BCMA CAR-NK For Patients With RRMM

Multiple Myeloma in Relapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05747586
• Other study ID #: [2023]TXB--002
• Status: Recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: March 2024

Study information

• Verified date: February 2023
• Source: Zhejiang University
• Contact: Hu YongXian
• Phone: +86057187236476
• Email: huyongxian2000[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Multiple Myeloma, Refractory
• Neoplasms, Plasma Cell

Intervention

Drug:
• BCMA CAR-NK
BCMA CAR-NK infusion
• Cyclophosphamide
Lymphodepleting chemotherapy
• Fludarabine Phosphate
Lymphodepleting chemotherapy

Locations

Country	Name	City	State
China	The first affiliated hospital of medical college of zhejiang university	Hangzhou	Zhejiang
China	The first affiliated hospital of medical college of zhejiang university	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang University	Hangzhou Cheetah Cell Therapeutics Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT	dose limiting toxicity	28 days
Primary	MTD	maximal tolerable dose	28 days