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).
Title
- Brief Title: Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma
- Official Title: Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma
Clinical Trial IDs
- ORG STUDY ID:
YMCART201804
- NCT ID:
NCT03711864
Conditions
Interventions
Drug | Synonyms | Arms |
---|
IM21 CART | IM 21 | IM21 CART |
Purpose
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).
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)
Trial Arms
Name | Type | Description | Interventions |
---|
IM21 CART | Experimental | 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. | |
Eligibility 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.
Maximum Eligible Age: | 80 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Occurrence of study related adverse events |
Time Frame: | 2 years |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Peking Union Medical College Hospital |
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