Assess the Safety and Efficacy of CT0594CP Cells in Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia

NCT05893693 | Unknown

• 1 other identifier: CT0594CP-CG6020
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT0594CP CAR-T Cells in patients with relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia

Conditions

Relapsed and/or Refractory Multiple Myeloma; Plasma Cell Leukemia in Relapse

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability dose limiting toxicity

  Safety and tolerability: dose limiting toxicity \[Time Frame: 21-28 days post administration of CT0594CP \]

  21-28 days

Secondary Outcomes (5)

• Pharmacokinetics of CT0594CP CAR-T Cells (Tmax)

  From first dose of study drug adminisration to end of treatment (up to 12 months)

• Pharmacokinetics of CT0594CP CAR-T Cells (Cmax)

  From first dose of study drug adminisration to end of treatment (up to 12 months)

• Pharmacokinetics of CT0594CP CAR-T Cells (AUC)

  From first dose of study drug adminisration to end of treatment (up to 12 months)

• To evaluate the overall safety and tolerability of CT0594CP

  From first dose of study drug administration to end of treatment (up to 12 months)

• To evaluate the initial efficacy of CT0594CP infusion in target subjects

  From first dose of study drug administration to end of treatment (up to 12 months)

Study Arms (1)

CT0594CP CAR-T Cells [BCMA-UCAR-T (CT0594)andCD94-UCAR-T(CT7590) ]

EXPERIMENTAL

CT0594CP

Other: Biological

Interventions

Biological OTHER

CT0594CP

CT0594CP CAR-T Cells [BCMA-UCAR-T (CT0594)andCD94-UCAR-T(CT7590) ]

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients and legally acceptable representative must have voluntarily signed ICF and willing to complete the study procedure, after fully understanding of the study.
• Age ≥ 18 years and ≤ 75 years, male or female.
• The patients, with MM or Plasma Cell Leukemia, who have received regimens and have medical records in the past.
• According to the IMWG consensus for relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia, the disease is in a progressive state
• Subjects should have measurable disease.
• Serum M protein ≥ 5 g / L;
• hour urinary M-protein ≥ 200 mg;
• The serum free light chain (sFLC) ratio was abnormal and the involved FLC ≥ 100mg/L in patients with light chain multiple myeloma whose serum or urinary M protein levels did not meet the assessable criteria.
• Circulating plasma cells ≥2%
• Expected survival \> 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) scores 0-1.
• Subjects should have adequate function in hemostatic and liver and kidney.
• Women of childbearing age must undergo a serum pregnancy test with negative results at screening and before lymphodepletion and be willing to use an effective and reliable method of contraception for at least 1 year after study treatment. All female subjects are prohibited from egg donation within 1 year after study treatment.
• Men must be willing to use an effective and reliable method of contraception for at least 1 year after study treatment if they have sexual activity with women of childbearing potential. All male subjects are prohibited from sperm donation within 1 year after study treatment .

You may not qualify if:

• Pregnant or lactating women.
• Subjects positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema pallidum (syphilis) antibody, CMV（IgM），EBV;
• Active hepatitis B and/or active hepatitis C (HCV RNA positive); Those who are positive for hepatitis B surface antigen and/or core antibodies but whose HBV-DNA test is within normal limits may be enrolled.
• Subjects with any uncontrolled active infection (Except for prophylactic treatment).
• Subjects with AEs from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ 1, excluding hair loss and other events that the treating physician considers as tolerable.
• Subjects who have received autologous BCMA CAR-T therapy
• Subjects who have received allogeneic stem cell transplantation for MM.
• Subjects who have received autologous stem cell transplantation less than 12 weeks before ICF.
• Subjects who have received any anti-MM treatment 14 days before ICF; the subjects are eligible to participate in the study regardless of the radiotherapy end date if the radiation area less than 5% of whole body.
• Subjects who have received systemic glucocorticoids within 7 days before infusion, except inhaled steroids.
• Subjects who have been received live attenuated vaccine within 8 weeks or inactivated vaccine within 4 weeks before lymphodepletion.
• Subjects have severe allergy history.
• Subjects who have any uncontrolled disease conditions within 6 months prior to the screening.
• LVEF \< 50%
• Blood oxygen saturation that can only be maintained at \> 95% by oxygen inhalation.

Sponsors & Collaborators

• Aibin Liang，MD，Ph.D.: lead
• CARsgen Therapeutics Co., Ltd.: collaborator

Study Sites (1)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200333, China

RECRUITING

MeSH Terms

Interventions

Biological Products

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Aibin Liang

  +8618601670600

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aibin Liang

CONTACT

+8618601670600; lab7182@tongji.edu.cn

Ping Li

CONTACT

+86 13564181131; lilyforever76@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of hospital

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: June 8, 2023
• Study Start: April 12, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 8, 2023

Record last verified: 2023-05

Locations

CN (1)