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Advanced Solid TumorPhase 1NCT06404281

γδ T-PD-1 Ab Cells in the Treatment of Advanced Solid Tumors

A Phase 1 study testing γδ T-PD-1 Ab cells in people with Advanced Solid Tumor, run by Changzhou No.2 People's Hospital at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study intends to combine the advantages of γδ T cells and PD-1 monoclonal antibody to conduct an exploratory clinical study on the safety and efficacy of PD-1 antibody armored γδ T cells (γδ T-PD-1 Ab cells) in the treatment of advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Advanced Solid Tumor
What is being tested?
γδ T-PD-1 Ab cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
1 Aug 2024to 1 Jun 2026
Phase
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The patient voluntarily signs the informed consent and can complete the follow-up examination, evaluation and treatment;
  • Age 18-80 years old, gender is not limited;
  • The histopathological diagnosis was malignant solid tumor;
  • Clinical or pathological was stage IV according to AJCC 8th edition stage;
  • Subjects with advanced solid tumors without standard treatment options;
  • ECOG score 0-1;
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  • Expected survival ≥6 months;
  • Have at least one evaluable lesion according to RECIST 1.1 criteria;
  • Organ function level requirements (no blood transfusion or blood products, no hematopoietic stimulating factors, no albumin or blood products used within 14 days prior to the first dose);
  • Bone marrow function: absolute value of neutrophils (ANC) ≥1.5×109, platelets ≥75×109, and hemoglobin (Hb) ≥90g/L;
  • Liver function: total bilirubin ≤1.5 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN (5.0 times ULN if liver metastasis is present), alkaline phosphatase < 5 × ULN;
  • Renal function: serum creatinine level ≤2 ULN, creatinine clearance > 50mL/min (according to Cockcroft-Gault formula); Urine protein <2+(If urine protein ≥2+, urine protein measurement should be collected for 24 hours, and the total amount should be <1g to be allowed to enter the group);
  • The serum pregnancy test of women of childbearing age in the 7 days prior to Gamma-delta T-PD-1 Ab infusion is negative, and any fertile male and female subject must consent to the use of an effective contraceptive method throughout the study and for at least 12 weeks after the last study administration. In the researchers' judgment, a subject is fertile: he/she is biologically capable of having children and having a normal sex life.
  • A hysterectomy or bilateral oophorectomy has been performed, or ovarian failure has been medically confirmed, or post-menopause has been medically confirmed (menopause for at least 12 consecutive months without pathological or physiological causes).

Who cannot join

  • Intolerance or allergy to any ingredient or similar drug in the treatment plan planned for this study;
  • Metastasis of symptomatic central system;
  • Have received other cell therapies, including NK, CIK, DC, CTL, CAR-T, TCR-T, and stem cell therapy in the past 4 weeks;
  • Received systemic steroid therapy (> 10 mg/kg prednisone or equivalent) or any other form of immunosuppressive medication within two weeks prior to the first dose; Corticosteroids (≤10mg oral prednisone or equivalent) were used in subjects with chronic obstructive pulmonary disease, saline corticosteroids (such as hydrohydrocortisone) were used in subjects with postural hypotension, and low-dose supplemental corticosteroids were used in subjects with adrenal insufficiency.
  • Plan to use any other form of systemic antitumor therapy during the study period;
  • History of known hematological malignancy, primary brain tumor or sarcoma, or other primary solid tumor within 6.5 years, unless cured and no evidence of recurrence of the disease within 5 years. With the exception of cured basal cell carcinoma of the skin and cervical carcinoma in situ;
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  • History of interstitial lung disease, non-infectious pneumonia or uncontrolled disease, including pulmonary fibrosis and acute lung disease;
  • Active autoimmune diseases within the past 2 years requiring systemic treatment (such as glucocorticoids or immunosuppressive drugs), and related replacement therapy (such as thyroxine, insulin, or physiologic glucocorticoid replacement therapy for renal or pituitary insufficiency); Bisphosphonates were administered within 2 months prior to Γδ T-PD-1 Ab infusion.
  • Known subjects had systemic vasculitis, co-active or uncontrolled autoimmune disease, primary or secondary immune deficiency, graft-versus-host disease (GvHD).
  • Hepatitis B infection, hepatitis C infection, human immunodeficiency virus (HIV) infection, Treponema pallidum (TP) infection.
  • Had undergone major surgery within 4 weeks prior to screening that was assessed by the investigator as unsuitable for enrollment.
  • Acute infection and gastrointestinal bleeding occurred in 4 weeks.
  • Major organ dysfunction: absolute value of neutrophils (ANC) < 1.5×109, platelets < 75×109, and hemoglobin (Hb) < 90g/L; Serum albumin < 28g/L, total bilirubin >51μmol/L, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the upper limit of normal, creatinine > 1.5 times the upper limit of normal; Have abnormal coagulation function (INR > 1.5 or PT >1.2 ULN or PTT >1.2 ULN), have a tendency to bleed, or are receiving thrombolytic or anticoagulant therapy.
  • The subject's heart meets any of the following conditions: Left ventricular ejection fraction (LVEF) ≤45%; New York Heart Association (NYHA) Class III or IV congestive heart failure; QTcB > 450 msec; Other heart conditions that the investigators judged unsuitable for inclusion.
  • People with a history of epilepsy or other active central nervous system diseases.
  • Received live vaccine within 6 weeks prior to screening, and received hematopoietic stimulating factors, such as colony-stimulating factor and erythropoietin, within 2 weeks prior to treatment; Major surgical procedures (excluding diagnostic surgical procedures) within 4 weeks before the start of treatment;
  • Evidence of uncontrolled and severe active infection at the time of screening (e.g., sepsis, bacteremia, fungemia), or a recent (within 4 months) history of deep tissue infection (e.g., fasciitis or osteomyelitis).
  • Participate in other interventional clinical investigators within 3 months prior to infusion of γδ T-PD-1 AB-PD-1 Ab.
  • A known mental or substance abuse disorder may interfere with the requirement to cooperate in the completion of the trial.
  • Women who are pregnant or breastfeeding, or who plan to become pregnant or have children during the study period.
  • In the investigator's judgment, the subject has any serious acute or chronic physical or mental illness, or laboratory abnormalities that could increase the risk of study participation, study administration, or possibly affect the interpretation of study results.

Trial locations and contacts

1 site in 1 country.

Hua Jiang, MD contact

+86-18015852711

czeyjh@njmu.edu.cn

China1 site, 1 recruiting

  • Changzhou No.2

    Changzhou

    Hua Jiang, MD

    Recruiting

Other trials in China

About this study

Official title: Anti-PD-1 Antibody Armored γδ T Cells in the Treatment of Advanced Solid Tumors, a Phase I Clinical Trail

This study intends to combine the advantages of γδ T cells and PD-1 monoclonal antibody to conduct an exploratory clinical study on the safety and efficacy of PD-1 antibody armored γδ T cells (γδ T-PD-1 Ab cells) in the treatment of advanced solid tumors.

Read the detailed description

This is a single-center, single-arm, phase I clinical trial to evaluate the safety and efficacy of γδ T-PD-1 Ab cells in patients with advanced solid tumors without standard treatment. A typical 3+3 dose-escalation design will be used to determine the optimal dose level of γδ T-PD-1 Ab cells based on the incidence of dose-limiting toxicity (DLT). The initial infusion dose level will start from 3×10^7/kg to 3×10^8/kg in every 2 weeks.

Being tested
γδ T-PD-1 Ab cells

What participants receive

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

  • γδ T-PD-1 Ab cellsBiological

    Cells will be extracted from a healthy donor, followed by ex-vivo expansion, activation and genetic engineering. The ex-vivo expanded γδ T-PD-1 Ab cells will be adoptively transfused to tumor patients.

Study groups in NCT06404281
Study groupRoleWhat they receive
γδ T-PD-1 Ab cellsExperimentalPatients will receive 6 cycles of ex-vivo expanded γδ T-PD-1 Ab cells treatments,at two-weeks' intervals.γδ T-PD-1 Ab cells are transfused to patients in atypical 3+3 dose-escalation design(Dose escalation,3x10^7/kg,1x10^8/kg,3x10^8/kg).
Receives: Biological: γδ T-PD-1 Ab cells

What is being measured

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

  1. Safety evaluation: Incidence of Adverse events (AEs)

    Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

    Measured: up to 60 weeks

  2. Safety evaluation: Dose limited toxicity (DLTs)

    The incidence, characteristic and severity of DLTs will be recorded and assessed.

    Measured: up to 60 weeks

  3. Safety evaluation: Maximum-tolerated dose (MTD)

    MTD or clinical recommended dose will be recorded and evaluated.

    Measured: up to 60 weeks

Secondary outcomes (4)

  1. Efficacy evaluation: Objective Response Rate(ORR)

    Objective response rate will be assessed by investigators.

    Measured: up to 15months

  2. Efficacy evaluation: Disease Control Rate (DCR)

    Disease Control Rate will be assessed by investigators.

    Measured: up to 15months

  3. Efficacy evaluation: Progress Free Survival(PFS)

    Observation for progression-free survival (PFS) will be recorded until 15 months after the start of 1st cycle of treatment.

    Measured: up to 15months

  4. Efficacy evaluation: Overall Survival (OS)

    Observation for overall survival (OS) will be recorded until 15 months after the start of 1st cycle of treatment.

    Measured: up to 15months

Timeline

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

  1. First posted8 May 2024
  2. Study start1 Aug 2024
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jun 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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06404281
Sponsor's protocol ID
[2024]KY024-01
Status last verified
Aug 2024
First submitted
21 Apr 2024
Last updated
22 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing γδ T-PD-1 Ab cells in people with Advanced Solid Tumor, run by Changzhou No.2 People's 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 14 inclusion and 21 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 22 Aug 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hua Jiang, MD (+86-18015852711, czeyjh@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety evaluation: Incidence of Adverse events (AEs) (time frame: up to 60 weeks). 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 NCT06404281.

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 22 Aug 2024.

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