Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma

Plain-language summary

This Phase 1 study tests a gene transfer approach in patients with sarcoma for whom there is no standard treatment or whose current treatments have not worked fully, using the patient's own T cells engineered to recognize HER2. The approach combines two ways of fighting disease, the target-binding property of antibodies and the cell-killing ability of T cells (T lymphocytes); fludarabine (Fludara) and cyclophosphamide (Cytoxan) are also used. Eligibility requires a diagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive osteosarcoma, a Karnofsky/Lansky score of 50 or greater, and informed consent.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Active, not recruiting

Sponsor

Baylor College of Medicine

Intervention

Autologous HER2-specific T cells, Fludarabine (Fludara), Cyclophosphamide (Cytoxan), Autologous CAR Positive T cells

Start date

2/11/2010

Estimated completion

7/1/2032

Countries

United States

Related genes

Locations

• Houston, United States
• Houston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

INCLUSION CRITERIA:

Procurement Eligibility:

1. Diagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive osteosarcoma.
2. Karnofsky/Lansky score of 50 or greater
3. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

Treatment Eligibility:

1. Diagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive sarcoma with disease progression after receiving at least one prior systemic therapy.
2. Recovered from acute toxic effects of all prior cytotoxic chemotherapy at least 4 weeks before entering this study. PD1/PDL1 inhibitors will be allowed to continue during treatment if medically indicated.
3. Normal ECHO (Left ventricular ejection fraction (LVEF) has to be within normal, institutional limits)
4. Life expectancy 6 weeks or greater
5. Karnofsky/Lansky score of 50 or greater
6. Bilirubin 3x or less, AST 3x or less, Serum creatinine 2x upper limit of normal or less, Hgb 7.0 g/dl or greater, WBC greater than 2,000/ul, ANC greater than 1,000/ul, platelets greater than 100,000/ul. Creatinine clearance is needed for patients with creatinine greater than 1.5 times upper limit of normal.
7. Pulse oximetry of 90% or greater on room air
8. Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. Male partner should use a condom
9. Available autologous transduced T lymphocytes with 15% or more expression of HER2 CAR as determined by flow-cytometry and killing of HER2-positive targets 20 % or greater in cytotoxicity assay.
10. Chest radiograph for baseline evaluation of lungs
11. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent

EXCLUSION CRITERIA:

At time of Procurement:

1. Known HIV positivity
2. Severe previous toxicity from cyclophosphamide or fludarabine

At time of Treatment:

1. Severe intercurrent infection
2. Known HIV positivity
3. Pregnant or lactating
4. History of hypersensitivity reactions to murine protein-containing products
5. Severe previous toxicity from cyclophosphamide or fludarabine