Status:
WITHDRAWN
T Cells co- Expressing a Second Generation Glypican 3-specific Chimeric Antigen Receptor With Cytokines Interleukin-21 and 15 as Immunotherapy for Patients With Liver Cancer (TEGAR)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Conditions:
Hepatocellular Carcinoma
Hepatoblastoma
Eligibility:
All Genders
1+ years
Phase:
PHASE1
Brief Summary
This study is for patients that have a type of cancer that arises from the liver, either called hepatocellular carcinoma or hepatoblastoma. The cancer has come back, has not gone away after standard t...
Detailed Description
A maximum of 42 subjects will participate in the treatment part of this study. The investigators will collect up to 180 mL of the participants blood. The investigators will use this blood to grow T c...
Eligibility Criteria
Inclusion
- Procurement Eligibility
- Histology-proven hepatocellular carcinoma (HCC) which is unresectable, recurrent and/or metastatic OR recurrent or resistant hepatoblastoma (HB)
- Barcelona Clinic Liver Cancer Stage A, B or C
- GPC3-positive HCC or HB
- Age ≥ 1 years
- Karnofsky score \>60% (See appendix I)
- Life expectancy \>12 weeks
- Child-Pugh-Turcotte score \<7 (for patients with cirrhosis only)
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
Exclusion
- Heart failure of Class II-IV and / or B-D per NYHA Criteria
- History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)
- History of liver transplantation
- Known HIV positivity
- Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)
- Severe previous toxicity from cyclophosphamide or fludarabine
- Treatment Eligibility
- Inclusion Criteria:
- Histology-proven HCC which is unresectable, recurrent and/or metastatic or relapsed / refractory HB
- Barcelona Clinic Liver Cancer Stage A, B or C
- GPC3-positive HCC or HB
- Age ≥ 1 years
- Life expectancy of ≥ 12 weeks
- Karnofsky score ≥ 60%
- Child-Pugh-Turcotte score \< 8
- Adequate organ function:
- clearance (as estimated by Cockcroft Gault) ≥ 60 ml/min
- serum AST\< 5 times ULN
- total bilirubin \< 3 times ULN for age
- INR ≤1.7
- absolute neutrophil count \> 500/microliter
- platelet count \> 20,000/microliter (can be transfused)
- Hgb ≥9.0 g/dl (can be transfused)
- Pulse oximetry \>90% on room air
- Recovered from acute toxic effects of all prior chemotherapy before entering this study
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion.
- Available autologous transduced CAR T cells
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2038
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04093648
Start Date
January 1 2020
End Date
January 1 2038
Last Update
May 20 2020
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