Safety and Efficacy of DIT309 in Advanced Bone and Soft Tissue Sarcomas

ConditionsOsteosarcoma Soft Tissue Sarcoma

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

DIT309 cell injection
Biological/Vaccine
Patients receive CAR+ T cells via intravenous infusion on a single day, with pre-specified dose levels determined by the 3+3 dose escalation design detailed in the study protocol.

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Dose Escalation CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety：Incidence of Dose Limiting Toxicity (DLT)

Type, incidence, and severity of dose limiting toxicities (DLTs) within 28 days after the first DIT309 infusion.

Time frame

28 days after the first DIT309 infusion.

Safety：Incidence and severity of adverse events (AEs)

To evaluate the possible adverse events after DIT309 infusion, including the incidence, and severity of AEs.

Time frame

1year post CAR-T cells infusion.

The maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of DIT309.

Time frame

From first dose of DIT309 until the end of Dose Limiting Toxicity (DLT) observation period (typically 28 days post-infusion for each dose cohort).

Secondary outcomes

Progression Free Survival (PFS)

To evaluate the time from the start of DIT309 therapy to disease progression (according to RICIST1.1 criteria) or death from any cause, whichever occurs first. The proportion of progression-free subjects from the beginning of DIT309 therapy to a fixed time point (6 months) after treatment (6-Mon PFS) will also be evaluated.

Time frame

1 year post CAR-T cells infusion.

Disease Control Rate (DCR)

To evaluate the proportion of subjects who achieved CR/PR/SD in the best overall response according to RICIST1.1 criteria.

Time frame

1 year post CAR-T cells infusion.

Duration of disease control (DDC)

To evaluate the time from the first evaluation of tumor as CR, PR or SD to the first evaluation of PD or death from any cause.

Time frame

1 year post CAR-T cells infusion.

Objective response rate (ORR)

To evaluate the proportion of subjects who achieved CR/PR in the best response condition according to RICIST1.1 criteria.

Time frame

1 year post CAR-T cells infusion.

Other outcomes

The immunogenicity of DIT309

Drug antibody (ADA) positive rate after infusion of DIT309 cells.

Time frame

Up to 12 months

The positive rate of replication competent lentivirus tests

Detect replication competent lentivirus (RCL)

Time frame

Up to 15 years.

Peak Concentration (Cmax) of DIT309 CAR gene.

Time frame

Up to 12 months

Area under the concentration versus time curve (AUC) of DIT309 CAR-T cells

Up to 12 months.

Time frame

Area under the concentration versus time curve (AUC) of DIT309 CAR-T cells.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tcelltech Inc.

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

Source ClinicalTrials.gov

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