Status:
RECRUITING
Interleukin-15 and -21 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
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 18-30 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
- Lansky or Karnofsky score ≥60%
- Life expectancy ≥16 weeks
- 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)
- 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
- Total bilirubin \< 3 times ULN for age
- INR ≤1.7 (for patients with hepatocellular carcinoma only)
- Absolute neutrophil count \> 750/µl
- Platelet count \> 75,000/µl (Needs to be confirmed prior to treatment whether with or without transfusion)
- Hgb ≥ 8.0 g/dl (Needs to be confirmed prior to treatment whether with or without transfusion)
- Pulse oximetry ≥ 92% on room air
- Incurable disease after treatment with up- front therapy (Patients who have relapsed disease despite a standard of care salvage therapy)
- Wash out period, such that patient has recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study, and returned to their clinical baseline, as determined by history and physical exam.
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the T-cell infusion.
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
Key Trial Info
Start Date :
May 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 3 2041
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04715191
Start Date
May 24 2024
End Date
July 3 2041
Last Update
May 2 2025
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030