A phase I safety, dose finding and feasibility trial of GD2IL18CART in patients with relapsed or refractory GD2 positive solid cancers

Conditions

Neuroblastoma, Advanced breast cancer, Ewing sarcoma, Osteosarcoma

Brief summary

Overall incidence and severity of AEs (CTCAE version 5.0), Dose-finding part: RD of GD2IL18CART based on the maximum tolerated dose (MTD) selected by the Bayesian Optimal Interval (BOIN) Design decision rules (posterior DLT estimate closest to target toxicity, i.e. 20%) until day 28 after GD2IL18CART and on the basis of safety and efficacy., Dose extension part: Overall response rate (ORR) defined as the rate of complete (CR) or partial (PR) remissions at week 12 by imRECIST.

Detailed description

In vivo persistence/immune function of GD2IL18CART, Proportion of patients for whom a GD2IL18CART product can be generated, Best response, Duration of response, relapse rate and time to relapse, Disease-free and overall survival at 1 year

Claudia Rössig

Cancer Research2024-09-05

10.1158/1538-7445.pediatric24-ia015

Abstract 6328: Preclinical development of CAR T cells with antigen-inducible IL-18 enforcement to treat GD2-positive solid cancers

Lena Fischer‐Riepe, Sareetha Kailayangiri, Katharina Zimmermann, Rita Pfeifer, Michael Aigner et al. (21 authors)

Cancer Research2024-03-22

10.1158/1538-7445.am2024-6328

Interventions

DRUGCLEMASTINE

DRUGLEVETIRACETAM

DRUGDEXAMETHASONE

DRUGANAKINRA

DRUGPARACETAMOL

DRUGFLUDARABINE

DRUGTOCILIZUMAB

DRUGCYCLOPHOSPHAMIDE

DRUGGD2IL18CART

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
In vivo persistence/immune function of GD2IL18CART, Proportion of patients for whom a GD2IL18CART product can be generated, Best response, Duration of response, relapse rate and time to relapse, Disease-free and overall survival at 1 year	—

Primary

Measure	Time frame
Overall incidence and severity of AEs (CTCAE version 5.0), Dose-finding part: RD of GD2IL18CART based on the maximum tolerated dose (MTD) selected by the Bayesian Optimal Interval (BOIN) Design decision rules (posterior DLT estimate closest to target toxicity, i.e. 20%) until day 28 after GD2IL18CART and on the basis of safety and efficacy., Dose extension part: Overall response rate (ORR) defined as the rate of complete (CR) or partial (PR) remissions at week 12 by imRECIST.	—

Measure

Time frame

Overall incidence and severity of AEs (CTCAE version 5.0), Dose-finding part: RD of GD2IL18CART based on the maximum tolerated dose (MTD) selected by the Bayesian Optimal Interval (BOIN) Design decision rules (posterior DLT estimate closest to target toxicity, i.e. 20%) until day 28 after GD2IL18CART and on the basis of safety and efficacy., Dose extension part: Overall response rate (ORR) defined as the rate of complete (CR) or partial (PR) remissions at week 12 by imRECIST.

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Countries

Germany

Outcome results

None listed