Long-term follow-up of patients treated with GD2IL18CART

Long-term follow-up of patients treated with GD2IL18CART - GD2IL18CART_Follow-up

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038730

Enrollment

Registered

2026-04-14

Start date

2025-10-06

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C41 C40 C74.1 C50

Interventions

Group 1: Long-term follow-up of patients treated with GD2IL18CART (EU CT No. 2022-501725-21-00). Starts one year after administration of the GD2IL18CART cells. The patients will be followed up for up

Eligibility

Sex/Gender

All

Age

1 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patient underwent treatment with GD2IL18CART in the primary trial prior to enrollment into long-term follow-up. 2. Patient and/or caregivers have provided informed consent at any time prior to the first trial-specific assessment.

Exclusion criteria

Exclusion criteria: No exclusion criteria are defined for this long-term follow-up trial.

Design outcomes

Primary

Measure	Time frame
Percentage of patients with late-onset adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI) including relapse or progression of the underlying disease, life-threatening infections, death due to any cause, new and secondary malignancies.	—

Secondary

Measure	Time frame
Pediatric patients: Height and weight, Tanner status Efficacy endpoints: • Percentage of patients who relapse or progress since enrollment and rate of surviving patients • Probabilities of overall survival, disease-free survival • Duration of response, relapse rate and time to relapse • Percentage of patients with detectable transgene levels. If results of 2 consecutive years are negative for an individual patient, further sampling will not be continued for this patient.	—

Measure

Time frame

Pediatric patients: Height and weight, Tanner status Efficacy endpoints: • Percentage of patients who relapse or progress since enrollment and rate of surviving patients • Probabilities of overall survival, disease-free survival • Duration of response, relapse rate and time to relapse • Percentage of patients with detectable transgene levels. If results of 2 consecutive years are negative for an individual patient, further sampling will not be continued for this patient.

—

Countries

Germany

Contacts

Public ContactClaudia Rössig

Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie -

rossig@ukmuenster.de+49 (0)251 83 47742

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026