Refractory/relapsed CD7 positive lymphoma
Conditions
Interventions
Sponsors
Beijing Boren Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-75 years (including the cut-off value), regardless of gender; 2. Subjects whose expected survival time is more than 60 days; 3. Subjects with ECoG score of 0-2; 4. Patients with malignant lymphoma diagnosed according to who 2016 criteria (including acute T-lymphoblastic leukemia, T-lymphoblastic lymphoma, NK / T-cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic lymphoma, enteropathy T-cell lymphoma, anaplastic large cell lymphoma, T-lymphoblastic leukemia); 5. At the time of screening, patients with CD7 Positive lymphoma were definitely diagnosed by pathological examination and met one of the following conditions: (1) No PR was obtained after standard at least 2-line treatment; (2) After standard treatment, the disease recurred or progressed; (3) Relapse after autologous or allogeneic hematopoietic stem cell transplantation; 6. At least one evaluable tumor (diameter >= 1.5cm) or tumor cells in bone marrow can be evaluated; 7. The patients with CD7 Positive in lymphoma (immunohistochemistry) and bone marrow (flow cytometry); 8. Patients who can understand the trial and sign informed consent voluntarily; 9. The patients who agreed to have no fertility requirement and plan within one year after participating in the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Patients with intracranial hypertension or cerebral disturbance of consciousness; 2. Evidence of tumor cells in peripheral blood: morphology, flow cytometry or molecular diagnosis; 3. Patients with symptomatic heart failure or severe arrhythmia; 4. Patients with symptoms of severe respiratory failure; 5. The patients with non completely cured malignant tumors (except carcinoma in situ) in the first 5 years were screened; 6. Subjects with disseminated intravascular coagulation; 7. Patients with sepsis or other uncontrollable infections; 8. Patients with severe mental disorder; 9. At the time of screening, there was evidence of CNS grade 3 invasion; 10. Patients who have received organ transplantation (excluding bone marrow transplantation); 11. Female patients (fertile patients) were positive for hCG; 12. HIV, syphilis screening positive patients; 13. Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive agents; 14. The patients with low absolute value of lymphocytes could not prepare cart cells; 15. Other researchers think that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation index ;Pharmacokinetic evaluation index ;Curative effect evaluation index ; | — |
Countries
China
Contacts
Public ContactKai Hu
Beijing Boren Hospital
Outcome results
None listed