A Phase I Trial of Memory T Cells Expressing an NKG2D Chimeric Antigen Receptor in Children, Adolescents and Young Adults with Advanced Sarcoma

Conditions

Sarcoma

Brief summary

The occurrence of Dose-limiting toxicities (DLTs) in all patients during the study treatment, until 28 days after the last study IV treatment administration and the Maximum Tolerated Dose (MTD) of NKG2D-CAR memory T cells.

Detailed description

Rate of NKG2D-CAR T cells persistence in peripheral blood., Rate of NKG2D-CAR T cells persistence in the tumor and metastasis site., Rate of NKG2DL positive expression on primary sarcoma samples., Cytokine determination in the serum of patients., Obtain primary patient-derived cancer cells from accessible sarcomas, Identify the DNA methylation profile of NKG2DL (MICA, MICB AND ULBPS 1-3) in primary sarcoma samples and DNA methylation profile of NKG2D-T cells before and after infusion., Evaluate the presence of soluble NKG2DL and ANTI-MICA antibodies in the serum of patients under therapy., Analysis of patient peripheral blood immune cell subpopulations, Incidence and severity of adverse events (clinical and laboratory)., Incidence of SAEs., Performance status.

Related papers

No related papers found yet.

Interventions

DRUGCART45RA-NKG2D CELLS

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The occurrence of Dose-limiting toxicities (DLTs) in all patients during the study treatment, until 28 days after the last study IV treatment administration and the Maximum Tolerated Dose (MTD) of NKG2D-CAR memory T cells.	—

Secondary

Measure	Time frame
Rate of NKG2D-CAR T cells persistence in peripheral blood., Rate of NKG2D-CAR T cells persistence in the tumor and metastasis site., Rate of NKG2DL positive expression on primary sarcoma samples., Cytokine determination in the serum of patients., Obtain primary patient-derived cancer cells from accessible sarcomas, Identify the DNA methylation profile of NKG2DL (MICA, MICB AND ULBPS 1-3) in primary sarcoma samples and DNA methylation profile of NKG2D-T cells before and after infusion., Evaluate the presence of soluble NKG2DL and ANTI-MICA antibodies in the serum of patients under therapy., Analysis of patient peripheral blood immune cell subpopulations, Incidence and severity of adverse events (clinical and laboratory)., Incidence of SAEs., Performance status.	—

Measure

Time frame

Rate of NKG2D-CAR T cells persistence in peripheral blood., Rate of NKG2D-CAR T cells persistence in the tumor and metastasis site., Rate of NKG2DL positive expression on primary sarcoma samples., Cytokine determination in the serum of patients., Obtain primary patient-derived cancer cells from accessible sarcomas, Identify the DNA methylation profile of NKG2DL (MICA, MICB AND ULBPS 1-3) in primary sarcoma samples and DNA methylation profile of NKG2D-T cells before and after infusion., Evaluate the presence of soluble NKG2DL and ANTI-MICA antibodies in the serum of patients under therapy., Analysis of patient peripheral blood immune cell subpopulations, Incidence and severity of adverse events (clinical and laboratory)., Incidence of SAEs., Performance status.

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Countries

Spain

Outcome results

None listed