Malignant Solid TumoursPhase 1/2NCT04765462
Allogeneic γδ T Cell Therapy for the Treatment of Solid Tumors
A Phase 1/2 study testing Allogeneic γδ T cells in people with Malignant Solid Tumours, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The study is to determine the safety, feasibility and efficacy of allogeneic γδ T cell therapy in patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Solid Tumours
- What is being tested?
- Allogeneic γδ T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Dec 2024
- Phase
- Phase 1/2
- 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
- Histological confirmation of malignant solid tumors, including patients received surgery, patients with initially diagnosed or pre-treated local advanced/metastatic malignancies, and patients with B-cell non-Hodgkin's lymphomas.
- Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.
- Age from 18 to 75 years old, gender unlimited.
- Eastern Cooperative Oncology Group (ECOG) Performance score≤2.
- Patient with adequate bone marrow reserve (Haemoglobin≥80g/L, Absolute Neutrophil Count (ANC) ≥1×10^6/L, Platelet≥75×10^9/L or ≥50×10^9/L for liver tumors), hepatic function (Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) ≤ 3.0x upper limit of normal or ≤ 5 x ULN for liver tumors or liver metastases, Total bilirubin ≤ 1.5 x ULN), renal function (Creatinine ≤ 1.5 x upper limit of normal (ULN)) and cardiac function (Left ventricular ejection fraction of ≥50% by ECHO).
- Patient with life expectancy of at least 3 months.
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- Patient without bleeding and coagulation disorders.
- Patient without obvious genetic diseases.
- Toxicity from previous antitumor therapy ≤ grade 1 (according to CTCAE version 5.0) or to an acceptable level of inclusion/exclusion criteria (other toxicities such as alopecia and vitiligo considered by the investigator to pose no safety risk to the subject).
- Male and female patients of reproductive potential must agree to use birth control during the study and for at least 12 weeks post study.
Who cannot join
- Patients who received or are to receive any other cell therapy within 4 weeks before the planned day for the first allogeneic γδ T cell administration.
- Patients who participated or are to participate in other interventional clinical trial within 30 days before the planned day for the first allogeneic γδ T cell administration.
- Uncontrolled serious active infection (such as sepsis, bacteremia and fungemia, HBV, HCV, HIV, TP, CMV or EBV infection).
- Systemic steroid therapy or other immune-suppressants (except in cases where the patient is receiving treatment with replacement doses for adrenal insufficiency).
- Pregnancy or lactation before or during the trial.
- Patients with history of prior organ or bone marrow transplantation.
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- Patients with systemic vasculitis, or with active or uncontrolled autoimmune diseases, as well as primary or secondary immunodeficiency diseases.
- History of epilepsy or other active central nervous system disorders.
- Patients inoculated live vaccine within 6 weeks before screening.
- Allergic constitution, history of allergies to blood products, known to be allergic to any substances in the protocol(such as Zoledronate or similar).
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other medical condition that precludes surgery. Also, psychiatric illness/social situations that would limit compliance with study requirements.
- Any other situations that investigators believe the risk of the subjects is increased or results of the trial are disturbed
- Donor Inclusion Criteria:
- Sign informed consent form.
- Age 18 years up to the age of 50 (≤50), gender unlimited.
- Relative to patients (unrestricted to blood relationship).
- Apheresis available.
- PLT≥100×109/L with normal APTT or PT.
- preculture of γδ T cells meets the requirements of massive amplification and detection.
- Donor Exclusion Criteria:
- History of any severe clinical diseases or other severe organic diseases, including any history of clinically significant systematic diseases such as cardiovascular, urinary, circulatory, respiratory, neurological, psychiatric, digestive and endocrine diseases. History of high blood pressure or systolic pressure>140 mmHg, diastolic pressure>90 mmHg in screening stage. Any situation that investigators believe is clinically significant or with other severe diseases unsuitable of apheresis.
- Arterial thrombosis or venous thrombosis history 12 months prior to the trial or hemorrhagic tendency or history 2 months prior to the trial; oral administration of anticoagulation drugs (e. g. aspirin and warfarin).
- Active or history of autoimmune diseases including but not restricted to SLE, psoriasis, RA, IBD and HT. Apart from hypothyrosis which can be controlled by hormone replacement therapy, skin diseases without systemic therapy and celiac disease which is fully controlled.
- HIV-Ab, TP-Ab, HCV-Ab, HBsAg, HBeAg, HBeAb or HBcAb positive.
- Any symptom, sign or laboratory examination abnormality suggesting acute or subacute infection (e.g. fever, cough, urinary irritation, skin infectious wound).
- Female who are pregnant or cannot stop lactating.
- Those who cannot communicate with medical staff due to mental illness or language disabilities.
- Other unsuitable conditions that investigators believe unsuitable for the donation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Biotherapeutic Department of Chinsese PLA Gereral Hospital
Beijing, Beijing Municipality, 100853
Weidong Han, +861066937463, hanwdrsw69@yahoo.com
About this study
Official title: An Open-label, Phase 1/2 Study of Allogeneic γδ T Cell Therapy for the Treatment of Solid Tumors
The study is to determine the safety, feasibility and efficacy of allogeneic γδ T cell therapy in patients with solid tumors.
Read the detailed description
This is an open-label, single-center, phase 1/2 study to evaluate the safety, feasibility and efficacy of allogeneic γδ T cell therapy. In phase 1 period, a typical 3+3 dose-escalation design will be used to determine the optimal dose level based on the incidence of dose-limiting toxicity (DLT), which will be recommended as the fixed dose level in the following expansion period and phase 2. The initial infusion dose level will start from 2x10^6/kg to 5x10^7/kg in every 2-4 weeks. Combinations with chemotherapy, targeted therapy, radiotherapy, immune checkpoint inhibitors and other therapies are allowed in this study depending on the disease status of the enrolled patients.
- Conditions
- Malignant Solid Tumours
- Being tested
- Allogeneic γδ T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic γδ T cellsBiological
Phase 1:Enrolled patents will be administered allogeneic γδ T cells from 2x10^6/kg, 1 x10^7/kg to 5x10^7/kg every 2-4 weeks to determine the recommended dose level.
Phase 2: Enrolled patents will be administered allogeneic γδ T cells at the recommended dose level to confirm the efficacy.
Whether or not in combination with other therapies will be determined by research physicians according to the disease status of enrolled patients.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic γδ T cell Group | Experimental | Enrolled patients will be administered allogeneic γδ T cells with or without the combinations of traditional therapies, including chemotherapy, targeted therapy, radiotherapy, immune checkpoint inhibitors and others. Receives: Biological: Allogeneic γδ T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT)
The dose escalation strategy will follow the Food and Drug Administration Guideline for design of early phase clinical trials of cellular therapy products.
Measured: Baseline to Day 30
Incidence of severe adverse events
Safety of the γδ T cell infusion will be based on the risk of treatment-related severe adverse events as identified in the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: Baseline to Day 100
Secondary outcomes (5)
Objective Response Rate
Objective clinical response will be assessed by investigators every 2 circles during the treatments and every 2 months after treatment until 2 years after the start of 1st cycle of treatment.
Measured: Baseline to 2years
Duration of Response
The duration of objective response in patients will be recorded until 2years after the start of 1st cycle of treatment
Measured: Baseline to 2years
Overall Survival
Observation for overall survival l (OS) will be recorded until 2years after the start of 1st cycle of treatment.
Measured: Baseline to 2years
Progress Free Survival
Observation for progression-free survival (PFS) will be recorded until 2years after the start of 1st cycle of treatment
Measured: Baseline to 2years
Intervention Treatment-related adverse events(AEs)
Incidence, nature ,and severity of adverse events will be graded according to the NCI CTCAEv5.0.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumoursStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
- Investigators
- Weidong Han, M.D, Principal investigator, Biotherapeutic Department of Chinese PLA General HospitalYanshan Li, Principal investigator, Biotherapeutic Department of Chinese PLA General HospitalKaichao Feng, Principal investigator, Biotherapeutic Department of Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765462
- Sponsor's protocol ID
- CHN-PLAGH-BT-061
- Status last verified
- Sep 2022
- First submitted
- 17 Feb 2021
- Last updated
- 4 Oct 2022
- Results posted
- No
- 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 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1/2 Study of Allogeneic γδ T Cell Therapy for the Treatment of Solid Tumors
- ClinicalTrials.gov ID
- NCT04765462
- Acronym / sponsor ID
- CHN-PLAGH-BT-061
- Conditions
- Malignant Solid Tumours
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Feb 2021 (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.
The study is to determine the safety, feasibility and efficacy of allogeneic γδ T cell therapy in patients with solid tumors.
Detailed description
This is an open-label, single-center, phase 1/2 study to evaluate the safety, feasibility and efficacy of allogeneic γδ T cell therapy. In phase 1 period, a typical 3+3 dose-escalation design will be used to determine the optimal dose level based on the incidence of dose-limiting toxicity (DLT), which will be recommended as the fixed dose level in the following expansion period and phase 2. The initial infusion dose level will start from 2x10^6/kg to 5x10^7/kg in every 2-4 weeks. Combinations with chemotherapy, targeted therapy, radiotherapy, immune checkpoint inhibitors and other therapies are allowed in this study depending on the disease status of the enrolled patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic γδ T cell Group | Experimental | Biological: Allogeneic γδ T cellsEnrolled patients will be administered allogeneic γδ T cells with or without the combinations of traditional therapies, including chemotherapy, targeted therapy, radiotherapy, immune checkpoint inhibitors and others. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histological confirmation of malignant solid tumors, including patients received surgery, patients with initially diagnosed or pre-treated local advanced/metastatic malignancies, and patients with B-cell non-Hodgkin's lymphomas.
- Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.
- Age from 18 to 75 years old, gender unlimited.
- Eastern Cooperative Oncology Group (ECOG) Performance score≤2.
- Patient with adequate bone marrow reserve (Haemoglobin≥80g/L, Absolute Neutrophil Count (ANC) ≥1×10^6/L, Platelet≥75×10^9/L or ≥50×10^9/L for liver tumors), hepatic function (Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) ≤ 3.0x upper limit of normal or ≤ 5 x ULN for liver tumors or liver metastases, Total bilirubin ≤ 1.5 x ULN), renal function (Creatinine ≤ 1.5 x upper limit of normal (ULN)) and cardiac function (Left ventricular ejection fraction of ≥50% by ECHO).
Key exclusion criteria (28 listed)
- Patients who received or are to receive any other cell therapy within 4 weeks before the planned day for the first allogeneic γδ T cell administration.
- Patients who participated or are to participate in other interventional clinical trial within 30 days before the planned day for the first allogeneic γδ T cell administration.
- Uncontrolled serious active infection (such as sepsis, bacteremia and fungemia, HBV, HCV, HIV, TP, CMV or EBV infection).
- Systemic steroid therapy or other immune-suppressants (except in cases where the patient is receiving treatment with replacement doses for adrenal insufficiency).
- Pregnancy or lactation before or during the trial.
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 |
|---|---|---|
| Allogeneic γδ T cellsPhase 1:Enrolled patents will be administered allogeneic γδ T cells from 2x10^6/kg, 1 x10^7/kg to 5x10^7/kg every 2-4 weeks to determine the recommended dose level. Phase 2: Enrolled patents will be administered allogeneic γδ T cells at the recommended dose level to confirm the efficacy. Whether or not in combination with other therapies will be determined by research physicians according to the disease status of enrolled patients. | Biological | Allogeneic γδ T cell Group |
Primary outcome
Incidence of dose-limiting toxicity (DLT)
Time frame: Baseline to Day 30
The dose escalation strategy will follow the Food and Drug Administration Guideline for design of early phase clinical trials of cellular therapy products.
Incidence of severe adverse events
Time frame: Baseline to Day 100
Safety of the γδ T cell infusion will be based on the risk of treatment-related severe adverse events as identified in the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) version 5.
5 secondary outcomes
Objective Response Rate
Time frame: Baseline to 2years
Duration of Response
Time frame: Baseline to 2years
Overall Survival
Time frame: Baseline to 2years
Progress Free Survival
Time frame: Baseline to 2years
Intervention Treatment-related adverse events(AEs)
Time frame: Baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Weidong Han, M.D principal investigator
Biotherapeutic Department of Chinese PLA General Hospital
Yanshan Li principal investigator
Biotherapeutic Department of Chinese PLA General Hospital
Kaichao Feng principal investigator
Biotherapeutic Department of Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogeneic γδ T cells in people with Malignant Solid Tumours, run by Chinese PLA General Hospital 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 10 inclusion and 28 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 4 Oct 2022. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Weidong Han, M.D (+8601066937463, hanwdrsw69@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (DLT) (time frame: Baseline to Day 30). 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 4 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.