Multiple Myeloma, RefractoryEarly Phase 1NCT05008536
Anti-BCMA CAR-NK Cell Therapy for the Relapsed or Refractory Multiple Myeloma
A Early Phase 1 study testing Anti-BCMA CAR-NK Cells, Fludarabine and Cytoxan in people with Multiple Myeloma, Refractory, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma, Refractory
- What is being tested?
- Anti-BCMA CAR-NK Cells, Fludarabine and Cytoxan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Sep 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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）
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hematology, Xinqiao Hospital
Chongqing, Chongqing Municipality, 400037
Xi Zhang, MD/PhD, 13808310064 ext. +86, zhangxxi@sina.com
Ruihao Huang, MD, 18984398751 ext. +86, 1169731117@qq.com
About this study
Official title: Phase I Study to Evaluate the Safety and Effectiveness of Anti-BCMA CAR-NK Therapy in Relapsed or Refractory Multiple Myeloma
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.
- Conditions
- Multiple Myeloma, Refractory
- Being tested
- Anti-BCMA CAR-NK Cells, Fludarabine, Cytoxan
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-BCMA CAR-NK CellsBiological
1-3×10^6 /KG, 3-6×10^6 /KG, 0.6-1.2×10^7/KG Treatment follows a lymphodepletion
FludarabineDrug
recommendation: 30mg/m2 (D-5~D-3),determined by tumor burden at baseline.
CytoxanDrug
recommendation: 300-500mg/m2 (D-5~D-3),determined by tumor burden at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Anti-BCMA CAR-NK Cells | Experimental | After preconditioning with chemotherapy, the Anti-BCMA CAR-NK Cells will be evaluated Receives: Biological: Anti-BCMA CAR-NK Cells; Drug: Fludarabine; Drug: Cytoxan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Remission Rate (ORR)
Response assessment per International Myeloma Working Group (IMWG) criteria
Measured: 2 monthes after infusion
Incidence of dose limiting toxicity (DLTs)
To characterize the safety, tolerability of Anti-BCMA CAR-NK Cells
Measured: within 2 monthes after infusion
Secondary outcomes (2)
Progression-free survival (PFS)
Response assessment per International Myeloma Working Group (IMWG) criteria
Measured: up to 24 months
Duration of Response (DOR)
Response assessment per International Myeloma Working Group (IMWG) criteria
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 Oct 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma, RefractoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Anti-BCMA CAR-NK Cells
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Xi Zhang, MD, Xinqiao Hospital of Chongqing
- Investigators
- xi zhang, PhD/MD, Principal investigator, Department of Hematology, Xinqiao Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008536
- Sponsor's protocol ID
- BCMA NK for MM
- Status last verified
- Nov 2021
- First submitted
- 14 Aug 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluate the Safety and Effectiveness of Anti-BCMA CAR-NK Therapy in Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05008536
- Acronym / sponsor ID
- BCMA NK for MM
- Conditions
- Multiple Myeloma, Refractory
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Anti-BCMA CAR-NK Cells
| Arm | Type | Receives |
|---|---|---|
| Anti-BCMA CAR-NK Cells | Experimental | Biological: Anti-BCMA CAR-NK Cells, Drug: Fludarabine, Drug: CytoxanAfter preconditioning with chemotherapy, the Anti-BCMA CAR-NK Cells will be evaluated |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-BCMA CAR-NK Cells1-3×10^6 /KG, 3-6×10^6 /KG, 0.6-1.2×10^7/KG Treatment follows a lymphodepletion | Biological | Anti-BCMA CAR-NK Cells |
| Fludarabinerecommendation: 30mg/m2 (D-5~D-3),determined by tumor burden at baseline. | Drug | Anti-BCMA CAR-NK Cells |
| Cytoxanrecommendation: 300-500mg/m2 (D-5~D-3),determined by tumor burden at baseline. | Drug | Anti-BCMA CAR-NK Cells |
Primary outcome
Overall Remission Rate (ORR)
Time frame: 2 monthes after infusion
Response assessment per International Myeloma Working Group (IMWG) criteria
Incidence of dose limiting toxicity (DLTs)
Time frame: within 2 monthes after infusion
To characterize the safety, tolerability of Anti-BCMA CAR-NK Cells
2 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 24 months
Duration of Response (DOR)
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xi zhang, PhD/MD principal investigator
Department of Hematology, Xinqiao Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Anti-BCMA CAR-NK Cells, Fludarabine and Cytoxan in people with Multiple Myeloma, Refractory, run by Xinqiao Hospital of Chongqing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xi zhang, PhD/MD (13808310064 ext. +86, zhangxxi@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Remission Rate (ORR) (time frame: 2 monthes after infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.