Trials / Recruiting

RecruitingNCT06718270

a Study of CT0596 in Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Plasma Cell Leukemia

A Clinical Study to Explore the Safety, Efficacy, and Pharmacokinetics of CT0596 CAR-T Cell Injection in Patients With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Plasma Cell Leukemia

Status: Recruiting
Phase: EARLY_Phase 1
Study type: Interventional
Enrollment: 24 (estimated)

Sponsor: Shanghai Changzheng Hospital · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

Detailed description

This study is a single-arm, open-label, exploratory dose-escalation and dose-finding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with R/R MM and PCL.RRMM and RRpPCL. During the trial, dose increases or decreases or dose expansion may be performed using i3+3 principle based on the safety and ,tolerability and PK data of the patients. All Patients will undergo a DLT assessment period which is defined as the first 28 days starting from the day of CT0596 infusion. A patient is evaluable for DLTs if the patient received the planned CT0596 dose and either completed the 28 days of DLT evaluation period after CT0596 infusion or experienced a DLT. Enrolled patients who are not evaluable for DLTs during dose escalation may be replaced. Any Patients who are not DLT evaluable will still be followed for safety and efficacy per the SOA.

Conditions

Interventions

Type	Name	Description
DRUG	CAR-T cells Infusion	chimeric antigen receptor T cells

Timeline

Start date: 2024-12-11
Primary completion: 2027-01-03
Completion: 2027-12-31
First posted: 2024-12-05
Last updated: 2024-12-12

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06718270. Inclusion in this directory is not an endorsement.