CD7 CAR-T Cells in T-cell Lymphoma/Leukemia

Last updated: November 11, 2022
Sponsor: Shenzhen University General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Leukemia

Treatment

N/A

Clinical Study ID

NCT05620680
HEM-ONCO-017
  • Ages 18-75
  • All Genders

Study Summary

T-cell lymphoma/leukemia is a group of highly lethal diseases with a high relapse rate and poor prognosis. CD7 was proved to be widely expressed in T-cell malignant, which makes it a promising therapeutic target.

In this study we aim to test the safety and efficacy of CD7 CAR-T cells in T-cell lymphoma/leukemia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited;
  2. The subject voluntarily participates in the research and signs the "Informed Consent"by himself or his legal guardian;
  3. According to the National Comprehensive Cancer Network (NCCN) T lymphocytic lymphoma (2020.V1)/acute lymphoblastic leukemia (2020. V1) practice guidelines, diagnosed withT-cell lymphoma;
  4. Meet the diagnostic criteria for relapsed/refractory T-cell lymphoma, including any ofthe following:
  1. Failure to obtain CR at the end of induction therapy; 2) Patients who have obtained CRhave blasts in peripheral blood or bone marrow (proportion >5%), or extramedullarydiseases; 5. Have not received antibody therapy within 2 weeks before cell therapy; 6. ECOGscore of 0-2; 7. The subject has no contraindications to peripheral apheresis; 8. Expectedsurvival time of more than 3 months.

Exclusion

Exclusion Criteria:

  1. Those who have a history of allergy to any of the ingredients in cell products;
  2. Laboratory tests for the following: including but not limited to, total serumbilirubin≧ 1.5mg/dl; Serum ALT or AST greater than 2.5 times the upper limit ofnormal; Blood creatinine≧ 2.0mg/dl; Platelet count≦ 10×109/L;
  3. Patients with cardiac insufficiency who belong to class III or IV according to the NewYork Cardiology Association (NYHA) cardiac function grading standards; orechocardiography with left ventricular ejection fraction (LVEF) < 50%;
  4. Abnormal lung function, blood oxygen saturation under indoor air < 92%;
  5. Myocardial infarction, cardiac angioplasty or stenting, unstable angina, or otherserious clinical heart disease within 12 months before enrollment;
  6. Grade 3 hypertension with poor control of blood pressure with medication;
  7. Patients with other advanced tumors (those who are assessed as stable after treatmentof other tumors can be enrolled);
  8. Previous head trauma, impaired consciousness, epilepsy, more serious cerebral ischemiaor cerebral hemorrhage disease;
  9. Known central nervous system leukemia (CNS2 or CNS3), resistance to intrathecalchemotherapy injections and/or ongoing head and/or spinal radiation therapy; PreviousCNS history but has been effectively controlled to allow enrollment;
  10. Patients with autoimmune diseases, immunodeficiency or other patients requiringimmunosuppressant therapy;
  11. presence of uncontrolled, active infection;
  12. Have previously used any CAR-T cell product or other genetically modified T celltherapy;
  13. Live vaccination within 4 weeks prior to enrollment;
  14. HIV, HBV, HCV and TPPA/RPR infections, and HBV carriers;
  15. Subject has a history of alcoholism, drug addiction or mental illness;
  16. The subject has participated in any other clinical research within 3 months beforejoining this clinical study;
  17. Female subjects have any of the following conditions: a) are pregnant/lactating; or b)have plans to become pregnant during the trial; or c) are of childbearing potentialand unable to use effective contraception;
  18. There are other circumstances in which the investigator believes that the subject isnot suitable for this study.

Study Design

Total Participants: 20
Study Start date:
October 01, 2022
Estimated Completion Date:
October 31, 2028

Study Description

T-cell lymphoma accounts for 10%~15% of non-Hodgkin lymphoma in China. According to the World Health Organization (WHO), T-cell lymphoma was divided into the following subtypes: T-cell, NK cell lymphoma/leukemia. There were two major categories: anterior T-cell tumors and posterior thymic T-cell lymphomas, which originate from lymph nodes, extranodal tissue, or skin; mature or peripheral T-cell lymphomas.

Generally speaking, the relapse accounts for 50-60% after first-line treatment, while the remission rate with second-line treatment was extremely low. Collectively, there was an urgent need for new treatment modalities to improve the clinical outcomes of these patients.

CD7 is a transmembrane glycoprotein that plays an important role in T-cell and T-cell/B-cell interactions during early lymphoid development. The expression of CD7 persist from stem to mature T cells. CD7 was proved to be widely expressed in T-cell malignant, which makes it a promising therapeutic target.

In this study we aim to testify the safy and efficacy of CD7 CAR-T cells in T-cell lymphoma/leukemia.

Connect with a study center

  • Li Yu

    Shenzhen, Guangdong 518000
    China

    Active - Recruiting

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