Status:
RECRUITING
Immunotherapy For Adults With GPC3-Positive Solid Tumors Using IL-15 and IL-21 Armored GPC3-CAR T Cells
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Hepatoblastoma
Hepatocellular Carcinoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T ce...
Detailed Description
The study team will collect up to 18 teaspoons of patients' blood. This will be used this blood to grow T cells. The study team then grows the T cells and uses a retrovirus (a special virus that can i...
Eligibility Criteria
Inclusion
- Procurement
- Diagnosis of GPC3-positive\* solid tumors (as determined by immunohistochemistry with an extent score of \>=Grade 2 \[\>25% positive tumor cells\] and an intensity score of \>= 2 \[scale 0-4\]).
- Age ≥21 years
- Lansky or Karnofsky score ≥60%
- Life expectancy ≥16 weeks
- Barcelona Clinic Liver Cancer Stage A, B or C (- Child-Pugh-Turcotte score \<7 (for patients with hepatocellular carcinoma only)
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent \* GPC3 expression will be evaluated by standard immunohistochemistry (IHC) at Texas Patients's Hospital/Baylor College of Medicine, Department of Pathology for all patients to meet procurement eligibility. All patients will send at least 5 unstained slides.
- Procurement
Exclusion
- 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 organ transplantation
- Known HIV positivity
- Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)
- Treatment Inclusion Criteria:
- Diagnosis of GPC3-positive solid tumor
- Age ≥ 21 years
- Barcelona Clinic Liver Cancer Stage A, B or C
- Life expectancy of ≥ 12 weeks
- Lansky or Karnofsky score ≥ 60%
- Child-Pugh-Turcotte score \< 7
- Adequate organ function:
- Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml/min
- total bilirubin \< 3 times ULN for age
- INR ≤1.7 (for patients with hepatocellular carcinoma only)
- absolute neutrophil count \> 500/µl
- platelet count \> 25,000/µl (can be transfused)
- Hgb ≥ 7.0 g/dl (can be transfused)
- Pulse oximetry \>90% on room air
- Refractory or relapsed disease after treatment with up- front therapy and at least one salvage treatment cycle
- Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study, as determined by history and physical exam
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion.
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
- Treatment
Key Trial Info
Start Date :
June 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2043
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06198296
Start Date
June 10 2025
End Date
February 1 2043
Last Update
November 3 2025
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030