AzTrials
AzTrials

Solid TumorEarly Phase 1NCT05971589

A Clinical Study on LM103 Injection for the Treatment of Advanced Solid Tumors

A Early Phase 1 study testing LM103 in people with Solid Tumor, run by Suzhou BlueHorse Therapeutics Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in advanced solid tumor patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor
What is being tested?
LM103
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
No sites listed yet
Study dates
Aug 2023to Aug 2026
Phase
Early 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The expected survival time is not less than 6 months.
  • Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.
  • Patients with advanced solid tumors confirmed by histology or cytology: advanced Melanoma, head and neck squamous cell cancer, soft tissue sarcoma and other solid tumors that have failed standard treatment regimens, cannot tolerate standard treatment, refuse or do not have standard treatment regimens available.
  • The patient has lesions that can be used for surgical resection (>1.5 cm^3) or biopsy puncture (no less than 6 lesions) for TILs collection.
  • At least one measurable lesion as the target lesion after collecting tumor tissue from the patient (RECIST v1.1 criteria).
  • Laboratory tests results during the screening period indicate that the subjects have sufficient organ function.

Who cannot join

  • Have a medical history of other malignant tumors other than the disease under study in the past 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to thyroid cancer, cervical Carcinoma in situ, basal or squamous cell skin cancer or Ductal carcinoma in situ of the breast treated by radical surgery).
  • LM103 received systematic Sex therapy of antineoplastic drugs (including chemotherapy, small molecule targeted drug therapy, Hormone replacement therapy, etc.), or local antineoplastic therapy (such as radiotherapy, palliative radiotherapy for bone metastases>2 weeks before the start of the study and intracranial stereotactic radiotherapy or resection of a single brain metastasis>3 weeks before the start of the study were acceptable) within 4 weeks before LM103 infusion; Or received clinical investigational drugs or equipment treatment.
  • Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) level 1 or below (excluding hair loss and neurotoxicity, which have been determined by the researchers to be irreparable and level 2 hypothyroidism for a long time).
  • Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.

Trial locations and contacts

No sites are listed yet.

Jilong yang contact

+86 22-23340123 ext. 1081

yangjilong@tjmuch.com

About this study

Official title: An Exploratory Clinical Study Evaluating the Safety, Tolerance, Immune Response, and Initial Efficacy of Autologous Tumor Infiltrating Lymphocytes (TILs) LM103 Injection in Patients With Advanced Solid Tumors

This study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in advanced solid tumor patients. The research treatment includes fludarabine and cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and Interleukin-2 therapy.

Conditions
Solid Tumor
Being tested
LM103

What participants receive

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

  • LM103Biological

    Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation and extensive expansion.

Study groups in NCT05971589
Study groupRoleWhat they receive
Intravenous of LM103Experimental≥5×10^9 cells (LM103) will be infused i.v. to patients after non-myeloablative lymphodepletion treatment with Cyclophosphamide for Injection and Fludarabine Phosphate for Injection.
Receives: Biological: LM103

What is being measured

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

  1. Adverse events (AE), Serious adverse event (SAE) and immune related adverse events (irAE)

    Incidence and severity of AE, SAE and irAE; Abnormal changes in laboratory and other tests with clinical significance.

    Measured: through study completion, an average of 1 year estimate

Secondary outcomes (8)

  1. Objective response rate (ORR)

    The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1.

    Measured: through study completion, an average of 1 year estimate

  2. Duration of response (DOR)

    Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause.

    Measured: through study completion, an average of 1 year estimate

  3. Disease control rate (DCR)

    Disease control rate (DCR) was defined as the percentage of participants with a best overall response of complete response, partial response or stable disease as defined by RECIST version 1.1.

    Measured: through study completion, an average of 1 year estimate

  4. Time to response (TTR)

    Time to response (TTR) is defined as the time from randomization until the first documented evidence of CR or PR.

    Measured: through study completion, an average of 1 year estimate

  5. Time to disease progression (TTP)

    Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to the solid tumor.

    Measured: through study completion, an average of 1 year estimate

  6. Progression free survival (PFS)

    Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST version 1.1) or death due to any cause.

    Measured: through study completion, an average of 1 year estimate

  7. Overall survival (OS)

    OS was defined as the time from first dose to date of death from any cause.

    Measured: through study completion, an average of 1 year estimate

  8. Peripheral blood TILs cell survival

    Detection using flow cytometry

    Measured: through study completion, an average of 1 year estimate

Timeline

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

  1. First posted2 Aug 2023
  2. Study startAug 2023 (estimated)
  3. Primary completionApr 2026 (estimated)
  4. Study completionAug 2026 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05971589
Sponsor's protocol ID
LM103-003
Status last verified
Jul 2023
First submitted
12 Jul 2023
Last updated
2 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li F, Xu Y, Wang Y, Mu N, Liu M, Feng W, Xue Y, Wu S, Wang X, Lizee G, Ma C. Multiple autologous tumor-infiltrating lymphocyte (LM103 infusion) therapy combined with immune checkpoint inhibitor induces repeated tumor regression in a patient with aggressive mucosal melanoma: a case report and literature review. Front Oncol. 2026 Apr 23;16:1789442. doi: 10.3389/fonc.2026.1789442. eCollection 2026.

    PubMed 42109657

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing LM103 in people with Solid Tumor, run by Suzhou BlueHorse Therapeutics Co., Ltd..

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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Contact Jilong yang (+86 22-23340123 ext. 1081, yangjilong@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AE), Serious adverse event (SAE) and immune related adverse events (irAE) (time frame: through study completion, an average of 1 year estimate). 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 NCT05971589, which also lists 1 linked publication.

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 2 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in