Anti-BCMA CAR-NK Cell Therapy for the Relapsed or Refractory Multiple Myeloma

Study Purpose

The purpose of this study is to infuse BCMA CAR-NK cells(Umbilical & Cord Blood (CB) Derived CAR-Engineered NK Cells) to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Signed written informed consent; 2. According to the international standard for multiple myeloma,have information on medical examination proving the diagnosis of multiple myeloma. 3. Received at least 2 prior lines of treatment, including proteasome inhibitor and immunomodulator, no efficacy more than PD; disease progression or relapsed after disease remission and refractory or no remission after treated in the last time. 4. Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level veing as defined ;or light chain MM without measurable disease in the serum or the urine;serum immunoglobulin free light chain isease dL and abnormal serum immunoglobulin kappa/lambda free light chain ratio ; 5. ECOG Scores: 0~2(See Annex 3),the estimated survival time was more than 3 months; 6. During the screening period, the clinical laboratory values met the following criteria: Hemoglobins70g/L (did not receive red blood cell transfusion ≤7 days prior to laboratory tests,recombinant human erythropoietin is allowed); Platelet count >50×10^9/L (did not receive blood transfusion ≤7 days prior to laboratory tests); Neutrophil absolute count oietin is (did not receive supportive treatment lowed); Platelet count >50×10^9/L,allowed to use over growth factor support); ALT and AST ≤3×ULN;Total bilirubin ≤2.0× UNL;Creatinine clearance×40mL/min;corrected serum calcium L/minctordL (3.1 mmol/L), or free calcium ion or freedL(L( ommol/L); Prothrombin time and activated partial thromboplastin time ≤1.5×ULN. 7. The urine pregnancy test of female subjects of childbearing age should be negative and not in lactation; 8. Females of childbearing potential and males must use efficient contraception(form signing the ICF to the end of the trial)

Exclusion Criteria:

1. Have received CAR-NK therapy; 2. Have a history of allergy to any component of cell products; 3. Previous history of other malignancy; 4. Any unstable cardiovascular disease happened the informed consent form by themselves or their legal guardian;boratory tests); be infused using the "3 + 3" dos grade), severe arrhythmia that require drug interference, cardiac angioplasty/coronary stent implantation/cardiac bypass surgery ≤6 months prior to enrollment; 5. Have received allogeneic hematopoietic stem cell transplantation in 3 months for the treatment of multiple myeloma; 6. who has suffered from brain injury, consciousness disorder, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease; 7. There were live vaccinations within 4 weeks before admission; 8. Active hepatitis (positive for HBVDNA or HCVRNA), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to those with HIV infection; 9. Oxygen is needed to maintain adequate oxygen saturation; 10. Contraindications for fludarabine or cyclophosphamide treatment. 11. There was uncontrolled active infection;Patients with autoimmune diseases, immunodeficiency or other diseases requiring immunosuppressive (excluding glucocorticoid)therapy; 12. Pregnant or breasting-feeding women; 13. Subjects had a history of alcohol, drug or mental illness; 14. Any other condition that researcher think it is inappropriate for the subject to anticipate the trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05008536
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Xinqiao Hospital of Chongqing
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

xi zhang, PhD/MD
Principal Investigator Affiliation Department of Hematology, Xinqiao Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma, Refractory
Arms & Interventions

Arms

Experimental: Anti-BCMA CAR-NK Cells

After preconditioning with chemotherapy, the Anti-BCMA CAR-NK Cells will be evaluated

Interventions

Biological: - Anti-BCMA CAR-NK Cells

1-3×10^6 /KG, 3-6×10^6 /KG, 0.6-1.2×10^7/KG Treatment follows a lymphodepletion

Drug: - Fludarabine

recommendation: 30mg/m2 (D-5~D-3),determined by tumor burden at baseline.

Drug: - Cytoxan

recommendation: 300-500mg/m2 (D-5~D-3),determined by tumor burden at baseline.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Chongqing, Chongqing, China

Status

Recruiting

Address

Department of Hematology, Xinqiao Hospital

Chongqing, Chongqing, 400037

Site Contact

Xi Zhang, MD/PhD

zhangxxi@sina.com

13808310064 #+86