Study Of B7H3 CAR-T Cells in Treating Advanced Liver Cancer
NCT ID: NCT05323201
Last Updated: 2022-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2022-02-10
2027-02-10
Brief Summary
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Detailed Description
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Previous studies have confirmed that B7H3 is highly expressed in hepatocellular carcinoma cell lines, which is negatively correlated with the ten-year survival of patients. It is suggested that B7H3 is a specific therapeutic target for liver cancer.
The purpose of this study is to test the safety and efficacy of a newly developed fully human scFv-armed B7H3 targeting chimeric antigen receptor T cells (fhB7H3.CAR-Ts), which are supposed to attack and eliminate B7H3-positive cancer cells.
The investigators designed a single-arm open-label clinical study, the participants' peripheral blood mononuclear cells will be collected and used to manufacture fhB7H3.CAR-Ts. Before infusion, the patients will receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine for three consecutive days. Two days later after lymphodepletion, the fhB7H3.CAR-Ts would be given through transhepatic arterial infusion. From the day of infusion, participants' peripheral blood will be collected twice a week in the first month to monitor the survival of fhB7H3.CAR-Ts and evaluate the therapeutic efficacy. Additional follow-up and examination will be performed monthly for the first three month and then trimonthly until two year. Thereafter, annual follow-up will be completed for 5 years.
This is an investigator-initiated clinical study to assess clinical performance of novel fhB7H3.CAR-Ts which may help other advanced and recurrent liver cancer patients in the future.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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fhB7H3.CAR-T cells
In phase I study , 9 enrolled patients diagnosed with advanced liver cancer will receive one-time transhepatic arterial infusion of fhB7H3.CAR-Ts at the doses of 1×10\^6/kg, 3×10\^6/kg and 5×10\^6/kg, 3 patients for each dose. To further confirm the therapeutic efficacy, in phase II study, 6 enrolled patients will receive an optimal dose (balancing effectiveness and toxicity) of fhB7H3.CAR-Ts.
fhB7H3.CAR-Ts
fhB7H3.CAR-Ts will be transhepatic arterial infused after lymphodepletion. Three dose levels will be evaluated: Dose Level 1 (1×10\^6/kg), dose Level 2 (3×10\^6/kg) and dose Level 3 (5×10\^6/kg). If dose limiting toxicities (DLTs) are observed in each doses, Dose Level -1 (0.5×10\^6/kg /infusion) will be evaluated.
Fludarabine
30 mg/m2 i.v. for 3 consecutive days (Day -5\~Day -3)
Cyclophosphamide
750 mg/m2 i.v. for once (Day -5)
Interventions
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fhB7H3.CAR-Ts
fhB7H3.CAR-Ts will be transhepatic arterial infused after lymphodepletion. Three dose levels will be evaluated: Dose Level 1 (1×10\^6/kg), dose Level 2 (3×10\^6/kg) and dose Level 3 (5×10\^6/kg). If dose limiting toxicities (DLTs) are observed in each doses, Dose Level -1 (0.5×10\^6/kg /infusion) will be evaluated.
Fludarabine
30 mg/m2 i.v. for 3 consecutive days (Day -5\~Day -3)
Cyclophosphamide
750 mg/m2 i.v. for once (Day -5)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject has adequate performance status as defined by ECOG score of≤ 2.
3. Expected life expectancy is no less than 12 weeks.
4. Subjects must have histologically or cytologically confirmed unresectable, recurrent and / or metastatic hepatocellular carcinoma (HCC). And tumor tissues are measured positive for B7H3 expression.
5. Child-Pugh A, B grade.
6. Blood routine:
white blood cell count≥ 2.5 × 10\^9 / L; hemoglobin≥ 9 g/dL; platelet count≥ 50 × 10\^9 / L; lymphocyte proportion≥ 15 %;
7. Adequate organ function. Patients' main organs ( heart, lung, liver, kidney, etc. ) function well:
ALT and AST≤ 5 × ULN; ALB≥ 30 g/L； Total bilirubin≤ 2.5 × ULN； Serum creatinine\< 220μmol/L; Indoor oxygen saturation ≥ 95 %; Left ventricular ejection fraction≥ 40%;
8. No allergic reaction to contrast agents.
9. Procurement and T-cell production eligibility: a previously evaluation confirmed autologous peripheral blood mononuclear cells can be used for T-cell production.
10. Patients or their legal guardians voluntarily participate in and sign the informed consent form.
Exclusion Criteria
2. The subjects have infectious diseases (such as HIV, syphilis, active tuberculosis, etc.);
3. The subject has active infection or coagulation dysfunction.
4. Subjects with previous hepatic encephalopathy.
5. The subject is on anticoagulation or antiplatelet therapy.
6. The subject is an organ transplant or waiting for transplant.
7. Subjects with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation.
8. The subjects are highly allergic or have a history of severe allergies.
9. The subject has received chemotherapy/radiotherapy within the past 4 weeks.
10. The subject has a history of cellular immunotherapy or antibody therapy.
11. The subject is receiving systemic hormone therapy.
12. Subjects with systemic infection or severe local infection requiring anti-infection treatment.
13. The subject has dysfunction of important organs such as heart, lung, brain, liver, and kidney.
14. The subject is participating in other clinical research.
15. The doctor believes that there are other reasons not to be included in the treatment.
16. Unwilling or unable to provide consent/assent for participation in the study.
18 Years
70 Years
ALL
No
Sponsors
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Xuzhou Medical University
OTHER
IIT MediTech Co. Ltd
UNKNOWN
The Affiliated Hospital of Xuzhou Medical University
OTHER
Responsible Party
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Locations
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The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Countries
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Facility Contacts
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Other Identifiers
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XYFY2021-KL272-02
Identifier Type: -
Identifier Source: org_study_id
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