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

NCT06718270 | Recruiting Early Phase 1

• 1 other identifier: CT0596-CG6022_01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed/Refractory Multiple Myeloma; Relapsed/Refractory Plasma Cell Leukemia

Keywords

Relapsed/Refractory Multiple Myeloma; Relapsed or Refractory Plasma Cell Leukemia; CAR-T

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

EXPERIMENTAL

chimeric antigen receptor T cells

Drug: CAR-T cells Infusion

Interventions

CAR-T cells Infusion DRUG

chimeric antigen receptor T cells

CAR-T cells Infusion

Eligibility Criteria

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

You may qualify if:

• Participants must meet all of the following criteria to be enrolled:
• 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.
• Patients must have measurable disease based on at least one of the following parameters:
• Expected survival \> 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) score 0- 1 ;
• Patients should meet the following test results
• 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;
• 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);
• 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;
• 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 before informed consent
• 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;
• 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 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;
• Patients with active autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis and other diseases requiring long-term immunosuppressive therapy;

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead
• CARsgen Therapeutics Co., Ltd.: collaborator

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Leukemia, Plasma Cell; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Leukemia; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Du, Ph D

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Du, Ph D

CONTACT

15800706091; juan_du@live.com

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: November 24, 2024
• First Posted: December 5, 2024
• Study Start: December 11, 2024
• Primary Completion (Estimated): January 3, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 12, 2024

Record last verified: 2024-11

Locations

CN (1)