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OsteosarcomaPhase 1NCT07052383

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

A Phase 1 study testing DIT309 cell injection in people with Osteosarcoma and Soft Tissue Sarcoma, run by Tcelltech Inc. at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 8 years and older
Conditions the study is for
Osteosarcoma, Soft Tissue Sarcoma
What is being tested?
DIT309 cell injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
6 Nov 2025to 10 Oct 2027
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • Tumor tissue demonstrates positive expression for the target antigen according to the protocol-defined criteria.
  • ECOG performance status of 0-1 within 24 hours prior to leukapheresis and prior to lymphodepletion.
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  • Life expectancy of more than 6 months.
  • Adequate venous access for leukapheresis, with no contraindications for the procedure.
  • Laboratory parameters must meet the following criteria:
  • Hematologic function: WBC ≥ 3.0 × 10⁹/L; Hemoglobin ≥ 8.0 g/dL; ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 75.0 × 10⁹/L
  • Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
  • Hepatic function: ALT and AST ≤ 2.5 × ULN (≤ 5.0 × ULN for subjects with liver metastasis)
  • Total bilirubin ≤ 2.0 × ULN (excluding patients with Gilbert's syndrome, defined as persistent or recurrent unconjugated hyperbilirubinemia without evidence of hemolysis or hepatic pathology)
  • Coagulation: Without anticoagulation therapy, PT, APTT, or INR ≤ 1.5 × ULN
  • Negative pregnancy test for female subjects of childbearing potential
  • Subjects of childbearing potential must agree to use effective contraception from the date of signing the informed consent through 6 months after the last infusion.

Who cannot join

  • Pregnant or breastfeeding women
  • Viral infections:
  • 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
  • Medical history and comorbidities:
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  • Known hypersensitivity to DIT309 cells or any component of the investigational products (including fludarabine, cyclophosphamide, or trastuzumab), or history of severe allergic reactions
  • Known active autoimmune diseases (e.g., Crohn's disease, systemic lupus erythematosus); subjects with vitiligo or childhood asthma in complete remission and not requiring treatment in adulthood may be eligible; subjects requiring medical intervention such as bronchodilators for asthma are not eligible
  • Currently receiving systemic immunosuppressive therapy or anticipated need for long-term immunosuppression during the study (topical, inhaled, or intranasal corticosteroids used intermittently are allowed)
  • Prior exposure to any gene-modified T cell therapy (e.g., CAR-T or TCR-T) or any form of gene therapy*
  • History of uncontrolled neurological or psychiatric disorders that may increase the risk of participation or interfere with study results in the investigator's opinion, including but not limited to epilepsy, dementia, or major depression
  • Untreated or symptomatic CNS or leptomeningeal metastases
  • Unresolved toxicities from prior treatment that have not recovered to Grade ≤1 per CTCAE v5.0 (except for toxicities deemed not to pose safety risk by the investigator, such as alopecia, Grade 2 peripheral neuropathy, or hypothyroidism managed with replacement therapy)
  • History of other primary solid malignancies
  • Major surgery or significant trauma within 1 month prior to leukapheresis
  • Any serious or uncontrolled comorbidity that, in the investigator's opinion, may increase risks associated with study participation or investigational drug administration, including but not limited to: cardiovascular or cerebrovascular disease, renal insufficiency, pulmonary embolism, coagulation disorders requiring long-term anticoagulation, active or uncontrolled infections requiring systemic treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Efficacy of DIT309 Cell Injection in Subjects With Advanced Bone and Soft Tissue Sarcomas

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.

Read the detailed description

Subjects will be enrolled to receive DIT309 via intravenous infusion. Patients will be administered DIT309 on Day 1 of each 28-day treatment cycle, followed by a 28-day observation period.

The study will include three escalating dose levels, utilizing a traditional 3+3 dose escalation design. Each dose level will enroll 3 to 6 patients. Dose-limiting toxicities (DLTs) will be assessed during the first treatment cycle to evaluate the safety and tolerability of DIT309.

Being tested
DIT309 cell injection
Keywords
Advanced
Medical subject headings
Osteosarcoma, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DIT309 cell injectionBiological

    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.

Study groups in NCT07052383
Study groupRoleWhat they receive
Dose Escalation CohortExperimentalDIT309 were administered via intravenous reinfusion on Days 1 in a 28-day treatment cycle.
Receives: Biological: DIT309 cell injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety：Incidence of Dose Limiting Toxicity (DLT)

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

    Measured: 28 days after the first DIT309 infusion.

  2. Safety：Incidence and severity of adverse events (AEs)

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

    Measured: 1year post CAR-T cells infusion.

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

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

    Measured: 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 (6)

  1. 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.

    Measured: 1 year post CAR-T cells infusion.

  2. 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.

    Measured: 1 year post CAR-T cells infusion.

  3. 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.

    Measured: 1 year post CAR-T cells infusion.

  4. Objective response rate (ORR)

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

    Measured: 1 year post CAR-T cells infusion.

  5. Time to Remission (TTR)

    To evaluate the time from the start of treatment to the first remission (CR/PR).

    Measured: 1 year post CAR-T cells infusion.

  6. Duration of Response (DOR)

    DOR after DIT309 infusion, defined as the time from the first evaluation of the tumor as CR or PR to the first evaluation of PD or death from any cause.

    Measured: 1 year post CAR-T cells infusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2025
  2. Study start6 Nov 2025
  3. Primary completion10 Oct 2027 (estimated)
  4. Study completion10 Oct 2027 (estimated)

Why it stopped: Data update in progress.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07052383
Sponsor's protocol ID
DIT309T-IS001
Status last verified
Oct 2026
First submitted
26 Jun 2025
Last updated
14 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DIT309 cell injection in people with Osteosarcoma and Soft Tissue Sarcoma, run by Tcelltech Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety：Incidence of Dose Limiting Toxicity (DLT) (time frame: 28 days after the first DIT309 infusion.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07052383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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