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Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03711864
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
Beijing Immunochina Medical Science & Technology Co., Ltd.
Information provided by (Responsible Party):
Lu Zhang, Peking Union Medical College Hospital

Brief Summary:
In patients with multiple myeloma with recurrent or refractory BCMA, car-t cell infusion was performed after screening, blood collection and pretreatment. Starting dose for 5 x 10 ^ 5 / kg, 1 x 10 ^ 6 doses sequentially. If dose-limiting toxicity is not observed in 3 patients in a dose group, the next dose group test can be performed; If more than 2/3 of patients (2 cases, included) in a dose group had DLT, dose-escalation was not performed. If 1 case of DLT (1/3) appears in the first 3 patients of a dose group, 3 patients need to be added to the dose group (at this time, there are 6 patients in the group).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: IM21 CART Phase 1

Detailed Description:
In patients with multiple myeloma with recurrent or refractory BCMA, car-t cell infusion was performed after screening, blood collection and pretreatment. Starting dose for 5 x 10 ^ 5 / kg, 1 x 10 ^ 6 doses sequentially. If dose-limiting toxicity is not observed in 3 patients in a dose group, the next dose group test can be performed; If more than 2/3 of patients (2 cases, included) in a dose group had DLT, dose-escalation was not performed. If 1 case of DLT (1/3) appears in the first 3 patients of a dose group, 3 patients need to be added to the dose group (at this time, there are 6 patients in the group). If DLT occurs in 1 of the 3 patients (with or without) or 2 of the 6 patients (with or without), no further dose escalation is allowed. Researchers and bidders to form drug safety monitoring committee (SRC), every dose group of subjects to complete the DLT observation period, after summarizing the security of this dose group, determine the test of the next dose, subjects such as draw up the highest dose group safety tolerance, SRC to decide whether to continue to increase the dose group of research, finally according to have obtained all the safety and efficacy of dose group information to determine the recommended dose (RP2D).Dose-limiting toxicity (DLT)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma
Estimated Study Start Date : October 10, 2018
Estimated Primary Completion Date : October 10, 2020
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: IM21 CART
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing BCMA CAR will be infused 24-96 hours later.
Biological: IM21 CART
fludarabine and cyclophosphamide Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days
Other Name: IM 21




Primary Outcome Measures :
  1. Occurrence of study related adverse events [ Time Frame: 2 years ]
    defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) the patient has suffered from multiple myeloma (according to the updated diagnostic criteria of IMWG)Need to meet one or more of the following: • elevated blood calcium (> 11.5 mg/dL) > 2.65 tendency/L, renal insufficiency (creatinine > 2 mg/dL) [177 (including mol/L or higher] or creatinine clearance < 40 ml/min, anemia (hemoglobin < 10 g/dL and hemoglobin below normal floor > 2 g/dL), bone disease (soluble osseous lesions or osteoporosis) in X-ray radiography and CT bone or PET - CT found in more than one place or bone lesionsOr in compliance with any of the following: • bone marrow clonal plasma cells greater than or equal to 60% • abnormal serum free light chain ratio greater than or equal to 100 (involvement) or <0.01 (involvement) • focal lesions of >1 found by functional imaging examination including PET/CT and/or whole-body MRI2) immunohistochemistry or flow cytometry detection of positive BCMA expression in patients with refractory recurrent multiple myeloma;Refractory definition: 1) at least through second-line treatment with bortezomib or lenadamine or 2) clinician determination.Definition of recurrence: see NCCN clinical guidelines for multiple myeloma (2016.v2), including post-transplant recurrence.3) age: 18 to 80 years old;4) the expected survival period is more than 3 months;5) score 0-2 for ECOG (refer to annex 2)6) hemoglobin (Hb) is greater than or equal to 80g/L; Neutrophil count absolutely (ANC) > 1 x 10 ^ 9 / L; The platelet total (PLT) 50 x 10 ^ 9 or higher/L.Volunteer to participate in the test and sign the informed consent

Exclusion Criteria:

  • 1) patients with high-risk viscera involvement: tumor invading central nervous system, gastrointestinal tract, lung, pericardium, one of the large vessels;2) those who have graft versus host reaction and need to use immunosuppressive agents; Or people with autoimmune diseases;3) patients who used chemotherapy or radiotherapy within 3 days before blood sampling;4) a combination of systemic steroid use within 5 days before the blood collection period (except for recent or current use of inhaled steroids);5) use drugs to stimulate the production of bone marrow hematopoietic cells within 5 days before the blood collection period (such as elevating white needle);6) have used any gene therapy products before;7) history of epilepsy or other diseases of the central nervous system;8) New York heart association (NYHA) class for Ⅲ above (see attachment 3);9) the normal upper limit of creatinine >1.5 times or ALT/AST>3 times or bilirubin >2 times;10) active hepatitis b or c, HIV or other uncured active infected persons;11) pregnant or lactating women;12) patients with other uncontrolled diseases, which are deemed inappropriate by researchers;Any condition that may increase the risk of the subject or interfere with the results of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711864


Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100005
Contact: Jian Li, M.D.    +86-18610852525    lijian@pumch.cn   
Contact: Lu Zhang, M.D.    +86-18610728815    pumczhanglu@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Beijing Immunochina Medical Science & Technology Co., Ltd.

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Responsible Party: Lu Zhang, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03711864     History of Changes
Other Study ID Numbers: YMCART201804
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases