A Study of CT0596 in Plasma Cell Leukemia
ConditionPlasma Cell Leukemia
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
This study is a single-arm, open-label, exploratory dose-escalation and dosefinding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with PCL.
Eligibility criteria
Qualifiers
Patients must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the trial visit schedule and other protocol requirements and agree to be in long term follow-up (LTFU) for up to 15 years as mandated by the regulatory guidelines.
Age ≥ 18 years;
PCL after inductive treatment or R/R pPCL.
Patients must have measurable disease。
Disqualifiers
Pregnant or lactating women;
Patients seropositive for HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection. History of treated hepatitis B or C is permitted if the viral load is undetectable per qPCR and or nucleic acid testing;
Patients with any uncontrolled active infection, including but not limited to patients with active tuberculosis (investigator 's judgment);
Toxicities caused by previous treatment have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1, except alopecia and other events that are judged tolerable by the investigator;
Trial design
Treatments tested in this trial
- CAR-T cells Infusion chimeric antigen receptor T cells
Treatment groups
27 Participants
are divided into 1 treatment groupSponsors and collaborators
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
CARsgen Therapeutics Co., Ltd.
Collaborator
Source ClinicalTrials.gov