Multiple MyelomaNCT06594211
Allogeneic Anti-BCMA/GPRC5D Bispecific CAR-NK Cells (ACT-001) in Patients With Relapsed or Refractorymultiple Myeloma
A study testing ACT-001 CAR-NK cell in people with Multiple Myeloma, run by RenJi Hospital at 1 site in China.
Trial summary
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and efficacy of allogeneic anti-BCMA/GPRC5D bispecific chimeric antigen receptor natural killer (CAR-NK) cells (ACT-001) in patients with refractory or relapsed multiple myeloma (r/r MM). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- ACT-001 CAR-NK cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2024to 9 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 75 years inclusive, with no gender restrictions.
- Expected survival time exceeding 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Documented diagnosis of relapsed or refractory multiple myeloma (RRMM), and meets the following conditions:
- Relapsed or refractory after at least three prior lines of therapy, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies, with at least one complete cycle of treatment for each line, unless progressive disease (PD) was documented as the best response to that line.
- Disease progression during the most recent treatment or within 12 months.
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- Measurable disease at screening as defined by at least one of the following:
- Serum M protein ≥ 5 g/L.
- Urine M protein ≥ 200 mg/24h.
- Involved serum free light chain ≥ 100 mg/L and abnormal serum free light chain κ/λ ratio.
- Oxygen saturation ≥ 95% within 3 days prior to cell infusion.
- Clinical laboratory values meeting the following criteria at screening:
- Hemoglobin ≥ 80 g/L (without red blood cell transfusion within 7 days prior to testing; use of recombinant human erythropoietin is allowed).
- Platelet count ≥ 50 × 10^9/L (without platelet transfusion or treatment with recombinant human thrombopoietin or thrombopoietin receptor agonists within 7 days prior to testing).
- Absolute neutrophil count (ANC) ≥ 0.75 × 10^9/L (use of growth factors is allowed, but not within 7 days prior to testing).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN).
- Creatinine clearance ≥ 40 mL/min, calculated based on the Cockcroft-Gault formula.
- Total bilirubin ≤ 2.0 × ULN; for participants with congenital bilirubin encephalopathy (such as Gilbert's syndrome), direct bilirubin must be ≤ 1.5 × ULN.
- Corrected serum calcium ≤ 12.5 mg/dL (≤ 3.1 mmol/L) or ionized calcium ≤ 6.5 mg/dL (≤ 1.6 mmol/L).
- For participants who meet the inclusion criteria at screening, red blood cell transfusion may be performed as needed after screening to maintain hemoglobin levels ≥ 80 g/L.
- Deemed by the investigator to be able to receive lymphocyte-depleting chemotherapy.
- Male participants and females of childbearing potential must agree to use effective contraception from the time of signing the Informed Consent Form (ICF) until 2 years after receiving the study drug. Females of childbearing potential must have a negative serum pregnancy test prior to receiving the study drug.
- The participant can understand the study and has signed the ICF.
- Participants who have previously received BCMA or GPRC5D targeted therapy, including but not limited to CAR-T, antibody-drug conjugates (ADCs), or bispecific antibodies, are allowed to participate in the study.
Who cannot join
- Pregnant or breastfeeding women; and subjects planning pregnancy within 2 years after signing the Informed Consent Form (ICF) until after receiving the study medication.
- Presence of uncontrollable active infections requiring parenteral antibacterials, antivirals, or antifungals; positivity for Hepatitis B surface antigen (HbsAg) or Hepatitis B core antibody (HbcAb), with detectable Hepatitis B Virus (HBV) DNA in peripheral blood; positivity for Hepatitis C Virus (HCV) antibody and HCV RNA in peripheral blood; positivity for TRUST test for syphilis; positivity for Human Immunodeficiency Virus (HIV) antibody.
- Subjects deemed by the investigator to have significant dysfunction of vital organs (cardiovascular, pulmonary); subjects with gastrointestinal active bleeding within 3 months prior to signing the ICF; uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 95 mmHg), hypertensive crisis, or history of hypertensive encephalopathy; history or evidence of significant cardiovascular or cerebrovascular risk, including congestive heart failure (New York Heart Association class ≥ III), left ventricular ejection fraction < 50%, unstable angina, clinically significant arrhythmias (such as ventricular fibrillation, ventricular tachycardia, etc.); history of arterial thrombosis (such as stroke, transient ischemic attack) within 3 months prior to signing the ICF; history of symptomatic deep vein thrombosis, pulmonary embolism within 6 months prior to signing the ICF, or history of coronary artery angioplasty, defibrillation, or any clinical complications or diseases that may pose risks to the subject's safety or interfere with the study evaluation, procedures, or completion.
- History or current evidence of any condition or disease that could interfere with the study results or, in the opinion of the investigator, is not in the best interest of the patient to participate.
- Active central nervous system disease, or a history of the central nervous system requiring treatment (such as epilepsy); or subjects with central nervous system metastatic disease, leptomeningeal disease, or metastatic spinal cord compression.
- Systemic corticosteroid therapy within 1 week prior to treatment, excluding the following: intranasal, inhaled, or local corticosteroids, local corticosteroid injections (such as intra-articular injections), systemic corticosteroid therapy at a daily dose not exceeding 10 mg of prednisone or its equivalent physiological dose, and corticosteroids used as premedication for allergic reactions.
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- Prior antitumor therapy as follows, within the specified time frames prior to cell infusion: (a) Targeted therapy, proteasome inhibitors, or cytotoxic therapy within 2 weeks; (b) Immunomodulatory agent therapy within 1 week; (c) Monoclonal antibody treatment for multiple myeloma within 3 weeks; (d) Radiotherapy within 2 weeks. However, subjects are eligible irrespective of the end date of radiotherapy if the radiation field covered ≤ 5% of the bone marrow reserve.
- Prior therapy with any other investigational drugs or systemic anticancer treatments within 4 weeks prior to signing the ICF.
- History of another primary malignancy within 3 years prior to starting the study treatment, with exceptions for the disease under study, adequately treated basal or squamous cell carcinoma of the skin, and in situ cervical cancer.
- Subjects with a history or presence of interstitial lung disease or interstitial pneumonia.
- Subjects planning to undergo autologous stem cell transplantation (ASCT) during the study.
- Known hypersensitivity to any component of the anti-human BCMA×GPRC5D CAR-NK cell injection or the lymphodepletion regimen (cyclophosphamide and fludarabine).
- Subjects who have undergone major surgery within 2 weeks or received live attenuated vaccines within 4 weeks prior to the pretreatment regimen.
- Any investigator-assessed complications or other conditions that may affect a subject's ability to comply with the protocol or make them unsuitable to participate in the study.
- Subjects with mental disorder who are unable to provide written ICF or comply with study procedures; or those unwilling or unable to adhere to study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Honghui Huang, MD, huanghonghui@renji.com
Jian Hou, MD
About this study
Official title: A Single-Arm, Open-Label Study of Allogeneic Anti-BCMA/GPRC5D Bispecific CAR-NK Cells (ACT-001) in Patients With Relapsed or Refractory Multiple Myeloma
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and efficacy of allogeneic anti-BCMA/GPRC5D bispecific chimeric antigen receptor natural killer (CAR-NK) cells (ACT-001) in patients with refractory or relapsed multiple myeloma (r/r MM).
- Conditions
- Multiple Myeloma
- Being tested
- ACT-001 CAR-NK cell
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-001 CAR-NK cellBiological
Subjects were distributed into three dosage groups, each receiving a single dose of CAR-NK cells at levels of 1×10^8, 3×10^8, and 9×10^8 cells, respectively.
| Study group | Role | What they receive |
|---|---|---|
| ACT-001 CAR-NK cell | Experimental | Not described Receives: Biological: ACT-001 CAR-NK cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: From admission to 28 days after CAR-NK cells infusion
Incidence and type of adverse events (AEs)
To identify the incidence and the type of AEs, including abnormalities in clinical, laboratory assessments, ECGs, echocardiography, vital sign assessments, and physical exams.
Measured: From admission to 2 years after CAR-NK cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Oct 2024 (estimated)
- Primary completion9 Oct 2028 (estimated)
- Study completion9 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Acellytron Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594211
- Sponsor's protocol ID
- LYC2024-007
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label Study of Allogeneic Anti-BCMA/GPRC5D Bispecific CAR-NK Cells (ACT-001) in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06594211
- Acronym / sponsor ID
- LYC2024-007
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Acellytron Therapeutics
- Study start
- 9 Oct 2024 (estimated)
- Primary completion
- 9 Oct 2028 (estimated)
- Study completion
- 9 Oct 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and efficacy of allogeneic anti-BCMA/GPRC5D bispecific chimeric antigen receptor natural killer (CAR-NK) cells (ACT-001) in patients with refractory or relapsed multiple myeloma (r/r MM).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACT-001 CAR-NK cell | Experimental | Biological: ACT-001 CAR-NK cell |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age between 18 to 75 years inclusive, with no gender restrictions.
- Expected survival time exceeding 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Documented diagnosis of relapsed or refractory multiple myeloma (RRMM), and meets the following conditions:
- Measurable disease at screening as defined by at least one of the following:
Key exclusion criteria (15 listed)
- Pregnant or breastfeeding women; and subjects planning pregnancy within 2 years after signing the Informed Consent Form (ICF) until after receiving the study medication.
- Presence of uncontrollable active infections requiring parenteral antibacterials, antivirals, or antifungals; positivity for Hepatitis B surface antigen (HbsAg) or Hepatitis B core antibody (HbcAb), with detectable Hepatitis B Virus (HBV) DNA in peripheral blood; positivity for Hepatitis C Virus (HCV) antibody and HCV RNA in peripheral blood; positivity for TRUST test for syphilis; positivity for Human Immunodeficiency Virus (HIV) antibody.
- Subjects deemed by the investigator to have significant dysfunction of vital organs (cardiovascular, pulmonary); subjects with gastrointestinal active bleeding within 3 months prior to signing the ICF; uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 95 mmHg), hypertensive crisis, or history of hypertensive encephalopathy; history or evidence of significant cardiovascular or cerebrovascular risk, including congestive heart failure (New York Heart Association class ≥ III), left ventricular ejection fraction < 50%, unstable angina, clinically significant arrhythmias (such as ventricular fibrillation, ventricular tachycardia, etc.); history of arterial thrombosis (such as stroke, transient ischemic attack) within 3 months prior to signing the ICF; history of symptomatic deep vein thrombosis, pulmonary embolism within 6 months prior to signing the ICF, or history of coronary artery angioplasty, defibrillation, or any clinical complications or diseases that may pose risks to the subject's safety or interfere with the study evaluation, procedures, or completion.
- History or current evidence of any condition or disease that could interfere with the study results or, in the opinion of the investigator, is not in the best interest of the patient to participate.
- Active central nervous system disease, or a history of the central nervous system requiring treatment (such as epilepsy); or subjects with central nervous system metastatic disease, leptomeningeal disease, or metastatic spinal cord compression.
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 |
|---|---|---|
| ACT-001 CAR-NK cellSubjects were distributed into three dosage groups, each receiving a single dose of CAR-NK cells at levels of 1×10^8, 3×10^8, and 9×10^8 cells, respectively. | Biological | ACT-001 CAR-NK cell |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: From admission to 28 days after CAR-NK cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence and type of adverse events (AEs)
Time frame: From admission to 2 years after CAR-NK cells infusion
To identify the incidence and the type of AEs, including abnormalities in clinical, laboratory assessments, ECGs, echocardiography, vital sign assessments, and physical exams.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-001 CAR-NK cell in people with Multiple Myeloma, run by RenJi Hospital 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 24 inclusion and 15 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: opening soon, as of the sponsor's last update on 19 Sep 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Honghui Huang (862168383144, huanghonghui@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: From admission to 28 days after CAR-NK cells 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 19 Sep 2024.