NCT07470073

A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Cell Injection in CD19 and / or CD20 Positive Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia in Adolescents, Children and Adults

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single arm, open label, dose exploring clinical trial to evaluate the safety, efficacy, cellular metabolic dynamics, and pharmacodynamics of ct1190b cells in relapsed / refractory B-cell acute lymphoblastic leukemia.

Detailed description

The study was divided into dose escalation phase and dose expansion phase. It is planned to enroll 18-36 study participants. The participants were divided into two treatment groups. Group A was adult participants ≥ 18 years old who received ct1190b treatment. The dose escalation was tentatively determined at three dose levels: dl1:3.0 × 10\^8, dl2:4.5 × 10\^8, dl3:6.0 × 10\^8 car-t cells. ， Group B consisted of 12-17-year-old adolescents and children. The dose escalation was tentatively defined as two dose levels. Dl1:3.0 × 10\^6 /kg car-t cells, the maximum total number of infused cells was not more than 1.5 × 10\^8 car-t cells, dl2:6.0 × 10\^6 /kg car-t cells, the maximum total number of infused cells was not more than 3.0 × 10\^8 car-t cells. The dose escalation of the two groups followed the "i3+3" design. It was planned to enroll 18-36 study participants. At the dose escalation stage, all patients of different subtypes were mixed into the group. Without distinguishing between groups, the dose escalation of group A was given priority. After obtaining certain data, the dose escalation of group B was performed (fig.it can receive other research data of the same indication of this product). If the starting dose of group A (3.0 × 10\^8) meets the dose reduction standard according to the i3+3 principle (the i3+3 decision table indicates "d" or "Du", refer to the incremental decision table of the i3+3 principle for details), the investigator and the funder will jointly discuss and decide whether to enter the decreasing dose of 1.5 × 10\^8. If the maximum dose currently set is not confirmed as the possible recommended dose (RD), the investigator and the funder can jointly decide whether to increase it to a higher dose to explore the possible recommended therapeutic dose. During the study, the dose group may be increased or decreased or the dose may be extended according to the safety, effectiveness and cellular metabolic dynamics data of the study participants.

Conditions

• ALL (Acute B-Lymphoblastic Leukemia)

Interventions

Type	Name	Description
BIOLOGICAL	CT1190B cell injection	The active ingredient of the drug in this study is the chimeric antigen receptor targeting cd19/cd20 (car-cd19/cd20 for short) modified allogeneic T cells. In order to reduce the rejection of GVHD and host immune cells, TCR and B2M were knocked out, and the related modifications were also carried out to reduce the host NK cell immune rejection.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-31
• Completion: 2028-03-31
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: China