Status:
ACTIVE_NOT_RECRUITING
Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
National Institutes of Health (NIH)
Conditions:
Liver Cancer
Rhabdomyosarcoma
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
Brief Summary
Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cell...
Detailed Description
Approximately 15-24 subjects will participate in the treatment part of this study. Maximum of 180 mL of blood (not exceeding 3ml/kg/day) is collected from patients to grow the T cells and a retroviru...
Eligibility Criteria
Inclusion
- Procurement Eligibility
- 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 ≥ 1 year and ≤ 21 years
- Life expectancy of ≥ 16 weeks
- Lansky or Karnofsky score ≥60%
- Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only
- 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
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)
- Actively progressing CNS metastases
- Treatment Eligibility
- Inclusion Criteria:
- Age ≥ 1 year and ≤ 21 years
- Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only)
- Lansky or Karnofsky score ≥ 60%
- Child-Pugh-Turcotte score \< 7 (for patients with hepatocellular carcinoma only)
- Adequate organ function:
- Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml/min
- serum AST\< 5 times ULN
- total bilirubin \< 3 times ULN for age
- INR ≤1.7 (for patients with hepatocellular carcinoma only)
- absolute neutrophil count \> 500/microliter
- platelet count \> 25,000/microliter (can be transfused but must be at that level prior to treatment)
- Hgb ≥7.0 g/dl (can be transfused but must be at that level prior to treatment)
- 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
- 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
- Exclusion Criteria
- Pregnancy or lactation
- Uncontrolled infection
- Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day, dose adjustment or discontinuation of medication must occur at least 24 hours prior to CAR T cell infusion)
- Known HIV positivity
- Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)
- History of organ transplantation
- 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)
- Actively progressing CNS metastases
Key Trial Info
Start Date :
August 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2040
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04377932
Start Date
August 8 2021
End Date
August 26 2040
Last Update
November 17 2025
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030