In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChongqing Precision Biotech Co., Ltd
About this trial
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory malignant hematological tumors.
It is an early exploratory clinical study of the safety, tolerability and initial efficacy in the treatment of relapsed or refractory malignant hematological tumors.
Eligibility criteria
Qualifiers
Age ≥ 18 years old, gender unrestricted;
Confirmed diagnosis of relapsed/refractory malignant hematological tumors, including B-ALL, B-cell lymphoma and multiple myeloma;
ECOG performance status score 0-2, with an expected survival period of ≥ 3 months;
Absolute neutrophil count (ANC) ≥ 600/μL (no use of granulocyte colony-stimulating factor [G-CSF] within 1 week before screening, or no use of pegylated G-CSF within 2 weeks before screening); ③ Platelet count ≥ 50,000/μL; ④ Lymphocyte count ≥ 500/μL;
Disqualifiers
History of hematopoietic stem cell transplantation: Received allogeneic or autologous hematopoietic stem cell transplantation within 3 months before administration;
Received treatment related to vesicular stomatitis virus glycoprotein (VSVG) pseudotyped virus in the past;
Had severe and uncontrolled infections (bacterial, viral, fungal, etc.) within the screening period;
Had symptomatic heart failure or other serious cardiac diseases (such as severe arrhythmia);
Trial design
Treatments tested in this trial
- Invivo CAR-T
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov