Solid TumorsEarly Phase 1NCT05648994
TCR-T Cells for the Treatment NY-ESO-1-positive Advanced Solid Tumors
A Early Phase 1 study testing TCR-T cells, Fludarabine and Cyclophosphamide Capsules in people with Solid Tumors, run by Fujian Cancer Hospital.
Trial summary
New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a Cancer-Testis Antigen (CTA) which is expressed in various tumors. After selected the high affinity TCR gene to NY-ESO-1, the researchers insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- TCR-T cells, Fludarabine and Cyclophosphamide Capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Mar 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have the willingness to communicate with investigator, be able to understand and follow the trail requirements, and voluntarily to participate in the trail;
- 18 ~70 years old (gender is not limited;)
- The expected survival period is at least 3 months;
- ECOG score of 0-1;
- Patients with recurrent or metastatic solid tumors confirmed by histopathology;
- Subjects who failed standard treatment in the past or have no standard treatment currently tor who are judged by the investigator to be unsuitable for current standard treatment for other reasons, and the objective imaging assessment is disease progression;
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- According to RECIST 1.1 standard, there is at least one measurable target lesion for efficacy evaluation;
- NY-ESO-1 positive;
- HLA type is HLA-A2 (except HLA-A*0203);
Who cannot join
- Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test at baseline;
- Subjects who have had severe allergic reactions to any drug or its components in this trial in the past;
- Subjects who have received any investigational drug within 28 days before the infusion of TIL cells, or participated in another clinical study at the same time;
- Subjects who have other known history of malignant tumors in the past 5 years, except for localized tumors that have been cured, including in situ cervical carcinoma, basal cell carcinoma of the skin, and in situ prostate carcinoma;
- Patients who have received adoptive cell therapy in the past;
- According to the judgment of the investigator, the condition of the subject is not suitable for this trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-arm, Open-label, Dose-finding Clinical Study of TCR-T Cells in Patients With HLA-A2-expressing and NY-ESO-1-positive Recurrent or Metastatic Solid Tumors
New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a Cancer-Testis Antigen (CTA) which is expressed in various tumors. After selected the high affinity TCR gene to NY-ESO-1, the researchers insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. Then the engineered cells are re-infused in the patients with tumors for curing the tumor patient or prolonging life.
Read the detailed description
This is a single-center, open-label, Phase I clinical study of TCR-T cells for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.
TCR-T cells are expanded from peripheral blood, and after ex vivo modification, and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.
The primary purpose of this study is to evaluate the safety and tolerability of TCR-T cells in patients with recurrent/metastatic solid tumors.
The second purpose of this study is to preliminarily explore the effectiveness of TCR-T cells in patients with recurrent/metastatic solid tumors.
Eligibility:
Adults aging 18-70 who were failed to standard treatment or have no standard treatment with recurrent/metastatic solid tumors.
- Conditions
- Solid Tumors
- Being tested
- TCR-T cells, Fludarabine, Cyclophosphamide Capsules, Albumin-bound paclitaxel, IL-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCR-T cellsBiological
patients will be administration of TCR-T cells
FludarabineDrug
Part of the non-myeloablative lymphocyte-depleting preparative regime
Cyclophosphamide CapsulesDrug
Part of the non-myeloablative lymphocyte-depleting preparative regime
Albumin-bound paclitaxelDrug
Part of the non-myeloablative lymphocyte-depleting preparative regime
IL-2Drug
Following cell infusion, the patient will be administration high-dose IL-2.
| Study group | Role | What they receive |
|---|---|---|
| TCR-T cells | Experimental | TCR-T cells will be infused to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen. Receives: Biological: TCR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide Capsules; Drug: Albumin-bound paclitaxel; Drug: IL-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality recognized by Investigators, and should be possibly related to TCR-T cells therapy
Measured: up to Day28
Adverse Event
The severity and incidence of various adverse events and serious adverse events
Measured: up to 24 months
Secondary outcomes (3)
Overall response rate (ORR)
Objective response rate (ORR) is defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors [RECIST 1.1]) is observed as best overall response
Measured: up to 24 months
Progression free survival (PFS)
PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first
Measured: up to 24 months
Overall survival
OS defined as the time from start of treatment to the date of death due to any cause
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study startDec 2022 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zhiyong He, Principal investigator, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648994
- Sponsor's protocol ID
- FJ002
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Dose-finding Clinical Study of TCR-T Cells in Patients With HLA-A2-expressing and NY-ESO-1-positive Recurrent or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05648994
- Acronym / sponsor ID
- FJ002
- Conditions
- Solid Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- Dec 2022 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a Cancer-Testis Antigen (CTA) which is expressed in various tumors. After selected the high affinity TCR gene to NY-ESO-1, the researchers insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. Then the engineered cells are re-infused in the patients with tumors for curing the tumor patient or prolonging life.
Detailed description
This is a single-center, open-label, Phase I clinical study of TCR-T cells for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.
TCR-T cells are expanded from peripheral blood, and after ex vivo modification, and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.
The primary purpose of this study is to evaluate the safety and tolerability of TCR-T cells in patients with recurrent/metastatic solid tumors.
The second purpose of this study is to preliminarily explore the effectiveness of TCR-T cells in patients with recurrent/metastatic solid tumors.
Eligibility:
Adults aging 18-70 who were failed to standard treatment or have no standard treatment with recurrent/metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TCR-T cells | Experimental | Biological: TCR-T cells, Drug: Fludarabine, Drug: Cyclophosphamide Capsules, Drug: Albumin-bound paclitaxel, Drug: IL-2TCR-T cells will be infused to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have the willingness to communicate with investigator, be able to understand and follow the trail requirements, and voluntarily to participate in the trail;
- 18 ~70 years old (gender is not limited;)
- The expected survival period is at least 3 months;
- ECOG score of 0-1;
- Patients with recurrent or metastatic solid tumors confirmed by histopathology;
Key exclusion criteria (6 listed)
- Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test at baseline;
- Subjects who have had severe allergic reactions to any drug or its components in this trial in the past;
- Subjects who have received any investigational drug within 28 days before the infusion of TIL cells, or participated in another clinical study at the same time;
- Subjects who have other known history of malignant tumors in the past 5 years, except for localized tumors that have been cured, including in situ cervical carcinoma, basal cell carcinoma of the skin, and in situ prostate carcinoma;
- Patients who have received adoptive cell therapy in the past;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCR-T cellspatients will be administration of TCR-T cells | Biological | TCR-T cells |
| FludarabinePart of the non-myeloablative lymphocyte-depleting preparative regime | Drug | TCR-T cells |
| Cyclophosphamide CapsulesPart of the non-myeloablative lymphocyte-depleting preparative regime | Drug | TCR-T cells |
| Albumin-bound paclitaxelPart of the non-myeloablative lymphocyte-depleting preparative regime | Drug | TCR-T cells |
| IL-2Following cell infusion, the patient will be administration high-dose IL-2. | Drug | TCR-T cells |
Primary outcome
Dose Limiting Toxicity
Time frame: up to Day28
Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality recognized by Investigators, and should be possibly related to TCR-T cells therapy
Adverse Event
Time frame: up to 24 months
The severity and incidence of various adverse events and serious adverse events
3 secondary outcomes
Overall response rate (ORR)
Time frame: up to 24 months
Progression free survival (PFS)
Time frame: up to 24 months
Overall survival
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: No
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiyong He principal investigator
Fujian Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TCR-T cells, Fludarabine and Cyclophosphamide Capsules in people with Solid Tumors, run by Fujian Cancer Hospital.
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 9 inclusion and 6 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 13 Dec 2022. 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 Meifang Li (15985795022, 362952772@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: up to Day28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2022.