NCT05168748

CD19- and CD22-directed CAR-T Cell Therapy in Patients With Acute Lymphoblastic Leukemia

Phase I, Open Label, Multicenter, Dose Escalation and Expansion Study of IMJ995 in Acute Lymphoblastic Leukemia

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous chimeric antigen receptor (CAR) T cells targeting both CD19 and CD22, manufactured with T-Charge(TM) process. CAR-T cells will be investigated as single agent in pediatric and adult acute lymphoblastic leukemia (ALL).

Detailed description

This is a phase I, open label, multicenter, dose escalation and expansion study of IMJ995. The study will investigate single agent IMJ995 in two independent groups of acute lymphoblastic leukemia (ALL) patients: * Pediatric, adolescent and young adult (AYA) ALL patients up to 29 years old * Adult ALL patients (≥30 years old) safety cohort The pediatric and AYA ALL group consists of two parts: a dose escalation part to evaluate feasibility, characterize safety and identify the recommended dose (RD) of IMJ995, and a dose expansion part to further characterize safety, cellular kinetics and assess preliminary antitumor activity. Once the RD of IMJ995 is determined for this group, the corresponding expansion part may commence. Once the RD of IMJ995 is determined for the pediatric and AYA group, a safety cohort for adult ALL patients ≥30 years old may commence in parallel to the above mentioned expansion part.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	IMJ995 single agent	Single intravenous administration of IMJ995

Timeline

• Start date: 2023-01-24
• Primary completion: 2026-08-13
• Completion: 2026-08-13
• First posted: 2021-12-23
• Last updated: 2022-12-21

Regulatory

• FDA-regulated drug study