TP53 R248Q TCR-T Cell Therapy for Advanced Solid Tumor
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About this trial
To evaluate the safety and efficacy of T cell therapy with mutated TP53 R248Q specific TCR transduction in patients with advanced solid tumor expressing the TP53 R248Q mutation and the HLA-A\*11:01 allele.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
signed a written informed consent form (ICF), and can comply with protocol-specified visits and related procedures;
aged ≥ 18 years, and ≤ 75 years, male or female;
subjects with TP53R248Q mutation in genetic testing, as determined by DNA or RNA sequencing methods;
if patients with brain metastases are asymptomatic and less than 3 brain lesions less than 3 cm in diameter, they may be eligible;
Disqualifiers
previous bone marrow or organ transplantation (including but not limited to liver transplantation) or waiting for transplantation;
previous or concurrent history of other malignancies (cured and at least 2 years before screening without recurrence of cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer or radical treatment of local prostate cancer, radical resection of ductal carcinoma in situ can be enrolled in the study);
hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and HBV DNA > 500 IU/mL (lower limit of detection < HBV DNA ≤ 500 IU/mL, clear lymphocyte conditioning medication before the need for at least 14 days of antiviral therapy and continuous antiviral therapy during the study can be enrolled); hepatitis C virus (HCV) antibody positive and HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive;
HLA antibody positive subjects, including weak positive, positive and strong positive (those with different HLA typing sites from TP53R248QTCR-T cell injection can be enrolled in the study);
Trial design
Design model
Single group
Treatments tested in this trial
Autologous, engineered T Cells targeting TP53 R248Q
Biological/VaccineTP53-R248Q mutant TCR-T Cells Injection, 28 days as a treatment cycle (cycle number N≤3), each cycle was divided into three D0, D7, D14 infusion, a total of 3 dose groups were set up, the single infusion of cells within the range of ±20% all meet the requirements
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: TP53 R248Q specific TCR transduction T cell therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Short term Safety of TP53-R248Q TCR-T cell injection in subjects with unresectable, advanced, and/or metastatic solid tumors
Incidence of dose-limiting toxicities (DLTs) after the infusion of TP53-R248Q TCR-T cell injection;
Time frame
28 days after infusion2
Long term Safety of TP53-R248Q TCR-T cell injection in subjects with unresectable, advanced, and/or metastatic solid tumors
Incidence of adverse events and serious adverse events; Treatment-emergent adverse events, and serious adverse events
Time frame
28 days after infusion and up to 24 months after infusionSecondary outcomes
1
Preliminary anti-tumor activity of TP53-R248Q TCR-T cell injection in subjects with unresectable, advanced, and/or metastatic solid tumors
Objective Response Rate (ORR) per RECIST V1.1 determined by Investigator assessment.
Time frame
Up to 24 months after infusionSponsors and contacts
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Source ClinicalTrials.gov
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