A Clinical Study of IL13Rα2 Targeted CAR-T in Patients With Malignant Glioma (MAGIC-I)

Phase 1

Recruiting

• Conditions: Recurrent Malignant Glioma
• Interventions: Drug: YYB-103

• Registration Number: NCT05540873
• Lead Sponsor: CellabMED

Brief Summary

This is a phase I study to evaluate the safety and tolerability of IL13Rα2 Targeted Chimeric Antigen Receptor-T Cell in patients with Refractory or Recurrent Malignant Glioma and to evaluate the changes of AE incidence.

And this study have to long term follow-up.

Detailed Description

This is a single-center, single-arm, open-label phase 1 study that will follow a 3 + 3 design of dose-escalating cohorts. The objectives of this study is to assess the safety and tolerability after administration of YYB-103 (IL13Rα2 targeted CAR-T cell) in patients with malignant glioma.

YYB-103 is designed to target cancer cells expressing IL13Rα2 in cell surface. Only those subjects who are expressing IL13Rα2 and satisfy the inclusion and exclusion criteria will receive IV infusion of YYB-103.

Long term follow-up study is evaluate the safety and exploratory efficacy of IP for 15 years from the date of IP administration in patients with malignant glioma refractory or recurrent to standard therapy who participated in this study.

Subjects who participated in the Phase 1 study and received YYB-103 must have long-term follow-up for 15 years from the date of administration. During the long-term follow-up period, AEs, exploratory efficacy etc. are observed, and the observation period is every 6 months within 5 years and then yearly until 15 years.

Study Timeline

• Study Start: 2022-07-18
• Study First Submitted: 2022-08-28
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-15
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-06
• Primary Completion: 2024-02-28
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IL13Rα2 targeted CAR-T	YYB-103	-

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity (DLT)	28 days after IP administration
Maximum Tolerance Dose (MTD)	28 days after IP administration
Recommended Phase 2 Dose (RP2D)	28 days after IP administration

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics and cytokine levels	3 months, up to 15 years if necessary	Peripheral blood (PB) and Cerebral spinal fluid (CSF)
Incidence of AE	3 months, up to 15 years if necessary	CRS and ICANS (ASTCT) / Others (CTCAE V5.0)
RCR	1 year, up to 15 years if necessary	RCR formation will be checked by collecting samples at 3M, 6M, and every 6 months thereafter until 5 years from IP administration, and then will be followed up annually thereafter until 15 years from IP administration via medical history without collecting samples. If all RCR test results are negative for 1 year after IP administration, sample collection will be stopped, and annual follow-up.
Disease response (DCR)	Baseline up to 6 months	Tumor response will be assessed by comparison with baseline magnetic resonance imaging by iRANO criteria. Evaluation of DCR is the proportion of subjects with CR or PR or SD as a result of tumor response assessment.

Trial Locations

Locations (1)

National Cancer Center, Korea; 🇰🇷 Goyang-si, Gyeonggi, Korea, Republic of