RecruitingPhase 1NCT06087341

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

Sponsor

Antonio Pérez Martínez

Enrollment

18 participants

Start Date

Jan 10, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Sarcoma

Summary

Phase I, open label, prospective, single-center, non-randomized, dose escalation clinical trial aiming to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of systemic transduced donor-derived NKG2D-CAR memory T cell infusions (Arm A), and of dual treatment, with both systemic and locally transduced donor-derived NKG2D-CAR memory T cell infusions (Arm B).

Eligibility

Max Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called NKG2D CAR-T cells in young people with sarcoma (bone or soft tissue cancer) that has come back or not responded to standard treatments. These specially engineered immune cells are designed to recognize and attack cancer cells that carry a specific protein marker. **You may be eligible if...** - You are 40 years old or younger - You have any type of sarcoma that has relapsed or not responded to standard therapies - Your cancer expresses the NKG2D ligand protein (confirmed by tumor biopsy) - Your cancer is considered incurable by standard treatments - You have adequate organ function (heart, liver, kidneys) **You may NOT be eligible if...** - Your tumor does not express the required protein marker - You have active HIV, hepatitis B, or hepatitis C infection - You have severe heart, liver, or kidney problems - You are pregnant or breastfeeding - You have had prior gene therapy or CAR-T cell therapy targeting NKG2D Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNKG2D-CAR memory T cell

Patients will be allocated in two groups: Arm A and Arm B. Both groups will receive an intravenous infusion of NKG2D-CAR memory T cells. Additionally, patients on Arm B will receive an intratumoral dose of NKG2D-CAR memory T cells (in accessible primary tumor and metastases). The distribution of patients on one arm or other will depend on their clinical characteristics described in the inclusion/ exclusion criteria. All patients will receive lymphodepleting chemotherapy prior to the infusion of NKG2D-CAR memory T cells according to the usual clinical practice in our center. Some patients will also receive low dose radiotherapy prior to infusion.

Locations(1)

Hospital Universitario La paz

Madrid, Spain

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NCT06087341

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