Allogeneic B7H3 CAR-γδT Cell Therapy for Advanced Solid Tumors
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University
About this trial
γδT cells can directly recognize non-peptide tumor antigens, such as IPP phosphorylated metabolites, without relying on specific major histocompatibility complexes (MHCs). This unique characteristic leads to a lower risk of graft-versus-host disease (GVHD). The clinical safety of γδT cells in allogeneic tumor therapies has been validated multiple times, highlighting their significant potential in developing universal CAR-T cell therapies.
B7H3 (CD276), a member of the B7 negative co-stimulatory molecule family, is minimally expressed or absent in normal tissues but highly expressed in various tumor tissues. As a result, B7H3 is regarded as a highly promising tumor-associated antigen and a universal drug target with substantial therapeutic potential.
By utilizing γδT cells as carrier cells, the development of universal B7H3 CAR-γδT cell injections for advanced solid tumors can effectively address risks such as autologous cell preparation failure and treatment delays. This innovative approach offers a highly efficient solution for solid tumor treatment and holds great promise for advancing immunotherapy in this field
Eligibility criteria
Qualifiers
Age ≥18 years old, gender is not limited;
Expected survival time ≥3 months;
ECOG score 0~1;
Patients who meet the clinical diagnostic criteria and have a clear pathological diagnosis of malignant solid tumors that have failed standard treatment;
Disqualifiers
Known hypersensitivity, allergy, intolerance, or contraindication to cell infusion or any of the drug components that may be used in the study, including fludarabine and cyclophosphamide;
Patients who have been continuously using immunosuppressive drugs within 1 month prior to cell infusion;
Cerebrovascular accident or seizure within 6 months prior to signing the informed consent form;
Symptomatic brain metastases;
Trial design
Treatments tested in this trial
- Fludarabine
- Cyclophosphamide
- B7H3 CAR-γδT cells
Treatment groups
18 Participants
are divided into 2 treatment groupsSponsors and collaborators
Peking University
Lead sponsor
Peking University Cancer Hospital & Institute
Sponsor institution
Source ClinicalTrials.gov