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To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R/R MM or PCL

ConditionsMultiple MyelomaPlasma Cell Leukemia
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHrain Biotechnology Co., Ltd.

About this trial

This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human BCMA targeted CAR-NK Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory multiple myeloma or plasma cell leukemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects volunteer to participate in clinical trials, understand and sign the informed consent document, be willing to complete all the trial procedures;

18 years and older, Male and female;

Expected survival > 12 weeks;

Documented evidence of multiple myeloma at diagnosis as defined by IMWG updated criteria (2014), or plasma cell leukemia at diagnosis as defined by Diagnosis and therapeutic criteria of hematologic disease (4th edition);

Disqualifiers

Accompanied by other uncontrolled malignancies;

Subjects with positive Hepatitis B surface antigen(HBsAg) or Hepatitis B core antibody (HBcAb) and hepatitis B virus (HBV) DNA titers higher than the lower limit of the normal range of the investigative site; Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human Immunodeficiency Viral (HIV) antibody positive; syphilis primary screening antibody positive;

Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;

Subjects who are considered unsuitable to participate in this trial by the investigator.

Trial design

Design model

Single group

Treatments tested in this trial

  • Human BCMA targeted CAR-NK cells injection

    Drug

    Allogenic genetically modified anti-BCMA CAR transduced NK cells

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Human BCMA Targeted CAR-NK Cells InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose limited toxicity (DLT)

Safety Indicators

Time frame
28 days post infusion

Secondary outcomes

1

Pharmacokinetics parameters - the highest concentration of human BCMA targeted CAR-NK cells amplified in peripheral blood and bone marrow after infusion

Effectiveness Metrics

Time frame
2 years post infusion
2

Pharmacokinetics parameters - the time to reach the highest concentration of human BCMA targeted CAR-NK cells amplified in peripheral blood and bone marrow after infusion

Effectiveness Metrics

Time frame
2 years post infusion
3

Pharmacokinetics parameters - the 28-day area under the curve of human BCMA targeted CAR-NK cells amplified in peripheral blood and bone marrow after infusion

Effectiveness Metrics

Time frame
2 years post infusion
4

Pharmacodynamics characteristics - the detection values of CRP, IL-6, IL-15, Granzyme B cytokines in peripheral blood

Effectiveness Metrics

Time frame
2 years post infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hrain Biotechnology Co., Ltd.

Lead sponsor

Shanghai Changzheng Hospital

Collaborator

Source ClinicalTrials.gov
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