NCT06045091

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P50-P75 for early_phase_1 multiple-myeloma

Timeline
17mo left

Started Jul 2023

Longer than P75 for early_phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jul 2023Sep 2027

Study Start

First participant enrolled

July 4, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Expected
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2.2 years

First QC Date

September 13, 2023

Last Update Submit

September 13, 2023

Conditions

Multiple MyelomaPlasma Cell Leukemia

Keywords

BCMACAR-NKMultiple MyelomaPlasma Cell LeukemiaRelapsed /Refractory

Outcome Measures

Primary Outcomes (1)

  • Dose limited toxicity (DLT)

    Safety Indicators

    28 days post infusion

Secondary Outcomes (14)

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

    2 years post infusion

  • 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

    2 years post infusion

  • 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

    2 years post infusion

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

    2 years post infusion

  • Pharmacodynamics characteristics - the detection values of monoclonal plasma cell in bone marrow

    2 years post infusion

  • +9 more secondary outcomes

Study Arms (1)

Human BCMA Targeted CAR-NK Cells Injection

EXPERIMENTAL

Two doses on Day 0 and Day 7. 1.5×10\^8 CAR+NK cells/dose, 3.0×10\^8 CAR+NK cells/dose or 6.0×10\^8 CAR+NK cells/dose

Drug: Human BCMA targeted CAR-NK cells injection

Interventions

Human BCMA targeted CAR-NK cells injectionDRUG

Allogenic genetically modified anti-BCMA CAR transduced NK cells

Also known as: BCMA CAR-NK
Human BCMA Targeted CAR-NK Cells Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects volunteer to participate in clinical trials, understand and sign the informed consent document, be willing to complete all the trial procedures;
  • 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);
  • One of the following indicators is satisfied:
  • Serum M protein: IgG M protein ≥5 g/L; or IgA M protein ≥5 g/L; or IgD M protein and IgD \>ULN;
  • Urine M protein ≥200 mg/24h;
  • Affected serum free light chain ≥100 mg/L and Serum free light chain ratio is abnormal;
  • Clonal bone marrow plasma cells ≥10 % for non-secretory myeloma;
  • Patients with relapsed/refractory multiple myeloma or plasma cell leukemia, satisfying:
  • Patients have received at least 3 prior MM or PCL treatment regimens containing at least one proteasome inhibitor and one immunomodulatory;
  • Progress is documented within 60 days of the most recent anti-tumor treatment, or efficacy assessment does not reach minimal response(MR) or above;
  • Liver, kidney and cardiopulmonary functions meet the following requirements:
  • Creatinine clearance rate (estimated by CockcroftGault formula) ≥30mL/min;
  • Left ventricular ejection fraction \> 50%;
  • +3 more criteria

You may not qualify if:

  • 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.
  • Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
  • Received CAR-NK treatment or other gene therapies before enrollment;
  • Subjects who have a disease that affects the signing of written informed consent or who are unable to comply with research procedures; or who are unwilling or unable to comply with research requirements;
  • Subjects who have had severe immediate hypersensitivity reactions to any drugs used in this research;
  • Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
  • In the past two years, the terminal organ was damaged due to autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the systemic use of immunosuppressive or other systemic disease control drugs was required;
  • Patients with symptoms of central nervous system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

MeSH Terms

Conditions

Multiple MyelomaLeukemia, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLeukemia

Study Officials

  • Juan Du, Doctor

    Shanghai Changzheng Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuedong Sun, Doctor

CONTACT

+8615811287219sunxuedong@dashengbio.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

July 4, 2023

Primary Completion

September 30, 2025

Study Completion (Estimated)

September 30, 2027

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)