HRYZ-T102 TCR-T Cell for AFP Positive Advanced HCC and Other Solid Tumors
ConditionHepatic Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Ruiliyuan Biotechnology Co., Ltd.
About this trial
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of HRYZ-T102 TCR-T Cell in patients with AFP positive advanced hepatocellular carcinoma and other solid tumors refractory to prior systematic treatments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient must be willing to sign the informed consent form.
Age ≥18 years and ≤75 years.
HLA-A 02:03 allele positive
Histologically-confirmed AFP positive hepatocellular carcinoma (HCC) or other solid tumor, No benefits from curative surgery or other local therapies are expected ,at least one prior line of systematic treatment at screening, judged by investigators.
Disqualifiers
Toxicity of previous treatment has not been mitigated or ≤ Grade 1 at screening.
Another primary malignancy within 5 years (with some exceptions for completely-resected early-stage tumors)
With severe cardiovascular disease or presence of clinically-relevant central nervous system (CNS) disorders in six months before screening.
Systematic autoimmune disorders requiring long-term systematic immunosuppression
Trial design
Design model
Single group
Treatments tested in this trial
AFP Specific T Cell Receptor T Cells
Biological/VaccineAFP Specific T Cell Receptor T Cells On day 1, the TCR-T cells will be administered intravenously. Drug: Fludarabine + Cyclophosphamide Fludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: HRYZ-T102 InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events and serious adverse events
Incidence of adverse events and serious adverse events
Time frame
2 years2
DLT
Dose-limiting toxicity
Time frame
2 yearsSecondary outcomes
1
Objective Response Rate（ORR）
The percentage of subjects with PR or CR assessed by RECIST 1.1.
Time frame
2 years2
Disease Control Rate (DCR)
The percentage of subjects with a confirmed CR, PR, or stable disease (SD) assessed by RECIST 1.1.
Time frame
2 years3
Duration of response (DoR)
Subjects who show a confirmed CR or PR as assessed by RECIST 1.1.
Time frame
2 years4
Time to response (TTR)
Time from date of T-cell administration to first documented evidence of confirmed (CR or PR) as assessed by RECIST 1.1.
Time frame
2 yearsOther outcomes
1
Number of Subjects with positive anti-drug antibodies (ADA)
Serum samples will be collected to analyze for the presence of ADAs using validated immunoassays
Time frame
2 years2
Number of subjects with replication competent lentivirus (RCL)
RCL exposure will be assessed by polymerase chain reaction (PCR) based assay.
Time frame
2 years3
T cell subgroup in peripheral blood
Collect blood samples and analyze for T cell subgroup by flow cytometry at specified intervals before and after treatment with HRYZ-T102.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov