Using engineered T cells to treat certain solid tumors

Interleukin-15 Armored Glypican-3-specific Chimeric Antigen Receptor Expressing Autologous T Cells As Immunotherapy for Patients with SOLID TUMORS (CATCH)

This study is testing a new treatment using specially modified T cells to see if it can help patients with tough-to-treat solid tumors that have a specific protein called GPC3.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Baylor College of Medicine (other)
• Drugs / interventions: CAR T, chemotherapy, prednisone, chimeric antigen receptor, radiation, cyclophosphamide, fludarabine, Cytoxan
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05103631 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a novel treatment approach that combines genetically engineered T cells, known as CATCH T cells, with lymphodepletion chemotherapy to target GPC3-positive solid tumors. Patients with relapsed or refractory cancers that express the GPC3 protein will undergo a process where their T cells are modified to enhance their ability to attack tumor cells. The study aims to assess the safety and effectiveness of this treatment in a Phase 1 setting, with a focus on patients who have not responded to standard therapies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with relapsed or refractory GPC3-positive solid tumors.

Not a fit: Patients with a history of hypersensitivity to murine proteins, organ transplantation, or active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors.

How similar studies have performed: Previous studies using CAR T cell therapies have shown promise in treating various cancers, suggesting potential success for this novel approach.

Eligibility criteria

Procurement Eligibility

Inclusion Criteria:

* Relapsed or refractory 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 ≥18 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 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 organ transplantation
* Known HIV positivity
* Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)

Treatment Eligibility

Inclusion Criteria:

* Age ≥ 18 years
* Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only)
* Life expectancy of ≥ 12 weeks
* 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/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
* 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 (≥ 0.5 mg prednisone equivalent/kg/day, dose adjustment or discontinuation of medication must occur at least 24hrs 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)

Where this trial is running

Houston, Texas

• Houston Methodist Hospital — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Tannaz Armaghany, MD — Baylor College of Medicine
• Study coordinator: Tannaz Armaghany, MD

Conditions: Liver Cell Carcinoma, Solid Tumor, Wilms Tumor, Malignant Rhabdoid Tumor, Yolk Sac Tumor, Rhabdomyosarcoma, Liposarcoma, Embryonal Sarcoma of the Liver