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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Invivo CAR-T
Biological/VaccinePatients were enrolled and given a single dose of CAR-T injection intravenously, hospitalized for observation over the following month, and followed up for observation over the following 2 years.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Invivo CAR-TExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximal Tolerated Dose(MTD)
MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.
Time frame
Up to 28 days after infusion2
Incidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Time frame
Up to 28 days after infusionSecondary outcomes
1
Objective Response Rate
Objective Response Rate(ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR).
Time frame
Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov