Inaticabtagene Autoleucel Injection Treatment for Adult Relapsed or Refractory Acute Lymphocytic Leukemia

Juventas Cell Therapy

Status: Enrolling

Conditions: B-cell Acute Lymphoblastic Leukemia

Study type: Observational

Funder types: Industry

Identifiers

NCT06450067

HY001402

Details and patient eligibility

About

This clinical trial is a non-interventional, observational, multicenter, post-marketing real-world study to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in Chinese adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

Full description

The study is a non-interventional, observational, multicenter, post-marketing real-world study, and its objective is to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in the treatment of Relapsed or Refractory acute lymphoblastic leukemia. The study consists of screening period including leukapheresis, treatment period, and follow-up period (2 years at most).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years;
2. Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia;
3. Patients deemed eligible for receiving commercial Inaticabtagene Autoleucel injection treatment as determined by the investigator;
4. Patients voluntarily participate in this study and sign an informed consent form. For patients lacking full legal capacity, informed consent must be obtained from their legal guardian

Exclusion criteria

None

Trial design

200 participants in 1 patient group

Diagnosed relapsed or refractory B-cell acute lymphoblastic leukemia

Description:

Diagnosed relapsed or refractory B-cell acute lymphoblastic leukemia