A Phase I Trial of Memory T Cells Expressing an NKG2D Chimeric Antigen Receptor in Children, Adolescents and Young Adults With Advanced Sarcoma (CAR4SAR)

NCT06087341 Phase 1 RECRUITING

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).

Details

Lead sponsor	Antonio Pérez Martínez
Phase	Phase 1
Status	RECRUITING
Enrolment	18
Start date	2024-01-10
Completion	2028-04

Conditions

• Advanced Sarcoma

Interventions

• NKG2D-CAR memory T cell

Primary outcomes

• Safety: Dose-limiting toxicity (DLT) of NKG2D-CAR memory T cells — During the study treatment, until 28 days after the last study iv treatment administration
  1. Any grade 3 or higher toxicity with an attribution of definitely or probably related to the infusion of the NKG2D CAR-T cells with the exception of Grade 3 fever and immediate hypersensitivity reactions occurring within 2hours of cell infusion that are reversible to a Grade 2 or less within 24 hours of cell administration with standard therapy; 2. Any lower grade toxicity that increases to a grade 3 or higher as a direct result of the NKG2D CAR-T cell infusion.
• Safety: Maximum Tolerated Dose (MTD) of NKG2D-CAR memory T cells — During the study treatment, until 28 days after the last study iv treatment administration
  The highest dose level if no Dose-limiting toxicitys are observed
• Response rate — At day 60 after the treatment
  This outcome will be evaluated by Immune-Related Response Criteria (iRECIST) v1.1. The efficacy will be measured by objective response rate (ORR) at D60 in both arms, which includes Complete Response (CR) and Partial Response (PR) based on Immune-Related Response Criteria iRECIST v1.1.

Countries

Spain