ID Number
NCT05941156
Start Date (Actual)
2023-05-01
Last Update Posted
2023-07-12
Completion Date (Estimated)
2026-05
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Anti-CD56 CAR-T
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCAR-T Cell Infusion
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...Show More
Anti-CD56 CAR T
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 in...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
CAR T cell index of correlation
The presence of peripheral blood and bone marrow CAR-T cells were measured regularly by using flow cytometry, quantitative PCR techniques.
From 1 month to 1 year.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
The Affiliated Hospital of Xuzhou Medical University logoThe Affiliated Hospital of Xuzhou Medical University
No contact data.
1 Study Locations in 1 Countries

Jiangsu

The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221002, China
Wei Sang, M.D., Ph.D, Contact, 13645207648, [email protected]
Recruiting