CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHebei Senlang Biotechnology Inc., Ltd.
About this trial
To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL/ALL.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
relapse: Primordial cells (>5%)in peripheral blood or bone marrow appeared again after complete remission with standard treatment or Extramedullary disease appears，include：
Early recurrence within 12 months，
Late recurrence at 12 months or above and with no remission after a course of standard induction chemotherapy，
Recurrence after autologous or allogeneic hematopoietic stem cell transplantation ;
Disqualifiers
New York Heart Association (NYHA) classification ≥ grade III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris or other clinically prominent heart disease within one year before signing the informed consent form, Or QTc interval >480ms at screening (QTc interval calculated by Fridericia formula);
If the patient has a history of hematopoietic stem cell transplantation, 6 months after the patient received allogeneic hematopoietic stem cell transplantation;
Those with active GvHD or those who require immunosuppressive therapy;
Malignancy other than T-cell acute lymphoblastic leukemia/lymphoma within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer after radical surgery, radical surgery ductal carcinoma in situ;
Trial design
Design model
Single group
Treatments tested in this trial
CAR-T
Biological/VaccineCAR-T immunotherapy targeting CD7+
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: CD 7 CAR-TExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety: Incidence and severity of adverse events
Incidence and severity of adverse events
Time frame
28 days after infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov