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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03711864
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : September 30, 2020
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 CAR-T cells 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
Allocation: N/A
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
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : October 10, 2021
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: IM21 CAR-T cells
IM21 CAR-T cells
Biological: IM21 CAR-T cells
fludarabine and cyclophosphamide Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days
Other Name: IM21




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 had multiple myeloma (according to the updated IMWG diagnostic criteria)Active (symptomatic) myeloma
  2. Refractory and recurrent multiple myeloma Refractory definition: 1) treated with at least second-line bortezomib or lenalidomide 2) determined by the clinician Definition of recurrence: refer to NCCN clinical guidelines for multiple myeloma (2016. V2), including recurrence after transplantation.
  3. Age: 18 to 80 years old;
  4. The expected survival time was more than 3 months;
  5. ECoG score 0-2 (refer to Annex 2)
  6. Hemoglobin (HB)≥80g/L; absolute neutrophil count (ANC)>1×10^9/L; platelet count(PLT)≥50×10^9/L.

Those who voluntarily participated in the experiment and signed informed consent.

Exclusion Criteria:

  1. High risk organ involvement patients: tumor invasion of central nervous system, gastrointestinal tract,lung,pericardium,one of the major vessels;
  2. Those who have graft-versus-host reaction and need to use immunosuppressants, or who have autoimmune diseases;
  3. Chemotherapy or radiotherapy was used within 3 days before blood collection;
  4. Patients who used systemic steroids within 5 days before blood collection (except those who have recently or are currently using inhaled steroids);
  5. The patients who used drugs to stimulate the production of bone marrow hematopoietic cells within 5 days before the blood collection period;
  6. Those who have previously used any gene therapy products;
  7. History of epilepsy or other central nervous system diseases;
  8. New York Heart Association (NYHA) grade III or above (refer to Annex 3) (for patients with heart disease, this assessment is required);
  9. Creatinine > 1.5 times normal upper limit, ALT / AST>3 times normal upper limit or bilirubin >2 times normal upper limit;
  10. Active hepatitis B or hepatitis C virus, HIV or other uncured active infections;
  11. Pregnant or lactating women;
  12. Those who suffer from other uncontrolled diseases are not suitable to join the study; Any situation that the researchers believe may increase the risk of subjects or interfere with the test results.

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


Contacts
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Contact: Lu Zhang, M.D. +86-18610728815 pumczhanglu@163.com

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.
Investigators
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Principal Investigator: Daobin Zhou, M.D. Peking Union Medical College Hospital
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Responsible Party: Lu Zhang, Attending doctor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03711864    
Other Study ID Numbers: YMCART201804
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020

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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