NCT07033299

The Safety, Efficacy, and Cellular Metabolic Kinetics of CT1192 in Treating Patients With Anti Neutrophil Cytoplasmic Antibody Associated Vasculitis

A Clinical Study Exploring the Safety, Efficacy, and Cellular Metabolic Kinetics of Universal CD19/20 CAR-T Cell Injection in Anti Neutrophil Cytoplasmic Antibody Associated Vasculitis

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A clinical study exploring the safety, efficacy, and cellular metabolic kinetics of universal CD19/20 CAR-T cell injection in anti neutrophil cytoplasmic antibody associated vasculitis. This study is a single arm, open label, exploratory dose escalation clinical trial aimed at evaluating the safety, efficacy, and cellular metabolic dynamics of CT1192 cells in patients with ANCA associated vasculitis.

Detailed description

The study is divided into dose escalation stage and dose expansion stage. Dose escalation stage The dose escalation is tentatively set at three dose levels, namely 3.0 × 108, 4.5 × 108, and 6.0 × 108 CAR-CD19/CD20+T cells. The expected target toxicity probability for the maximum tolerated dose is 30%, with a planned enrollment of approximately 12 participants. The number of participants in each dose group is subject to actual circumstances. During the experiment, researchers and collaborators will jointly negotiate whether to increase or decrease the dosage based on the participants' cellular metabolic characteristics, safety, tolerability, and preliminary efficacy data, whether to increase to the set highest dose group or produce the maximum cell quantity that can be supplied, and whether to explore new dose levels within the explored dose range (allowing for dose adjustments), in order to determine the possible recommended therapeutic dose (RD). The DLT observation period is 28 days after the first infusion. If the treatment needs to be withdrawn before 28 days after infusion due to disease progression or other reasons, and no significant CAR-T cell expansion is detected or CAR-T therapy is ineffective, and the DLT related AE events determined by the researchers may not be related to the product, the DLT observation period can be completed in advance. When there are safety risks that need to be discussed during each dose escalation, researchers and collaborators can decide when to enter the next dose group based on the safety, tolerability, and metabolic kinetics of CT1192 cells of the participants. Participants in the same dose group need to receive cell infusions at 14 day intervals, and subsequent participants can only receive cell infusions when no significant safety risks (including DLT) are observed. Dose expansion stage Based on the results of the dose escalation phase, one or more dose groups may be selected for dose expansion to further explore the efficacy and safety in ANCA related vasculitis patients. Each dose group and queue are planned to include a maximum of 9 cases, and the specific number of participants is subject to actual conditions. DLT will not be observed during the dose expansion phase, and other research processes will be the same as during the dose escalation phase. Researchers and collaborators will continue to monitor the safety data of the entire dose expansion phase and make entry and exit decisions as necessary.

Conditions

• ANCA Associated Vasculitis (AAV)

Interventions

Type	Name	Description
BIOLOGICAL	CAR-T Therapy	CT1192 cells infusion

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2025-06-24
• Last updated: 2025-06-24

Locations

1 site across 1 country: China