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Multicenter Clinical Study on the Safety and Effectiveness of CAR-T in the Treatment of Relapsed/Refractory Plasma Cell Tumors

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ClinicalTrials.gov Identifier: NCT04665076
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : December 11, 2020
Sponsor:
Collaborator:
Hebei Medical University Fourth Hospital
Information provided by (Responsible Party):
Hebei Senlang Biotechnology Inc., Ltd.

Tracking Information
First Submitted Date  ICMJE December 7, 2020
First Posted Date  ICMJE December 11, 2020
Last Update Posted Date December 11, 2020
Actual Study Start Date  ICMJE October 22, 2020
Estimated Primary Completion Date October 21, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • Safety: Incidence and severity of adverse events [ Time Frame: first one month after CAR-T infusion ]
    To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
  • Efficacy: Remission Rate [ Time Frame: 3 months post CAR-T cells infusion ]
    Remission Rate including complete remission (CR), partial remission (PR), objective response (ORR = CR + PR), disease stability (SD), disease progression (PD) and unresponsive (NR)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • Efficacy:duration of response (DOR) [ Time Frame: 24 months after CAR-T infusion ]
    duration of response (DOR)
  • Efficacy: progression-free survival (PFS) [ Time Frame: 24 months after CAR-T infusion ]
    progression-free survival (PFS) time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicenter Clinical Study on the Safety and Effectiveness of CAR-T in the Treatment of Relapsed/Refractory Plasma Cell Tumors
Official Title  ICMJE Multicenter Clinical Study on the Safety and Effectiveness of CAR-T in the Treatment of Relapsed/Refractory Plasma Cell Tumors
Brief Summary This study is a multi-center, non-randomized, single-arm, open clinical trial.
Detailed Description A single car consists of scFv, hinge region, transmembrane region, costimulatory domain and zeta subunit of CD3.Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Plasma Cell Tumors
Intervention  ICMJE
  • Biological: Auto CAR-T
    Biological: Auto CAR-T
  • Drug: Cyclophosphamide,Fludarabine
    Drug: Cyclophosphamide,Fludarabine
  • Procedure: Leukapheresis
    Leukapheresis
Study Arms  ICMJE Experimental: Auto CAR-T
Patients will be treated with Auto CAR-T cells
Interventions:
  • Biological: Auto CAR-T
  • Drug: Cyclophosphamide,Fludarabine
  • Procedure: Leukapheresis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 21, 2025
Estimated Primary Completion Date October 21, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the visits, treatment plans, laboratory inspections, and other requirements of the research as specified in the test procedure;
  2. Patients with relapsed/refractory plasma cell tumors determined by clinical diagnosis;

    The definition of relapsed/refractory plasma cell tumors is:

    1. Primary resistance to standard treatment regimens;
    2. Or PD occurs after standard treatment with at least second-line standard treatment plan;
    3. Or the last treatment effect is SD and the duration does not exceed 6 months;
    4. Or treatment with proteasome inhibitors and immunomodulators is ineffective or relapses;
    5. Patients who have PD after autologous hematopoietic stem cell transplantation or confirmed recurrence by biopsy within 12 months, or patients who undergo salvage treatment after autologous hematopoietic stem cell transplantation have no remission or relapse after treatment.
  3. According to RECIST version 1.1 , there should be at least one measurable tumor (soft tissue mass) or serum M protein ≥10g/L or urine M protein ≥200mg/24h;
  4. Subjects whose physical status scored by the Eastern Cooperative Oncology Group (ECOG) is 0~2;
  5. 14 years old ≤ age ≤ 75 years old, both male and female;
  6. Immunohistochemistry or flow cytometry detects tumor cells as BCMA or CD19/CD22/CD79 positive;
  7. The estimated survival period from the date of signing the informed consent form is greater than 3 months;
  8. Laboratory examinations meet the following conditions: hemoglobin ≥80g/L, platelet count ≥50 × 109/L, absolute neutrophil count (ANC) ≥1.0 × 109/L, if the investigator believes that the above inspection value is below the lower limit It is caused by tumor invading bone marrow and can be included in the group after consultation with the sponsor;
  9. The main organ function indicators meet the following conditions: AST (aspartate aminotransferase)/ALT (alanine aminotransferase)/ALP (alkaline phosphatase) ≤2.5 ULN, serum creatinine ≤1.5 ULN, total bilirubin ≤1.5 ULN, left Ventricular ejection fraction (LVEF) ≥50%, and minimum pulmonary function reserve (dyspnea is not higher than grade 1 and blood oxygen saturation> 92% under indoor conditions).

Exclusion Criteria:

  1. Severe cardiac insufficiency, left ventricular ejection fraction <50%;
  2. There is a history of severe lung dysfunction diseases;
  3. The patient has had other malignant tumors in the past 5 years, except for skin basal cell carcinoma, breast carcinoma in situ and cervical carcinoma in situ that have undergone radical treatment;
  4. Combined with severe or persistent infection and cannot be effectively controlled; Severe infection: Refers to sepsis or uncontrolled infection of the infected foci, and can be included in the group after infection is controlled
  5. Combined metabolic diseases (except diabetes);
  6. Combined with severe autoimmune disease or innate immune deficiency;
  7. Untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] test results are positive, HBV-DNA ≥ 500 IU/ml and abnormal liver function; hepatitis C, defined as hepatitis C antibody [ HCV-Ab] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined with hepatitis B and C co-infection;
  8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
  9. A history of severe allergies to biological products (including antibiotics);
  10. Participate in any other clinical drug trials at the same time within one month;
  11. There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the research, or interfere with the results of the research, and patients who the researcher believes are not suitable for participating in this research.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jianqiang Li, PhD & MD 008615511369555 limmune@gmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04665076
Other Study ID Numbers  ICMJE 2020104
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hebei Senlang Biotechnology Inc., Ltd.
Study Sponsor  ICMJE Hebei Senlang Biotechnology Inc., Ltd.
Collaborators  ICMJE Hebei Medical University Fourth Hospital
Investigators  ICMJE
Principal Investigator: Baoen Shan, PhD & MD Hebei Medical University Fourth Hospital
Principal Investigator: Lihong Liu, PhD & MD Hebei Medical University Fourth Hospital
PRS Account Hebei Senlang Biotechnology Inc., Ltd.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP