A Study of CT0596 in Plasma Cell Leukemia

NCT06988059 | Recruiting Early Phase 1

• 1 other identifier: IIT2025050
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plasma Cell Leukemia

Keywords

Plasma Cell Leukemia; CAR-T cells

Outcome Measures

Primary Outcomes (2)

• Adverse Events (AE) after CT0596 infusion

  An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria

  12 months after CT0596 infusion

• MTD and/or dose range

  Evaluate Dose limited toxicity and recommended dosage range after CT0596 infusion

  12 months after CT0596 infusion

Secondary Outcomes (12)

• Overall response rate (ORR) as assessed by the investigator

  12 months after CT0596 infusion

• Complete response/stringent complete response (CR/sCR) rate

  12 months after CT0596 infusion

• Rate of very good partial response (VGPR) and above

  12 months after CT0596 infusion

• Duration of response (DOR)

  12 months after CT0596 infusion

• Minimal residual disease (MRD) negative rate

  12 months after CT0596 infusion

Study Arms (1)

CAR-T cells Infusion chimeric antigen receptor T cells

EXPERIMENTAL

Drug: CAR-T cells Infusion chimeric antigen receptor T cells

Interventions

CAR-T cells Infusion chimeric antigen receptor T cells DRUG

CAR-T cells Infusion

CAR-T cells Infusion chimeric antigen receptor T cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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。
• Expected survival \> 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) score 0- 1 ;
• Patients should have good organ function。
• Female patients of childbearing potential must have a negative pregnancy test at screening and prior to receiving lymphodepletion therapy and are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating eggs for 1 year after receiving study treatment infusion during the study ;Male patients are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment if they are sexually active with a female of childbearing potential. Sperm donation is absolutely prohibited within 1 year following study treatment infusion for all male patients during the study.

You may not qualify if:

• 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;
• 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
• Previous allogeneic stem cell transplantation; autologous stem cell transplantation within 12 weeks prior to signing informed consent;
• Have received treatment for the disease within 14 days or five half-lives before preconditioning
• Have received cell therapy within 28 days before informed consent.
• Systemic glucocorticoids equivalent to \> 15 mg/day prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids;
• Vaccination with live attenuated vaccines , inactivated vaccines or RNA vaccines within 4 weeks prior to informed consent;
• Major surgery within 2 weeks before informed consent or planned during the study period or within 4 weeks after giving study treatment (excluding local anesthesia such as cataract);
• Allergic or intolerant to lymphodepletion, tocilizumab, or allergic to components (DMSO) in CT0596 CART cell infusion preparation; or previous history of other serious allergies such as anaphylactic shock;
• Patients with secondary plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis at screening;
• Patients with any of the following cardiac conditions within 6 months prior to screening:
• Patients who require supplemental oxygen to maintain oxygen saturation \> 92%; or Patients with known or suspected COPD who have Forced Expiratory Volume in 1 second (FEV1) \< 50% of predicted normal on spirometry;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• CARsgen Therapeutics Co., Ltd.: collaborator

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Plasma Cell

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 23, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): January 3, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)