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Advanced Solid TumorPhase 1NCT06257680

A Phase I Study on ReT01 ACT for the Treatment of Advanced Solid Tumors

A Phase 1 study testing ReT01 ACT in people with Advanced Solid Tumor, run by Beijing Xunsheng Biomedical Research Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This single-armed, open, phase I study was designed to evaluate the safety and tolerance of ReT01 ACT injection in the treatment of advanced solid tumors. The phase I clinical trial is expected to be finished in 1 year. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
ReT01 ACT
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
8 Apr 2024to 18 Feb 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • They voluntarily signed the informed consent form (ICF) and completed the study procedure and follow-up examination and treatment.
  • Age from 18 to 75 years old, regardless of gender;
  • The ECOG performance status score was 0-1.
  • Advanced solid tumors positive for PAN-CK, confirmed histopathologically or cytologically: Advanced solid tumors that have failed previous standard therapy (disease progression or intolerance), currently have no standard treatment options, or are unable to receive current standard treatment for other reasons Included, but not limited to, driver gene negative non-small cell lung cancer (NSCLC) (except neuroendocrine tumors or mixed types containing >10% of neuroendocrine tumors), primary or metastatic breast cancer (TNBC), and histopathologically or cytologically confirmed patients with at least one prior platinum-based chemotherapy regimen and no more than three prior systemic treatment failures (disease progression or intolerance) Toxicity) of recurrent/metastatic cervical cancer (cervical squamous, adenosquamous, and adenocarcinoma subjects), ovarian cancer, liver cancer, head and neck cancer, and colorectal cancer (CRC);
  • Subjects had at least one eligible tumor lesion/tissue for preparation of ReT01 ACT injection. Fresh cancerous tissue (proximal metastatic lymph node or tumor margin tissue) with a total tumor volume of at least 0.125 cm3 was obtained by conventional surgical or interventional methods. The number of re-TILs in tumor tissue that met the needs of reinfusion and detection was sufficient.
  • The predicted survival time was ≥3 months.
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  • After tumor lesion/tissue sampling, the subject still had at least one measurable tumor lesion according to Response Evaluation criteria in Solid Tumors, version 1.1 (RECIST 1.1) criteria.
  • Patients with good organ function (no platelet or cell stimulating factor transfusion within 14 days before enrollment) and laboratory results meeting the following criteria: 1) absolute neutrophil count (ANC) ≥1.0×109/L; 2) platelet count (PLT) ≥80×109/L; 3) hemoglobin (Hb) ≥80 g/L; 4) Serum bilirubin (TBIL) ≤1.5× upper limit of normal (ULN), if the subject has Gilbert's syndrome or liver metastasis TBIL≤3×ULN; 5) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; If liver metastasis existed, ALT and AST≤5×ULN; 6) international normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN (except those on anticoagulant therapy); 7) creatinine clearance ≥60 mL/min (calculated by Cockcroft-Gault formula);
  • Toxic effects from previous therapy had resolved to grade 1 or less before enrollment (with the exception of grade 2 or less neurotoxicity from alopecia and chemotherapeutic agents).
  • Women of childbearing age who had a negative blood pregnancy test within 7 days before enrollment; Any male and female patient of childbearing potential must agree to use effective contraception for at least 6 months from enrollment until infusion of the ReT01 ACT injection. According to the investigator's judgment, a patient was considered to be fertile if the patient was biologically capable of having children and had a normal sexual life. Infertile women were required to meet at least one of the following criteria: 1) prior hysterectomy or bilateral oophorectomy, 2) medically confirmed ovarian failure, 3) medically confirmed, physiologic cessation of menstruation for at least 12 consecutive months (excluding use of chemoradiotherapy or estrogen/progestin-based drugs or other pathological factors);
  • The trial protocol was approved and adhered to, as judged by the investigators.

Who cannot join

  • There were only bone metastases.
  • Central nervous system metastases were present.
  • He had received other previous adoptive cell therapies.
  • Patients received any systemic anti-tumor therapy (including chemotherapy, radiotherapy, molecular targeted therapy, etc.) within 3 weeks before conditioning.
  • Chinese/herbal medicine with anti-tumor indications was received within 1 week before pretreatment.
  • Treatment with prednisone at a dose of 10 mg or more per day or its equivalent systemic corticosteroids (except for inhaled, topical, or physiological replacement therapy) or other immunosuppressive medications within 2 weeks before conditioning.
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  • Any major surgery within 4 weeks before screening that was considered by the investigator to be unsuitable for enrollment or any other planned major surgery during the study (excluding the planned surgery for the preparation of Re-TIL cells as specified in the protocol) (The definition of major surgery was based on the grade 3 and 4 procedures specified in the Administrative Measures for the Clinical Application of Medical Technology implemented on May 1, 2009). ;
  • Patients with other malignant tumors within 5 years before screening or at the same time (patients with locally treated malignant tumors that did not require treatment for more than 1 year and had no significant risk of recurrence according to the investigator's judgment were excluded, including but not limited to non-melanoma skin cancer, bladder cancer, etc.);
  • A history of active or suspected autoimmune or inflammatory disease;
  • Previous history of organ transplantation or hematopoietic stem cell transplantation;
  • Presence of any of the following infections: 1) active hepatitis B (hepatitis B surface antigen [HbsAg] positive and hepatitis B virus DNA [HBV-DNA] > 1000 copies /ml); 2) active hepatitis C (positive for hepatitis C virus (HCV) antibody and HCV RNA (HCV-RNA) test > the lower limit of study detection); 3) active systemic infections requiring antibiotics (e.g., sepsis, bacteremia, fungemia, etc.); 4) congenital or acquired immunodeficiency (including but not limited to severe combined immunodeficiency disease, human immunodeficiency virus (HIV) infection, etc.);
  • Vaccination with a live or attenuated vaccine within 4 weeks before conditioning;
  • Patients with severe cardio-cerebrovascular disease including but not limited to: 1) hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg) that is poorly controlled with medical therapy; 2) previous history of hypertensive crisis or hypertensive encephalopathy; 3) cardiovascular and cerebrovascular events, transient ischemic attack, myocardial infarction, unstable angina, and significant vascular disease (including but not limited to aortic aneurysm or proximal arterial thrombosis requiring surgical repair) within 6 months before enrollment; 4) New York Heart Association (NYHA) class ≥II heart failure with left ventricular ejection fraction (LVEF) <50%; Severe arrhythmias uncontrolled by medication (including QTc interval ≥450 ms in men or ≥470 ms in women, calculated according to Fridericia's formula), ongoing or planned use of medications that may prolong the QT interval, or congenital long QT syndrome;
  • Severe respiratory disease (previous or combined history of severe interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, or symptomatic bronchospasm); Forced expiratory volume in 1 second (FEV1) <2 L, carbon monoxide diffusion capacity (DLCO) (calibrated) <40%;
  • A clear previous history of a neurological or psychiatric disorder, including epilepsy or dementia;
  • A history of severe allergic reactions to drugs used during the study (including but not limited to cyclophosphamide, fludarabine, IL-2, components of ReT01 ACT injection, gentamicin, etc.);
  • Other conditions considered by the investigator to be inappropriate for participation in the trial (e.g., grade 3 or higher adverse effects from previous immunotherapy).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiujun Zhang contact

86-13910632260

azhang@aeonvital.com

China1 site, 1 recruiting

  • The Fifth Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality

    Sun Yingying

    Recruiting

Other trials in China

About this study

Official title: A Single-armed, Open, Phase I Study of ReT01 ACT Injection in the Treatment of Patients With Advanced Solid Tumors

This single-armed, open, phase I study was designed to evaluate the safety and tolerance of ReT01 ACT injection in the treatment of advanced solid tumors. The phase I clinical trial is expected to be finished in 1 year.

Being tested
ReT01 ACT

What participants receive

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

  • ReT01 ACTBiological

    Patients were infused with ReT01 ACT injection after pretreatment, and subjects were closely observed for 24 hours after each infusion.

Study groups in NCT06257680
Study groupRoleWhat they receive
ReT01 ACTExperimentalNot described
Receives: Biological: ReT01 ACT

What is being measured

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

  1. Maximal Tolerance Dose

    Measured: Up to Day 28

  2. Dose Limiting Toxicity

    Measured: Up to Day 28

  3. Adverse events (AE)

    Measured: through study completion, an average of 1 year

Secondary outcomes (7)

  1. Assess for Pharmacokinetics (PK)

    Evaluate the efficacy of ReT01 ACT based on PK which is analyzed by detection data.

    Measured: through study completion, an average of 1 year

  2. Assess for Pharmacodynamics (PD)

    Evaluate the efficacy of ReT01 ACT based on PD which is analyzed by detection data.

    Measured: through study completion, an average of 1 year

  3. Objective Response Rate (ORR)

    Evaluate the efficacy of ReT01 ACT based on ORR which is assess by RECIST v1.1.

    Measured: through study completion, an average of 1 year

  4. Progression Free Survival (PFS)

    Evaluate the efficacy of ReT01 ACT based on PFS which is assess by RECIST v1.1.

    Measured: through study completion, an average of 1 year

  5. Duration of Response (DOR)

    Evaluate the efficacy of ReT01 ACT based on DOR which is assess by RECIST v1.1.

    Measured: through study completion, an average of 1 year

  6. Disease Control Rate (DCR)

    Evaluate the efficacy of ReT01 ACT based on DCR which is assess by RECIST v1.1.

    Measured: through study completion, an average of 1 year

  7. Overall Survival (OS)

    Evaluate the efficacy of ReT01 ACT based on OS which is assess by RECIST v1.1.

    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 posted14 Feb 2024
  2. Study start8 Apr 2024
  3. Primary completion18 Feb 2025 (estimated)
  4. Study completion18 Feb 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06257680
Sponsor's protocol ID
ReT221101
Status last verified
Jul 2024
First submitted
25 Jan 2024
Last updated
31 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ReT01 ACT in people with Advanced Solid Tumor, run by Beijing Xunsheng Biomedical Research Co., Ltd. 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 11 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 31 Jul 2024. 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?

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?

Contact Xiujun Zhang (86-13910632260, azhang@aeonvital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Tolerance Dose (time frame: Up to Day 28). 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 NCT06257680.

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 31 Jul 2024.

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