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New treatment option for Relapsed/Refractory T-cell Lymphoma
Official title CD70-CAR-NK Cell Therapy for T Cell Lymphoma and Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06696846
What this study is testing
What is CD70 CAR-NK?
CD70 CAR-NK is an investigational medicine, being studied as a potential treatment for relapsed/refractory t-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- CD70 is a promising target for immunotherapy because it is overexpressed in T-cell lymphoma (TCL) and acute myeloid leukemia (AML) tumor cells but is found in deficient levels in normal tissues and hematopoietic stem cells. This study aims to evaluate the safety and efficacy of CD70-targeted CAR-NK (CD70-CAR-NK) cells in patients with relapsed and refractory TCL and AML.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- According to the WHO disease classification, patients with relapsed/refractory T - lymphoma and acute myeloid leukemia:
- Voluntarily participate in this study and sign the informed consent form;
- Aged between 18-75 years old, both male and female are eligible;
- Relapsed/refractory T cell lymphoma is defined as: relapsed/refractory after having received at least two or more lines of previous treatment...
- The expected survival period ≥ 12 weeks;
You likely can't join if
- people meeting any of the following criteria will not be eligible for this study:
- Those with a history of allergy to any component in the cellular product;
- Those with a history of other tumors;
- Those who had grade II - IV (Glucksberg criteria) acute GvHD or extensive chronic GvHD after previous allogeneic hematopoietic stem cell...
- Those who have received gene therapy within the past 3 months;
- Those with active infections requiring treatment (except for simple urinary tract infections and bacterial pharyngitis). However, prophylactic...
See the full eligibility criteria
- According to the WHO disease classification, patients with relapsed/refractory T - lymphoma and acute myeloid leukemia:
- Voluntarily participate in this study and sign the informed consent form;
- Aged between 18-75 years old, both male and female are eligible;
- Relapsed/refractory T cell lymphoma is defined as: relapsed/refractory after having received at least two or more lines of previous treatment (patients with anaplastic large -cell lymphoma must have been exposed and...
- The expected survival period ≥ 12 weeks;
- CD70 expression is positive in tumor tissue puncture sections/tumor cells detected by flow cytometry, and the number of CD70 - positive cells detected by immunohistochemistry ≥ 20% (++ or more);
- ECOG score is 0 - 2;
- Adequate organ function reserve:
- Alanine aminotransferase and aspartate aminotransferase ≤ 2.5× UNL;
- Creatinine clearance rate (Cockcroft - Gault method) ≥ 60 mL/min;
- Serum total bilirubin and alkaline phosphatase ≤ 1.5× UNL;
- Glomerular filtration rate \> 50 ml/min;
- Cardiac ejection fraction ≥ 45%;
- Under indoor natural air environment, the basic oxygen saturation \> 92%;
- Routine blood test: absolute neutrophil count \> 1000/mm3, platelet count ≥ 45×109, hemoglobin ≥ 8.0g/dl (the standard for AML patients is ≥ 7.0g/dl; blood transfusion is allowed);
- Previous autologous hematopoietic stem cell transplantation is allowed once;
- Patients who have previously received CAR - T cell therapy and were evaluated as ineffective after 3 months or relapsed after CR are allowed;
- Female people of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial period;
- No active lung infection, and indoor air blood oxygen saturation ≥ 92%;
- Before the study drug is used, approved anti - tumor treatment methods, such as systemic chemotherapy, whole - body radiotherapy, and immunotherapy, have been completed for at least 3 weeks; the wash - out period for...
- Two negative tests for COVID - 19 or influenza A.
- people meeting any of the following criteria will not be eligible for this study:
- Those with a history of allergy to any component in the cellular product;
- Those with a history of other tumors;
- Those who had grade II - IV (Glucksberg criteria) acute GvHD or extensive chronic GvHD after previous allogeneic hematopoietic stem cell transplantation; or those who are currently receiving anti - GvHD treatment;
- Those who have received gene therapy within the past 3 months;
- Those with active infections requiring treatment (except for simple urinary tract infections and bacterial pharyngitis). However, prophylactic antibiotic, antiviral, and antifungal treatments are permitted;
- people with hepatitis B (HBsAg - positive, but HBV - DNA \< 103 is not an exclusion criterion) or hepatitis C virus infection (including virus carriers), syphilis, and other acquired or congenital immunodeficiency...
- people with grade III or IV cardiac insufficiency according to the New York Heart Association cardiac function classification standard of the United States;
- Those whose toxic reactions from previous anti - tumor treatment have not recovered (CTCAE 5.0 toxic reactions have not recovered to ≤ grade 1, except for fatigue, anorexia, and alopecia);
- people with a history of epilepsy or other central nervous system diseases;
- Lactating women who are unwilling to stop breastfeeding;
- Any other circumstances that, in the opinion of the investigator, may increase the risk to the subject or interfere with the test results;
- Those with positive nucleic acid tests for COVID - 19 or influenza A.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.