BCMA CAR-NK For Patients With RRMM

February 17, 2023 updated by: He Huang, Zhejiang University

BCMA CAR-NK(Natural Killer) Cell Therapy For Patients With Replased and/or Refractory Multiple Myeloma

This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of BCMA CAR-NK cells in the treatment of relapsed or/and refractory MM. The primary endpoints are dose limiting toxicity (DLT) and Maximal tolerability evaluation (MTD).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The first affiliated hospital of medical college of zhejiang university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The age is ≥ 18 years old and the expected survival time is more than 3 months.
  2. According to IMWG standard, it was diagnosed as active MM;
  3. Previously received at least 2-line regimen for multiple myeloma, each line has at least one standard treatment cycle, including at least one proteasome inhibitor and one immunomodulator;
  4. Measurable MM disease was defined as serum IgG,A,MM protein ≥ 0.5g/dL or IgDM protein ≥ 0.5g/dL or urine M protein ≥ 200mg/24 hours,
  5. ECOG score 0-2,
  6. Sufficient hematopoietic function and sufficient liver function: a. Neutrophil count ≥ 1.5 × 10E9. White blood cell count ≥ 3 × 10 E 9 hand Lternc. Platelet count ≥ 80 × 10 E 9 hand Lternd. Hemoglobin ≥ 90g. Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN, if there is Gilbert syndrome), f.AST ≤ 2.5 × ULN and ALT ≤ 2.5 × ULN.
  7. The peripheral superficial vein of the patient is unobstructed and can meet the needs of intravenous drip;
  8. There are no other serious diseases in conflict with the programme (such as autoimmune diseases, immunodeficiency, organ transplantation);
  9. No history of other malignant tumors;
  10. Women of childbearing age must be tested negative for blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during and within 3 months after the study;
  11. The results of serological tests for HIV, HBV, HCV and syphilis were negative, and if one item was positive, etiological DNA or RNA test should be added, and the result should be lower than the sensitivity of detection.
  12. The patient agreed to participate in the clinical study and signed the subject's informed consent form.

Exclusion Criteria:

  1. systemic active infection requiring treatment;
  2. immunodeficiency, autoimmune disease;
  3. severe allergic disease;
  4. poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg) or clinically significant (e.g., active) cardiovascular disease, such as cerebrovascular accident (within 6 months prior to signing informed consent), myocardial infarction ( within 6 months prior to signing informed consent), unstable angina, congestive heart failure, or severe arrhythmias that cannot be controlled medically or have potential impact on study treatment;
  5. Severe psychiatric disorders;
  6. Received cellular therapy in the previous 3 months;
  7. Patients with brain metastases from tumors
  8. Known history of human immunodeficiency virus (HIV) infection; positive syphilis antibodies; active hepatitis B and Hepatitis C. Test results meeting one of the following conditions should not be enrolled: confirmed HIV antibody positive; serum HBsAg positive and HBVDNA >200IU/ml or >1000 copies/mL; serum HBsAg negative but if HBcAb (antibody) result is positive and HBVDNA >200IU/mL or 1000 copies/mL; serum HCV antibody
  9. Organ transplant recipients.
  10. Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rrMM
Drug: Cyclophosphamide
Lymphodepleting chemotherapy
Drug: BCMA CAR-NK
BCMA CAR-NK infusion
Drug: Fludarabine Phosphate
Lymphodepleting chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLT
Time Frame: 28 days
dose limiting toxicity
28 days
MTD
Time Frame: 28 days
maximal tolerable dose
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Collaborators

Hangzhou Cheetah Cell Therapeutics Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

February 17, 2023

First Posted (Estimate)

February 28, 2023

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2023]TXB--002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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