CD7 CAR-T Cell Therapy Targeting CD7-positive Relapsed/Refractory T Cell Lymphoma/Acute Leukemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-75
SponsorQi deng
About this trial
CD7 molecules are thought to be associated with disease aggressiveness, drug resistance, and poor prognosis. Intensive chemotherapy, immunotherapy, hematopoietic stem cell transplantation (HSCT) and other treatment regimens have achieved remarkable results in the treatment of hematologic malignant diseases. Nevertheless, patients with hematologic malignancies may still tolerate acquired therapy during the above treatments, and molecular targeted immunotherapy provides a safe, efficient and specific treatment for such patients The scheme has attracted more and more researchers' attention. The use of CD7 molecules as a new target for molecularly targeted anti-tumor therapy may provide a new research direction for the treatment of CD7 relapsed/refractory hematologic malignancies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Relapsed/refractory T-cell malignant lymphoma: patients who have not remission and recurrence after at least 2 courses of standardized second-line or above treatment (including hematopoietic stem cell transplantation).
Bone marrow flow cytometry detected tumor cells as CD7 and/or extramedullary lesions with a clear diagnosis of CD7 by pathological immunohistochemistry at the time of enrollment screening;
If tumor cells are detected in peripheral blood during enrollment screening, flow cytometry must be used to detect that the immunophenotype of tumor cells on the surface of tumor cells is both negative for CD4 and CD8. If the immunophenotype on the surface of peripheral blood tumor cells is not CD4 and CD8 negative, the proportion of peripheral blood tumor cells must be ≤1%;
Expected survival greater than 3 months from the date of signing the informed consent form;
Disqualifiers
One of the following cardiac criteria occurs: atrial fibrillation; Myocardial infarction within the past 12 months; Prolonged QT syndrome or secondary QT Extension, to be determined by the researcher. Echocardiography with LVSF<30% or LVEF<50%; Clinically significant pericardial effusion; Heart function Incomplete NYHA III or IV (confirmed by echocardiography within 12 months after treatment);
Active GVHD;
Have a history of severe pulmonary dysfunction;
Merge other advanced malignant tumors;
Trial design
Design model
Single group
Treatments tested in this trial
CD7 CART
Biological/VaccineFor intravenous infusion
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: CD7 CAR-TExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the safety of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
the incidence and severity of immune therapy related toxic reactions (irAEs)
Time frame
up to one month after the CAR-T infusion2
Evaluate the effcacy of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
CR rate on M1 and M3
Time frame
one month and three month after the CAR-T infusion3
Evaluate the effcacy of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia
ORR(CR and PR) on M1 and M3
Time frame
one month and three month after the CAR-T infusionSecondary outcomes
1
long-term efficacy
DOR
Time frame
up to one year after the CAR-T infusion2
long-term efficacy
PFS
Time frame
up to one year after the CAR-T infusion3
long-term efficacy
OS
Time frame
up to one year after the CAR-T infusion4
Cell pharmacokinetics Dynamic indicators
CAR-T/T% by flow cytometry
Time frame
Day7, Day10, Day14, Day28 after the CAR-T infusionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Qi deng
Lead sponsor
Tianjin First Central Hospital
Sponsor institution
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: