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B Cell Maturation Antigen(BMCA)-Targeted CAR-T for Refractory/Relapsed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03931421
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Wenbin Qian, First Affiliated Hospital of Zhejiang University

Tracking Information
First Submitted Date  ICMJE April 25, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date June 4, 2019
Estimated Study Start Date  ICMJE July 31, 2019
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • complete remission rate [ Time Frame: at the time point 3 months after CAR-T cell transfusion ]
    complete remission rate after treated by CAR-T therapy
  • incidence and severity of adverse events [ Time Frame: from the date of the start of treatment to 36 months after last patient's enrollment ]
    any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Original Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • complete remission rate [ Time Frame: at the time point 3 months after CAR-T cell transfusion ]
    complete remission rate after treated by CAR-T therapy
  • adverse events [ Time Frame: from the date of the start of treatment to 36 months after last patient's enrollment ]
    any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • progression free survival [ Time Frame: from the day of treatment to the date of first documented progression,up to 36 months after the last patient's enrollment ]
    from date of inclusion to date of progression, relapse, or death from any cause
  • overall survival [ Time Frame: from the day of treatment to the date of first documented progression,up to 36 months after the last patient's enrollment ]
    from the date of inclusion to date of death, irrespective of cause
  • duration of the CAR-T cells in the patients [ Time Frame: from the date of re-transfusison to 36 months after last patient's enrollment ]
    time from re-transfusion to date when the modified T cells become non-detectable
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 B Cell Maturation Antigen(BMCA)-Targeted CAR-T for Refractory/Relapsed Multiple Myeloma
Official Title  ICMJE B Cell Maturation Antigen(BMCA)-Targeted CAR-T for Refractory/Relapsed Multiple Myeloma
Brief Summary It's a single arm, open label prospective study, in which the safety and efficacy of B Cell Maturation Antigen(BMCA)-targeted CAR-T thearpy are evaluated in refractory/relapsed multiple myeloma patients.
Detailed Description In this trial, T cells are seperated from multiple myeloma patients, and engineered into BMCA-targeted CAR-T cells, these cells are then transfused back into the patients to elimimnate the myeloma cells. In this process, the safety and efficacy of this CAR-T treatment are closely monitored.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
In this trial, T cells were seperated from refractory/relapsed multiple myeloma patients and engineered into BMCA-targeted CAR-T cells, and then transfused back into the patients for the treatment of their multiple myeloma.
Masking: None (Open Label)
Masking Description:
It's an open-label trial.
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Biological: CAR-T treatment
a novel method for treatment of multiple myeloma, in which patients' T cells are engineered into B Cell Maturation Antigen(BMCA)-Targeted CAR-T cells to eliminate myeloma cells.
Study Arms  ICMJE Experimental: experiment group
In this arm, patients are treated with B Cell Maturation Antigen (BMCA)-targeted CAR-T cells and the safety and efficacy will be observed.
Intervention: Biological: CAR-T treatment
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: April 25, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Age≥18,male or female;
  • 2. ECOG 0-3;
  • 3. Clearly diagnosed as multiple myeloma (MM) [according to IMWG 2014 criteria];
  • 4. Patients should have received 3 different regimens prior to enrollment (each regimen should last for at least one complete cycle, except for the case of disease progression);
  • 5. Previously received one PI and IMiD treatment;
  • 6. MM patients should fit one of the following: 1) disease progression; 2) relapsed after CR. The corresponding criteria is defined as follows: a, disease progression should satisfy at least 1 of the following: serum M protein ≥0.5g/dl, or urine M protein>200mg/24h, or FLC increasement >10mg/dl, or bone marrow plasma cell proportion >10%, or with new bone disease/plasmacytoma/original focus increased by 50% or more, or hypercalcemia ( corrected serum calcium level >11.5mg/dL(2.65mmol/L); b. relapse after CR, should satisfy one of the following: ①M protein in urine or blood; ②bone marrow plasma cell proportion≥5%; ③manifestation of disease progression, such as plasmacytoma, osteolytic lesions or hypercalcemia.
  • 7. Peripheral blood mononucleated cell separation should be at least 2 weeks from chemo/radiotherapy;
  • 8. Neutrophil count≥1000/ul, platelet count≥45000/ul, Hb>60g/l;
  • 9. Cardiac, hepatic and renal function: Creatinin <1.5 times of normal maximum;ALT/AST level <2.5 times of the maximum of normal range; total bilirubin<1.5 times of ULN;cardiac ejection fraction≥ 50%; no pericardial effusion within 6 weeks prior to enrollment;
  • 10. Being able to understand and willing to sign the written consent;
  • 11. Fertile patients should agree to take contraceptive measures during the process of this trial.

Exclusion Criteria:

  • 1. History of other tumors other than multiple myeloma, except for the following: malignant tumor after radical surgery, and have been inactive for ≥3 years prior to enrollment; skin cancer (not melanoma) after sufficient treatment, no evidence of disease at enrollment;
  • 2. History of the following treatment: received targeted therapy, epigenetic therapy or clinical trials, invasive operation within 14 days/5 half-time prior to enrollment. History of monoclonal antibody within 21 days prior to enrollment. History of cytotoxic medicine or proteasome treatment within 14 days prior to enrollment. History of immunomodulatory treatment within 7 days prior to enrollment;
  • 3. History of >5mg/d systemic prednisone treatment (or other glucocorticoids of the equivalent dosage) within 2 weeks prior to peripheral mononucleated cell collection;
  • 4. With CNS involvement or clinical manifestation of meningeal myeloma;
  • 5. With active systemic infection;
  • 6. With active HBV infection or HCV infection, or history of type C hepatitis;
  • 7. With immunodeficiency, including HIV infection;
  • 8. With the following heart condition: NYHA level III or IV congestive heart failure; myocardial infarction or CABG within 6 months prior to enrollment; clinically meaningful ventricular arrythmia, or history of idiopathic syncope (not caused by vascular-vagal disorder or dehydration), history of non-ischemic myopathy;
  • 9. With active autoimmune disease;
  • 10. History of autologous stem cell transplantation within 6 weeks prior to enrollment;
  • 11. History of allogenic stem cell transplantation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wenbin Qian, MD,PhD (+86)13605801032 qianwenb@aliyun.com
Contact: Hui Liu, MD,PhD (+86)13819198629
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03931421
Other Study ID Numbers  ICMJE lymphoma center Q004
Has Data Monitoring Committee No
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
Plan to Share IPD: Yes
Plan Description: All the data would be available on the website of the affiliated hospital after the trial is completed
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Wenbin Qian, First Affiliated Hospital of Zhejiang University
Study Sponsor  ICMJE First Affiliated Hospital of Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account First Affiliated Hospital of Zhejiang University
Verification Date June 2019

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