Anti-BCMA CAR-NK Cell Therapy for the Relapsed or Refractory Multiple Myeloma
Phase I Study to Evaluate the Safety and Effectiveness of Anti-BCMA CAR-NK Therapy in Relapsed or Refractory Multiple Myeloma
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Early Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: xi zhang, PhD/MD
- Phone Number: +86 13808310064
- Email: zhangxxi@sina.com
Study Contact Backup
- Name: Ruihao Huang, MD
- Phone Number: +86 18984398751
- Email: 1169731117@qq.com
Study Locations
-
-
Chongqing
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Chongqing, Chongqing, China, 400037
- Recruiting
- Department of Hematology, Xinqiao Hospital
-
Contact:
- Ruihao Huang, MD
- Phone Number: +86 18984398751
- Email: 1169731117@qq.com
-
Contact:
- Xi Zhang, MD/PhD
- Phone Number: +86 13808310064
- Email: zhangxxi@sina.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed written informed consent;
- According to the international standard for multiple myeloma,have information on medical examination proving the diagnosis of multiple myeloma.
- 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.
- 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 ;
- ECOG Scores: 0~2(See Annex 3),the estimated survival time was more than 3 months;
- 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.
- The urine pregnancy test of female subjects of childbearing age should be negative and not in lactation;
- Females of childbearing potential and males must use efficient contraception(form signing the ICF to the end of the trial)
Exclusion Criteria:
- Have received CAR-NK therapy;
- Have a history of allergy to any component of cell products;
- Previous history of other malignancy;
- 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;
- Have received allogeneic hematopoietic stem cell transplantation in 3 months for the treatment of multiple myeloma;
- who has suffered from brain injury, consciousness disorder, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
- There were live vaccinations within 4 weeks before admission;
- Active hepatitis (positive for HBVDNA or HCVRNA), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to those with HIV infection;
- Oxygen is needed to maintain adequate oxygen saturation;
- Contraindications for fludarabine or cyclophosphamide treatment.
- There was uncontrolled active infection;Patients with autoimmune diseases, immunodeficiency or other diseases requiring immunosuppressive (excluding glucocorticoid)therapy;
- Pregnant or breasting-feeding women;
- Subjects had a history of alcohol, drug or mental illness;
- Any other condition that researcher think it is inappropriate for the subject to anticipate the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Anti-BCMA CAR-NK Cells
After preconditioning with chemotherapy, the Anti-BCMA CAR-NK Cells will be evaluated
|
recommendation: 30mg/m2 (D-5~D-3),determined by tumor burden at baseline.
recommendation: 300-500mg/m2 (D-5~D-3),determined by tumor burden at baseline.
1-3×10^6 /KG, 3-6×10^6 /KG, 0.6-1.2×10^7/KG
Treatment follows a lymphodepletion
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Remission Rate (ORR)
Time Frame: 2 monthes after infusion
|
Response assessment per International Myeloma Working Group (IMWG) criteria
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2 monthes after infusion
|
|
Incidence of dose limiting toxicity (DLTs)
Time Frame: within 2 monthes after infusion
|
To characterize the safety, tolerability of Anti-BCMA CAR-NK Cells
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within 2 monthes after infusion
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free survival (PFS)
Time Frame: up to 24 months
|
Response assessment per International Myeloma Working Group (IMWG) criteria
|
up to 24 months
|
|
Duration of Response (DOR)
Time Frame: up to 24 months
|
Response assessment per International Myeloma Working Group (IMWG) criteria
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up to 24 months
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: xi zhang, PhD/MD, Department of Hematology, Xinqiao Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Fludarabine
Other Study ID Numbers
Other Study ID Numbers
- BCMA NK for MM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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