Supercharged immune cells take on Hard-to-Treat cancers
NCT ID NCT07570563
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment made from specially engineered immune cells (T cells) donated by healthy people. The cells are designed to better recognize and kill cancer cells while lasting longer in the body. The trial includes 24 adults with blood cancers or solid tumors that have not responded to standard treatments. The main goal is to check safety and how well the therapy works.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2026
- Expected to finish
-
Dec 2031
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18-75 (inclusive). * Expected survival time ≥ 3 months. * Meets current clinical diagnostic criteria with a confirmed diagnosis of a malignant hematologic tumor or solid tumor, and has failed standard therapy (for solid tumors, at least one evaluable lesion according to RECIST v1.1 is required). * Adequate bone marrow reserve and essentially normal liver and kidney function (laboratory tests must meet the following criteria prior to the first allogeneic TCR-enhanced Vδ2 T cell treatment): * Hematology: White Blood Cell Count (WBC) ≥ 2.5×10⁹/L, Lymphocyte Count (LY) ≥ 0.8×10⁹/L, Hemoglobin (Hb) ≥ 80 g/L, Platelets (PLT) ≥ 75×10⁹/L. * Liver: ALT ≤ 3 × ULN; AST ≤ 3 × ULN; Total Bilirubin ≤ 3.0 × ULN. * Kidney: Serum Creatinine ≤ 1.5 × ULN. * Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by echocardiogram. * Pulmonary: Normal oxygen saturation without supplemental oxygen. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1. * A negative pregnancy test is required for women of childbearing potential. Both male and female subjects must agree to use effective contraception during the treatment period and for 1 year thereafter. * Able to understand the trial requirements and is willing to participate in the clinical study as required. * Voluntarily signs the informed consent form for the clinical trial. Exclusion Criteria: * Known history of allergy, hypersensitivity, intolerance, or contraindication to allogeneic TCR-enhanced Vδ2 T cell or any components of the study drugs (including fludarabine, cyclophosphamide and albumin paclitaxel). * Continuous use of immunosuppressants within 1 month prior to allogeneic TCR-enhanced Vδ2 T cell infusion. * History of cerebrovascular accident or seizure within 6 months prior to signing the informed consent. * Symptomatic brain metastases. * Known psychiatric or substance abuse disorders that would compromise compliance with study requirements. * Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) with detectable Hepatitis B virus (HBV) DNA levels outside the normal reference range; positive for Hepatitis C virus (HCV) antibody with detectable HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibody; positive for syphilis. * Severe cardiac disease, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA Class ≥ III), and severe arrhythmia. * Active or uncontrolled infection requiring systemic therapy (except for mild urogenital and upper respiratory tract infections). * Has not recovered from acute toxic effects of prior therapy (i.e., persisting hematological or organ toxicity ≥ Grade 2 related to prior therapy, excluding abnormalities associated with the study disease and its history). * Diagnosed with immunodeficiency. * Active infection requiring systemic treatment. * Female subjects of childbearing potential planning pregnancy within 2 years after cell infusion; or male subjects whose partners are planning pregnancy within 2 years after cell infusion. * Participation in another investigational drug clinical study within 1 month prior to screening. * Last anti-tumor therapy administered less than 5 half-lives of the drug prior to planned allogeneic TCR-enhanced Vδ2 T cell infusion. * Any other condition deemed by the investigator to make the subject unsuitable for participation in this study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hematologic malignancy are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Biotherapeutic Department of Chinsese PLA Gereral Hospital
RECRUITINGBeijing, Beijing Municipality, 100853, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test
- New injectable drug tested for safety in Hard-to-Treat solid tumors
- Can a Platelet-Boosting drug speed recovery after stem cell transplant?
- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors
- Can regional data improve bone marrow transplant results for blood cancers?
- Could a frailty score predict which older cancer patients survive intensive care?