Clinical trial NCT04537442: Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma
Official title: Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Multiple myeloma
Lead sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-03
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single center study to assess the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma in China.

Detailed description: In this study, about 10 patients with relapsed or refractory multiple myeloma aged ≥60 years were recruited for IM21 CAR-T cell single transfusion therapy. The safety and tolerability of the treatment were evaluated, and the curative effect was initially observed. The research plan includes five stages: screening stage, cell collection stage, chemotherapy pretreatment stage, infusion stage and follow-up stage.

Eligibility criteria: Inclusion Criteria:

1. Patients with relapsed or refractory multiple myeloma who had received at least second line regular treatment failure;
2. Age ≥60 years old;
3. The expected survival time is more than 3 months;
4. ECOG score is 0-2;
5. Those who voluntarily participate in the study and sign the informed consent;
6. Hemoglobin (Hb)≥80g/L; Absolute count of neutrophils (ANC) \>1×10\^9/L Total platelet count (PLT)≥35×10\^9/L;
7. left ventricular ejection fraction \> 45%.

Exclusion Criteria:

1. High-risk viscera-involved patients: the tumor invaded the gastrointestinal tract, lung, pericardium and one of the great vessels;
2. Those who have graft versus host disease and need to use immunosuppressive agents;
3. Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids);
4. Active hepatitis B or C virus, HIV or other untreated active infected persons;
5. Any circumstance that, in the opinion of the investigator, may increase the risk to the subject or interfere with test results;
6. Patients who use chemotherapy or radiotherapy within 3 days before the blood collection stage.

Primary outcomes:
measure: Incidence of adverse events within 1 month after CAR-T cell infusion
timeFrame: 30days
Secondary outcomes:
measure: Objective Response Rate(ORR) at 90 days
timeFrame: 90days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing hospital
state: Beijing
Study officials:
affiliation: Beijing Hospital
name: Hui Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang T, He T, Ma L, Yang Y, Feng R, Ding Y, Shan Y, Bu B, Qi F, Wu F, Lu XA, Liu H. Clinical Outcomes of BCMA CAR-T Cells in a Multiple Myeloma Patient With Central Nervous System Invasion. Front Oncol. 2022 May 16;12:854448. doi: 10.3389/fonc.2022.854448. eCollection 2022.