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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CAR-T cells Infusion chimeric antigen receptor T cells
DrugCAR-T cells Infusion
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: CAR-T cells Infusion chimeric antigen receptor T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Events (AE) after CT0596 infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
Time frame
12 months after CT0596 infusion2
MTD and/or dose range
Evaluate Dose limited toxicity and recommended dosage range after CT0596 infusion
Time frame
12 months after CT0596 infusionSecondary outcomes
1
Overall response rate (ORR) as assessed by the investigator
Overall response rate (ORR) defined as proportion of patients achieving partial response or better based on International Myeloma Working Group defined response criteria
Time frame
12 months after CT0596 infusion2
Complete response/stringent complete response (CR/sCR) rate
Rate of complete response/stringent complete response (CR/sCR) defined as proportion of patients achieving CR or better based on IMWG defined response criteria.
Time frame
12 months after CT0596 infusion3
Rate of very good partial response (VGPR) and above
Rate of complete very good partial response response/stringent complete response (VGPR/CR/sCR) defined as proportion of patients achieving VGPR or better based on IMWG defined response criteria
Time frame
12 months after CT0596 infusion4
Duration of response (DOR)
DOR is defined as the time from first achieving PR or better to confirmed disease progression or death from any cause
Time frame
12 months after CT0596 infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
CARsgen Therapeutics Co., Ltd.
Collaborator
Source ClinicalTrials.gov