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Soft Tissue SarcomaPhase 1NCT05621668

A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma

A Phase 1 study testing Cyclophosphamide and attIL2-T cells in people with Soft Tissue Sarcoma and Bone Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

To find a recommended dose of attIL2-T cell therapy that can be given to patients with soft tissue or bone sarcomas and to see if it can help to control the disease. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Soft Tissue Sarcoma, Bone Sarcoma
What is being tested?
Cyclophosphamide and attIL2-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
8 Sep 2023to 30 Sep 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Age .12 years old
  • Histologically-confirmed locally advanced or metastatic soft tissue or bone sarcoma
  • Osteosarcoma expansion cohort: histologically confirmed unresectable recurrent/metastatic osteosarcoma
  • Evaluable disease.
  • Patients must have received at least 1 prior line of systemic therapy for the treatment of sarcoma, unless no standard therapy exists for a specific sarcoma subtype
  • Prior Cancer Therapy . At least 3 weeks must have elapsed since the last cytotoxic chemotherapy or immunotherapy prior to leukapheresis/PBMC collection.
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  • For targeted therapies, at least 4 half-lives or 3 weeks must have elapsed prior to leukapheresis (whichever is shorter).
  • Standard of care anti-cancer therapy will be permitted following leukapheresis but prior to initiation of cyclophosphamide such that:
  • . At least 3 weeks must have elapsed since last cytotoxic chemotherapy or immunotherapy prior to starting treatment with cyclophosphamide.
  • . For targeted therapies, at least 4 half-lives or 3 weeks must have elapsed prior to initiation of treatment with cyclophosphamide (whichever is shorter).
  • . At least 2 weeks must have elapsed since last radiation therapy prior to cyclophosphamide.
  • . Investigational anti-cancer therapy will not be permitted.
  • ECOG performance status of 0 or 1 (Performance level as measured by Karnofsky for patients . 16 years of age or Lansky for patients < 16 years of age, see Appendix B)
  • Participants must be willing to undergo tumor biopsy
  • . Patients in whom biopsy is medically contraindicated or otherwise high risk will not be excluded and may forego research tumor biopsies
  • Patients must have organ and marrow function as defined below
  • Absolute neutrophil count (ANC) . 1 K/uL, Hemoglobin . 9 g/dL, Platelets.100 K/mm3
  • Serum creatinine . 2 mg/dL OR creatinine clearance > 50 mL/min
  • Aspartic transaminase (AST) . 1.5 x upper limit of normal (ULN), Alanine transaminase (ALT) . 1.5 x ULN, Bilirubin . 1.5 x ULN
  • Cardiac function . LVEF >50%
  • Pulmonary function
  • . Oxygen saturation >92% on room air
  • Total lung capacity >70% of predicted
  • DLCO >60% of predicted
  • Women of childbearing potential (WOCBP) must agree to use method(s) of contraception: at least one highly effective or two effective accepted methods of contraception to avoid conception throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal
  • Men must be willing and able to use an acceptable method of birth control such as latex condom during the dosing period and for at least 3 months after completion of the study agent administration (T cell infusion) if their sexual partners are WOCBP.
  • Signed Informed Consent and if applicable, pediatric assent

Who cannot join

  • Known sensitivity to cyclophosphamide and/or study agents Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years. Subjects with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
  • Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression. Subjects previously treated central nervous system metastases that are radiographically and neurologically stable for at least 6 weeks and do not require corticosteroids (of any dose) for symptomatic management for at least 14 days prior to first dose of attIL12-T cells are permitted to enroll. 3. Presence of metastatic disease in or near vital or critical structures that in the judgement of the treating physician in communication with PI or their delegate may lead to concern of immediate risk for harm from the inflammatory response.
  • 4. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment at the time of leukapheresis or attIL12 T cell infusion.
  • Standard of care anti-cancer therapy will be permitted following leukapheresis and prior to initiation of cyclophosphamide as bridging therapy (per section 12.4.1).
  • Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable.
  • In addition, local treatment (eg, by local surgery, radiotherapy, or ablation) of isolated lesions for palliative intent is acceptable beyond 30 days following attIL12 T cell administration with prior consultation and in agreement with the PI.
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  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5 Grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (eg, hearing loss) after consultation with the PI.
  • Investigational therapy for supportive care (e.g. COVID vaccine) will be permitted, as long as it is reviewed and discussed with the PI.
  • 5. History of primary immunodeficiency, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
  • 6. Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational products 7. Major surgery (as defined by the investigator) within 4 weeks prior to first dose of treatment or if still recovering from prior surgery. Biopsy as per study protocol is allowed 8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from the study agents, or compromise the ability of the subject to give written informed consent.
  • 9. Subjects with cognitive impairment, including adults with cognitive impairment such as trisomy 21 or similar conditions are not specifically excluded from participation, such that appropriate written informed consent is obtained from the parent or legal guardian and they are able to complete with the study protocol requirements and treatment.
  • 10. Active concurrent second malignancy 11. Pregnant or lactating women 12. Any positive test result for hepatitis B or C virus indicating acute or chronic infection 13. Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

To find a recommended dose of attIL2-T cell therapy that can be given to patients with soft tissue or bone sarcomas and to see if it can help to control the disease.

Read the detailed description

Primary Objective:

  1. Part A. Determine the safety, maximum tolerated dose and/or recommended phase 2 dose of adoptively transferred T cell membrane-anchored tumor targeted IL12 (attIL12)-T cells in combination with cyclophosphamide in patients with advanced/metastatic soft tissue or bone sarcomas
  2. Part B. Characterize the safety and tolerability and assess preliminary efficacy of attIL12-armed T cells in combination with cyclophosphamide by evaluating the 4-month disease control rate (DCR4 months) in patients with recurrent unresectable osteosarcoma

Secondary Objectives:

  1. Evaluate the anti-tumor efficacy achieved following adoptive transfer of T cellmembrane-anchored tumor targeted IL12 (attIL12)-T cells in combination with cyclophosphamide in patients with advanced/metastatic soft tissue or bone sarcomas

Exploratory Objectives:

  1. Characterize the immune response following adoptive transfer of T cell membrane-anchored tumor targeted IL12 (attIL12)-T cells in paired in pre-treatment and on-treatment tumor specimens and peripheral blood samples
  2. Assess FoxP3/CD33/CD8/IFNg expression in pre-treatment and on-treatment tumor specimens and correlate with clinical benefit/anti-tumor response
  3. Determine changes in cell surface vimentin (CSV)-positive circulating tumor cells (CTCs) in peripheral blood before and after adoptive transfer of T cell membrane-anchored tumor targeted IL12 (attIL12)-T cells and correlate with clinical benefit/anti-tumor response
Being tested
Cyclophosphamide, attIL2-T cells
Medical subject headings
Sarcoma, Bone Neoplasms

What participants receive

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

  • CyclophosphamideDrug

    Also called Cytoxan®, Neosar®

    Given by IV (vein)

  • attIL2-T cellsDrug

    Given by IV (vein)

Study groups in NCT05621668
Study groupRoleWhat they receive
Part A: Dose Findings (MTD)ExperimentalThe dose of attIL2-T cell therapy the participants will receive will depend on when the participants joined this study. The first group of participants will receive the lowest dose level of attIL2-T cell therapy.
Receives: Drug: Cyclophosphamide; Drug: attIL2-T cells
Part B: Osteosarcoma Dose ExpansionExperimentalParticipants will receive attIL2-T cell therapy at the recommended dose that was found in Phase 1.
Receives: Drug: Cyclophosphamide; Drug: attIL2-T cells

What is being measured

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

  1. To examine the incidence of adverse events.

    National Cancer Institute, Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. from screening through the treatment period

    Measured: through study completion; an average of 1 year.

Timeline

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

  1. First posted18 Nov 2022
  2. Study start8 Sep 2023
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05621668
Sponsor's protocol ID
2021-0619
Other IDs
NCI-2022-09675
Status last verified
Aug 2026
First submitted
10 Nov 2022
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cyclophosphamide and attIL2-T cells in people with Soft Tissue Sarcoma and Bone Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.

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 27 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 18 Aug 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

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?

To examine the incidence of adverse events. (time frame: through study completion; an average of 1 year.). 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 NCT05621668.

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 18 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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