UnknownPhase 2

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

China20 participantsStarted 2023-05-01

Plain-language 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

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. 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%;

Exclusion criteria

. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall response rate (ORR)

Timeframe: From 1 month to 1 year.

progression-free survival (PFS)

Timeframe: From 1 month to 1 year.

overall survival (OS)

Timeframe: From 1 month to 1 year.

event-free survival (EFS)

Timeframe: From 1 month to 1 year.

Safety evaluation index

Timeframe: From 1 month to 1 year.

Trial details

NCT IDNCT05941156

SponsorThe Affiliated Hospital of Xuzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Extranodal NK T Cell Lymphoma trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. 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%;

Exclusion criteria

. 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;

What they're measuring

Overall response rate (ORR)

Timeframe: From 1 month to 1 year.

progression-free survival (PFS)

Timeframe: From 1 month to 1 year.

overall survival (OS)

Timeframe: From 1 month to 1 year.

event-free survival (EFS)

Timeframe: From 1 month to 1 year.

Safety evaluation index

Timeframe: From 1 month to 1 year.