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

ConditionsRelapsed/Refractory Multiple Myeloma Relapsed/Refractory Plasma Cell Leukemia

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorShanghai Changzheng Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

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;

Patients with R/RMM who have received at least 3 prior lines of therapy, including at least 1 proteasome inhibitor and at least 1 immunomodulator (IMiD). Patients with RRpPCL had received at least 1 prior line of therapy. Number of lines of therapy was defined according to the guidelines provided in Rajkuma[1]r 2015 . Patients must have received at least 1 complete cycle of therapy for each line of therapy.

According to multiple myeloma IMWG 2016 and plasma cell leukemia IMWG 2013, patients must have progressive disease following or during the last treatment.

Disqualifiers

Pregnant or lactating women;

Patient has any significant condition(s), laboratory abnormality or psychiatric illness that would impair the ability of the patient to receive or tolerate the planned treatment or in the opinion of the investigator, participation would not be in the best interest of the patient (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

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);

Trial design

Design model

Single group

Treatments tested in this trial

CAR-T cells Infusion
Drug
chimeric antigen receptor T cells

Treatment groups

24 Participants

are divided into 1 treatment group

Group A: CAR-T cells InfusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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