Multiple MyelomaEarly Phase 1NCT06407947

Study of CT071 Injection in High Risk Newly Diagnosed Multiple Myeloma

A Early Phase 1 study testing Chimeric antigen receptor modified T cells Infusion in people with Multiple Myeloma, run by Shanghai Changzheng Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This trial is a single-arm, single-center, open-label clinical trial to evaluate the safety, efficacy, and metabolism kinetics of CT071 in patients with high-risk newly diagnosed multiple myeloma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Chimeric antigen receptor modified T cells Infusion
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteChina
Study dates: 6 Jun 2024to 3 Jun 2027
Phase: Early Phase 1
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must meet all of the following criteria to be enrolled:
1.Volunteer to participate in the clinical trial; the participants themselves fully understand and are informed of this study, and sign the informed consent form and are willing to follow and able to complete all trial procedures;
2.Age ≥ 18 years, male or female;
3.Participants must have newly diagnosed with multiple myeloma according to International Myeloma Working Group diagnostic criteria 2014 ;
4.Measurable disease based on at least one of the following parameters (International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma 2016); the values for these parameters obtained up to 60 days prior to signing the Informed Consent Form including the results at the time of diagnosis may be used.
Serum M-protein ≥ 1.0 g/dL;

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Urine M-protein ≥ 200 mg/24 hr;
Serum free light chain (FLC): involved FLC level ≥ 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal.
5.Known to have the following high risk factors, i.e. At least one of the following conditions is met:
1)Meet any one or more of the cytogenetic criteria: del (17p); t (4; 14); t (14; 16); t (14; 20); 1q21 amplification ≥ 4 copies; 2)R-ISS stage 3; R2-ISS stages 3 and 4; 3)Presence of soft tissue extramedullary plasmacytoma 4)2%-5% in peripheral plasma cells;
6.Eastern Cooperative Oncology Group (ECOG) score 0-2;
7.Participants should meet the following test results (repeat tests are allowed):
1)Hematology: Absolute neutrophil (ANC) count ≥ 1.0 × 109/L; Platelet (PLT) ≥ 50 × 109/L; Hemoglobin (Hb) ≥ 7.5 g/dL; 2)Blood chemistry: Endogenous creatinine clearance ≥ 40 mL/min (see Appendix 1 using the Cockcroft-Gault formula); Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN; 3)International normalized ratio (INR), or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
8.Venous access required for collection can be established and there is no contraindication for cell collection.
9.Females of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be willing to use effective and reliable contraception for at least 12 months after CT071 infusion.
10.A male participant, if sexually active with a female of childbearing potential, is willing to use a highly effective and reliable method of contraception for 1 year after receiving trial treatment. All male participants absolutely refrain from donating sperm during the trial and for 1 year after receiving trial treatment.

Who cannot join

Participants were not enrolled in the trial if they met any of the following criteria:
Patients with non-secretory MM.
Prior treatment for MM other than up to 2 cycles of (bortezomib, lenalidomide, dexamethasone) for induction, including but not limited to cytotoxic therapy, proteasome inhibitors, immunomodulators, targeted therapy, radiotherapy (patients are eligible for this trial if the radiation field covers ≤ 5% bone marrow reserve regardless of the end date of radiotherapy), epigenetic therapy, etc.
Pregnant or lactating females.
Patients with severe mental disorders or altered mental status, history of central nervous system disease, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, memory impairment, spinal cord compression, psychiatric disease or any disease involving the central nervous system, or suspected central nervous system (CNS) metastasis, or any autoimmune disease involving the CNS, with or suspected CNS infiltration.
Participants had other malignancies, including the following that were considered to have been successfully treated: non-metastatic basal cell or squamous cell skin cancer, non-metastatic prostate cancer, carcinoma in situ of the breast or cervix, and non-muscle invasive bladder cancer.

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Active autoimmune disease that results in end organ damage or requires systemic immunosuppressive/systemic disease modifying drugs, including but not limited to Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus and other patients requiring long-term immunosuppressive therapy.
Have any uncontrolled active infection (defined as exhibiting persistent signs or symptoms associated with infection that do not improve despite appropriate anti-infective therapy), or other serious active viral, bacterial, or uncontrolled systemic fungal infection. I
Positive test results for biomarkers of any of the following pathogenic microorganisms: human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody (TPPA), hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) (core antigen [HBcAb] positive must have DNA copies below the lower limit of normal).
Vaccination with live attenuated vaccine or mRNA vaccine within 8 weeks and inactivated vaccine within 4 weeks prior to screening.
Patients who are allergic or intolerant to lymphodpletion drugs, tocilizumab, or allergic to the ingredients of CT071 cell infusion preparation (DMSO); Or previous history of other severe allergies, such as anaphylactic shock.
Clinically significant cardiac abnormalities, including but not limited to:
1)Uncontrolled congestive heart failure (New York Heart Association Class III or IV heart failure, see Appendix 3); 2)Myocardial infarction, coronary artery bypass grafting or unstable angina within 6 months prior to apheresis; 3)History of clinically significant uncontrolled cardiac arrhythmias such as ventricular arrhythmias; 4)History of severe non-ischemic cardiomyopathy; 5)Left ventricular ejection fraction (LVEF) < 50%, diagnosed by echocardiography, without clinically significant ECG abnormalities; 6)Other heart disease that, in the opinion of the investigator, may jeopardize the health of the participant when participating in this clinical trial.
12.Participants with known or suspected chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of the predicted normal value of spirometry, or other lung disease that, in the judgment of the investigator, significantly affects lung function or affects the safety of the participant, such as asthma, interstitial lung disease, diffuse lung disease, pulmonary infection, pulmonary embolism, etc.
13.No need for supplemental oxygen for maintenance and oxygen saturation < 92% in room air.
14.Participant has a history of stroke or seizure within 6 months prior to the screening period.
15.Has had major surgery before screening, or is planned to undergo major surgery after the trial treatment (excluding cataract and other surgery under local anesthesia). The investigator must discuss with the sponsor to determine whether a surgery is major surgery before enrolling the participant in the trial.
16.The participant has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 ≤ Grade 1 from toxicities attributable to previous treatments, except for alopecia, peripheral neuropathy, and other events that, in the judgment of the investigator, are unlikely to result in lymphodepletion or cumulative toxicities of CT071 treatment; 17.Other conditions considered inappropriate for participation in this clinical trial by the investigator.

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, 1 recruiting

Juan Du
Shanghai, Shanghai Municipality, 200000
Juan Du, 15800706091, juan_du@live.com
Juan Du, PhD
Recruiting

Other trials in China

About this study

Official title: Exploratory Clinical Trial of the Safety and Efficacy of CT071 Injection in Patients With High Risk Newly Diagnosed Multiple Myeloma

This trial is a single-arm, single-center, open-label clinical trial to evaluate the safety, efficacy, and metabolism kinetics of CT071 in patients with high-risk newly diagnosed multiple myeloma.

Read the detailed description

Conditions: Multiple Myeloma
Being tested: Chimeric antigen receptor modified T cells Infusion
Keywords: Multiple Myeloma, Chimeric antigen receptor modified T cells
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chimeric antigen receptor modified T cells InfusionDrug
Also called Single Group Assignment
chimeric antigen receptor T cells

Study groups in NCT06407947
Study group	Role	What they receive
Chimeric antigen receptor modified T cells Infusion	Experimental	Chimeric antigen receptor modified T cells chimeric antigen receptor T cells Receives: Drug: Chimeric antigen receptor modified T cells Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events (AE) after CT071 infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), with the exception of cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS).
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Overall response rate (ORR)
ORR defined as proportion of patients achieving partial response or better based on International Myeloma Working Group defined response criteria
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Recommended Phase II Dose of CT071 in patients with high-risk newly diagnosed multiple myeloma
Evaluate Dose limited toxicity and adverse events after CT071 infusion
Measured: Assessed from the date of first dose of study treatment until 28 days

Secondary outcomes (15)

Minimal residual disease (MRD) negative rate
Minimal residual disease (MRD) negative rate is defined as the proportion of patients with Very good partial response or better who achieved 10-5 sensitivity of nucleated cell
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Complete response/stringent complete response (CR/sCR) rate
Rate of complete response/stringent complete response (CR/sCR) defined as proportion of patients achieving CR or better based on International Myeloma Working Group defined response criteria
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Duration of response (DOR)
DOR is defined as the time from first achieving partial response or better to confirmed disease progression or death from any cause
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Progression-free survival (PFS)
PFS defined as the time from the date of apheresis of the subject to the first assessment of confirmed disease progression or death from any cause according to International Myeloma Working Group 2016 criteria, whichever occurs first
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Time to response (TTR)
TTR defined as the time from the date of apheresis to the date of initial assessment of Partial response or better according to International Myeloma Working Group 2016 criteria
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Time to best response (TTBR) as assessed by the investigator
TTBR defined as the time from the date of apheresis to the date of assessment with a best response according to International Myeloma Working Group 2016 criteria
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Overall survival (OS)
OS defined as the time from the date of apheresis of the subject to death from any cause
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Peak Plasma Concentration (Cmax) of CAR T cells
time to Peak Plasma Concentration (Cmax)
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Presence of anti-CT071 antibodies
Anti-drug antibody positive rate
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Duration of MRD negativity
Sustain MRD negative month
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Cytokines in the peripheral blood after CT071 infusion
Serum concentrations of granulocyte-macrophage colony stimulating factor (GM-CSF) interleukin (IL)-6, IL-10, interferon gamma (IFN-γ) and tumor necrosis factor (TNF),after CT071 infusion
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Immune-related proteins after CT071 infusion
Serum concentrations of C-reactive protein (CRP),etc.
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Markers
Expresion of soluble GPRC5D (sGPRC5D)
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Area under the plasma concentration versus time curve (AUC) of CART cells
Area under the plasma concentration versus time curve (AUC)
Measured: From first dose of study drug administration to end of treatment (up to 24 months)
Level of CAR-T Cell Expansion persistence
Levels of cell expansion persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported.
Measured: From first dose of study drug administration to end of treatment (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.

6 Jun 20243 Jun 2027

First posted9 May 2024
Study start6 Jun 2024
Primary completion3 Jun 2027 (estimated)
Study completion3 Jun 2027 (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 Shanghai Changzheng 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: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06407947
Sponsor's protocol ID: CT071-CG7002
Status last verified: Jun 2024
First submitted: 6 May 2024
Last updated: 12 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploratory Clinical Trial of the Safety and Efficacy of CT071 Injection in Patients With High Risk Newly Diagnosed Multiple Myeloma
ClinicalTrials.gov ID: NCT06407947
Acronym / sponsor ID: CT071-CG7002
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma, Chimeric antigen receptor modified T cells
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 10 participants (estimated)
Lead sponsor: Shanghai Changzheng HospitalUniversity, hospital or other
Collaborators: CARsgen Therapeutics Co., Ltd.
Study start: 6 Jun 2024 (actual)
Primary completion: 3 Jun 2027 (estimated)
Study completion: 3 Jun 2027 (estimated)
First posted: 9 May 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 trial is a single-arm, single-center, open-label clinical trial to evaluate the safety, efficacy, and metabolism kinetics of CT071 in patients with high-risk newly diagnosed multiple myeloma.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Chimeric antigen receptor modified T cells Infusion	Experimental	Drug: Chimeric antigen receptor modified T cells InfusionChimeric antigen receptor modified T cells chimeric antigen receptor T cells

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

1.Volunteer to participate in the clinical trial; the participants themselves fully understand and are informed of this study, and sign the informed consent form and are willing to follow and able to complete all trial procedures;
2.Age ≥ 18 years, male or female;
3.Participants must have newly diagnosed with multiple myeloma according to International Myeloma Working Group diagnostic criteria 2014 ;
4.Measurable disease based on at least one of the following parameters (International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma 2016); the values for these parameters obtained up to 60 days prior to signing the Informed Consent Form including the results at the time of diagnosis may be used.
Serum M-protein ≥ 1.0 g/dL;

Key exclusion criteria (18 listed)

1)Uncontrolled congestive heart failure (New York Heart Association Class III or IV heart failure, see Appendix 3); 2)Myocardial infarction, coronary artery bypass grafting or unstable angina within 6 months prior to apheresis; 3)History of clinically significant uncontrolled cardiac arrhythmias such as ventricular arrhythmias; 4)History of severe non-ischemic cardiomyopathy; 5)Left ventricular ejection fraction (LVEF) < 50%, diagnosed by echocardiography, without clinically significant ECG abnormalities; 6)Other heart disease that, in the opinion of the investigator, may jeopardize the health of the participant when participating in this clinical trial.
12.Participants with known or suspected chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of the predicted normal value of spirometry, or other lung disease that, in the judgment of the investigator, significantly affects lung function or affects the safety of the participant, such as asthma, interstitial lung disease, diffuse lung disease, pulmonary infection, pulmonary embolism, etc.
13.No need for supplemental oxygen for maintenance and oxygen saturation < 92% in room air.
14.Participant has a history of stroke or seizure within 6 months prior to the screening period.
15.Has had major surgery before screening, or is planned to undergo major surgery after the trial treatment (excluding cataract and other surgery under local anesthesia). The investigator must discuss with the sponsor to determine whether a surgery is major surgery before enrolling the participant in the trial.

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
Chimeric antigen receptor modified T cells InfusionAlso: Single Group Assignmentchimeric antigen receptor T cells	Drug	Chimeric antigen receptor modified T cells Infusion

Primary outcome

Adverse Events (AE) after CT071 infusion
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), with the exception of cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS).
Overall response rate (ORR)
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
ORR defined as proportion of patients achieving partial response or better based on International Myeloma Working Group defined response criteria
Recommended Phase II Dose of CT071 in patients with high-risk newly diagnosed multiple myeloma
Time frame: Assessed from the date of first dose of study treatment until 28 days
Evaluate Dose limited toxicity and adverse events after CT071 infusion

15 secondary outcomes

Minimal residual disease (MRD) negative rate
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
Complete response/stringent complete response (CR/sCR) rate
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
Duration of response (DOR)
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
Progression-free survival (PFS)
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
Time to response (TTR)
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
Time to best response (TTBR) as assessed by the investigator
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
Overall survival (OS)
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
Peak Plasma Concentration (Cmax) of CAR T cells
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
Presence of anti-CT071 antibodies
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
Duration of MRD negativity
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
Cytokines in the peripheral blood after CT071 infusion
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
Immune-related proteins after CT071 infusion
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
Markers
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
Area under the plasma concentration versus time curve (AUC) of CART cells
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)
Level of CAR-T Cell Expansion persistence
Time frame: From first dose of study drug administration to end of treatment (up to 24 months)

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 12 Jun 2024.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

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.

Juan Du

Shanghai, China

15800706091

juan_du@live.com

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 Chimeric antigen receptor modified T cells Infusion in people with Multiple Myeloma, run by Shanghai Changzheng 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 16 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 12 Jun 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.

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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AE) after CT071 infusion (time frame: From first dose of study drug administration to end of treatment (up to 24 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06407947.

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 12 Jun 2024.