BCMA CAR-NK For Patients With RRMM

Sponsor

Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05747586

Collaborator

Hangzhou Cheetah Cell Therapeutics Co., Ltd (Other)

Enrollment

Locations

Arm

12.9

Anticipated Duration (Months)

4.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma in Relapse Multiple Myeloma, Refractory	Drug: BCMA CAR-NK Drug: Cyclophosphamide Drug: Fludarabine Phosphate	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: rrMM

Drug: BCMA CAR-NK

BCMA CAR-NK infusion

Drug: Cyclophosphamide

Lymphodepleting chemotherapy

Drug: Fludarabine Phosphate

Lymphodepleting chemotherapy

Outcome Measures

Primary Outcome Measures

DLT [28 days]
dose limiting toxicity
MTD [28 days]
maximal tolerable dose

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The age is ≥ 18 years old and the expected survival time is more than 3 months.
According to IMWG standard, it was diagnosed as active MM;
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;
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,
ECOG score 0-2,
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.
The peripheral superficial vein of the patient is unobstructed and can meet the needs of intravenous drip;
There are no other serious diseases in conflict with the programme (such as autoimmune diseases, immunodeficiency, organ transplantation);
No history of other malignant tumors;
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;
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.
The patient agreed to participate in the clinical study and signed the subject's informed consent form.

Exclusion Criteria:

systemic active infection requiring treatment;
immunodeficiency, autoimmune disease;
severe allergic disease;
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;
Severe psychiatric disorders;
Received cellular therapy in the previous 3 months;
Patients with brain metastases from tumors
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
Organ transplant recipients.
Pregnant or lactating women.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first affiliated hospital of medical college of zhejiang university	Hangzhou	Zhejiang	China	310003
2	The first affiliated hospital of medical college of zhejiang university	Hangzhou	Zhejiang	China	310003