Safety and Efficacy of DIT309 in Advanced Bone and Soft Tissue Sarcomas
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age8+
SponsorTcelltech Inc.
About this trial
This is a open-Label, dose-escalation study to evaluate the safety, tolerability and antitumor activity of DIT309 in subjects with advanced bone and soft tissue sarcomas.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.
Eligibility criteria
Qualifiers
Voluntarily agrees to participate in the clinical trial; is fully informed about the study and has signed the informed consent form (ICF); is willing and able to comply with all study procedures.
Male or female patients aged ≥8 weeks.
Histologically confirmed diagnosis of advanced bone and soft tissue sarcoma, who have failed or are intolerant to prior standard therapies.
At least one measurable lesion as defined by RECIST version 1.1.
Disqualifiers
Pregnant or breastfeeding women
Positive serology for HIV antibodies or syphilis
Positive HBsAg or HBcAb with HBV DNA above the lower limit of detection in peripheral blood
Positive HCV antibody with detectable HCV RNA in peripheral blood
Trial design
Treatments tested in this trial
- DIT309 cell injection
Treatment groups
15 Participants
are divided into 1 treatment groupLocations
1Shanghai General Hospital ShanghaiShanghai Municipality, China
Sponsors and collaborators
Tcelltech Inc.
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Source ClinicalTrials.gov