POEMS SyndromePhase 1NCT06518876

A Study of KQ-2003 CAR-T Cell Therapy for Patients With Relapsed or Refractory POEMS Syndrome

A Phase 1 study testing KQ-2003 CAR T-cells in people with POEMS Syndrome, run by Novatim Immune Therapeutics (Zhejiang) Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

This is a multicenter, open-label, dose-escalation/expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and determine the recommended dose of KQ-2003 CAR T-cells for patients with Relapsed/Refractory POEMS Syndrome Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: POEMS Syndrome
What is being tested?: KQ-2003 CAR T-cells
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteChina
Study dates: 31 Aug 2024to 31 Dec 2027
Phase: 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

Age ≥18 years old, male or female;
Diagnosis of POEMS syndrome with relapsed or refractory disease;
Eastern Cooperative Oncology Group (ECOG) Performance ≤2 ;
Adequate venous access for the apheresis of peripheral blood mononuclear cell;
Vascular Endothelial Growth Factor (VEGF) ≥1200ng/L；
Overall Neuropathy Limitations Scale (ONLS) ≥ 1;
Adequate organ function;
Able and willing to comply with the study protocol and follow-up plan, and sign the informed consent form in writing.

Who cannot join

Subjects who had previously received BCMA-CD19 dual-target CAR-T cell products or autologous stem cell transplantation within 12 weeks before the collection of peripheral blood mononuclear cells;
Known allergy or hypersensitivity reactions to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO), CD19, or BCMA-targeted drugs;
Received any treatment that might influence the activity of CAR-T cells prior to the collection of peripheral blood mononuclear cells;
Have history of vaccination within the 4 weeks preceding the collection of peripheral blood mononuclear cells;
Have tested positive for cytomegalovirus and/or mycobacterium tuberculosis, or had any uncontrolled active infection within 14 days prior to the collection of peripheral blood mononuclear cells;
Subjects infected with active HBV or HCV, HIV, syphilis;

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Subjects with known central nervous system disease, for example, seizure disorders, clinically significant cerebral ischemia/hemorrhage, dementia);
Subjects currently experiencing active autoimmune diseases; Diagnosed with immunodeficiency or receiving any other form of immunosuppressive therapy within 7 days prior to enrollment in this study;
Subjects with active bleeding or VTE events (such as pulmonary embolism or deep vein thrombosis) require anticoagulation;
Have following severe diseases: unstable angina, cerebrovascular accident or transient ischemic attack, myocardial infarction , New York Heart Association (NYHA) Class ≥ III, congestive heart failure, poorly controlled severe arrhythmias or other cardiac diseases requiring mechanical support; subjects with known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal; subjects with known moderate or severe persistent asthma, or a history of asthma within the past 2 years, or currently having any category of uncontrolled asthma; subjects requiring oxygen to maintain adequate oxygen saturation; subjects with hypertension whose blood pressure cannot be lowered to the following range despite treatment with two or more antihypertensive medications;
Have active malignancies;
Have any non-hematologic toxicity resulting from prior treatments that cannot be restored to ≤ grade 1 or baseline, excluding alopecia and grade 2 neuropathy;
Subjects had participated in other clinical trials and used its investigational drugs within the 3 months prior to the collection of peripheral blood mononuclear cells;
History of alcohol abuse, drug addiction, substance abuse, or mental illness within the past year;
Pregnant or lactating women;
Any situation that the investigator believes may increase the risk of subjects or interfere with the results of clinical trials

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jian Li, M.D. contact

010-65296114

lijian@pumch.cn

China1 site

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, 100730
Jian Li, M.D., 010-65296114, lijian@pumch.cn

Other trials in China

About this study

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, and Pharmacokinetic Characterization of KQ-2003 for Patients With Relapsed/Refractory POEMS Syndrome

Read the detailed description

The study included the phase 1a dose escalation study and the phase 1b cohort extension study. The phase 1a study is an open, dose-escalation design with 3 dose groups according to the "3+3" dose escalation rule: low dose group (0.5×10^6 CAR T cells/kg), medium dose group (1.0×10^6 CAR T cells/kg), high dose group (2.0×10^6 CAR T cells/kg). After initial confirmation of maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), a phase 1b cohort extension study will be conducted.

Conditions: POEMS Syndrome
Being tested: KQ-2003 CAR T-cells
Medical subject headings: POEMS Syndrome

What participants receive

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

KQ-2003 CAR T-cellsBiological
KQ-2003 CAR T-cell therapy involves autologous chimeric antigen receptor T-cells, capable of targeting both human B cell maturation antigen (anti-BCMA CAR) and CD19 antigen molecules (anti-CD19 CAR) simultaneously as a cellular therapy.

Study groups in NCT06518876
Study group	Role	What they receive
Phase 1a: Low dose group	Experimental	Infusion of KQ-2003 CAR T-cells by single dose of 0.5×10^6 CAR-T cells/kg Receives: Biological: KQ-2003 CAR T-cells
Phase 1a: Medium dose group	Experimental	Infusion of KQ-2003 CAR T-cells by single dose of 1.0×10^6 CAR-T cells/kg Receives: Biological: KQ-2003 CAR T-cells
Phase 1a: High dose group	Experimental	Infusion of KQ-2003 CAR T-cells by single dose of 2.0×10^6 CAR-T cells/kg Receives: Biological: KQ-2003 CAR T-cells
Phase 1b: RP2D	Experimental	After all subjects in the Phase 1a dose-escalation study completed DLT observation, RP2D was determined based on the analysis results for the phase 1b expansion study. Receives: Biological: KQ-2003 CAR T-cells

What is being measured

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

Number of patients with dose-limiting toxicity (DLT)
For DLT evaluation, severity (grade) is classified according to common terminology criteria for adverse events version 5.0 (CTCAE v5.0).
Measured: Within 28 days of receiving KQ-2003 CAR T-cells transfusion therapy
Adverse Event
Safety will be assessed by adverse events (AEs), which include clinically significant abnormalities identified during a medical test (e.g. laboratory tests, electrocardiogram, vital signs, physical examinations). AEs will be coded by Medical Dictionary for Regulatory Activities (MedDRA) and their severity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Maximum Tolerated Dose (MTD)
At least 6 subjects in the MTD dose group must complete the DLT assessment.
Measured: Within 28 days of receiving KQ-2003 CAR T-cells transfusion therapy
Recommended Phase 2 Dose (RP2D)
To determine after all subjects in the Phase 1 dose-escalation study completed DLT observation
Measured: Through study completion, an average of 1 year

Secondary outcomes (22)

Response of serum vascular endothelial growth factor level(VEGF)
The improvements of serum VEGF will be assessed every three months by evaluating changes from baseline and will be described descriptively.
Measured: Through study completion, an average of 2 years
Hematologic response
Hematologic response is also a criterion for assessing the efficacy of treatment for POEMS syndrome. The improvements of serum protein electrophoresis (SPEP) and immunofixation electrophoresis (IFE) will be assessed every three months by evaluating changes from baseline and will be described descriptively.
Measured: Through study completion, an average of 2 years
Response of positron emission tomography-scan (PET-CT)
Observe the change in FDG uptake in the lesions of the subjects compared to the baseline, assessed every three months.
Measured: Through study completion, an average of 2 years
Response rate of critical organs
Evaluate the changes in clinical symptoms compared to the baseline according to CTCAE 5.0. The assessment of clinical efficacy is conducted every three months after KQ-2003 CAR T-cells transfusion therapy.
Measured: Through study completion, an average of 2 years
Complete response rate (CRR)
The definition of CRR is the proportion of subjects achieving CR confirmed by efficacy re-assessment after a minimum interval of three months.
Measured: Through study completion, an average of 2 years
Disease-free survival (DFS)
DFS refers to time from treatment until the recurrence of disease (or death) after undergoing the study treatment.
Measured: Through study completion, an average of 2 years
Overall survival (OS)
OS is the time from the start of cell infusion to the death of the subject.
Measured: Through study completion, an average of 2 years
Maximum concentration (Cmax)
Blood and bone marrow samples will be collected and used for pharmacokinetics assessments.
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Time to maximum plasma concentration (Tmax)
Blood and bone marrow samples will be collected and used for pharmacokinetics
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Levels of IL-2
Blood samples will be collected and used for pharmacodynamic to evaluate the levels about cytokine levels
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Levels of IL-6
Blood samples will be collected and used for pharmacodynamic to evaluate the levels about cytokine levels
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Levels of IL-10
Blood samples will be collected and used for pharmacodynamic to evaluate the levels about cytokine levels
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Levels of TNF-α
Blood samples will be collected and used for pharmacodynamic to evaluate the levels about cytokine levels
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Levels of IFN-γ
Blood samples will be collected and used for pharmacodynamic to evaluate the levels about cytokine levels
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Levels of C-reactive protein (CRP)
Blood samples will be collected and used for pharmacodynamic to evaluate the levels
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Levels of ferritin
Blood samples will be collected and used for pharmacodynamic to evaluate the levels
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
CD19+B lymphocyte count
Blood samples will be collected and used for pharmacodynamic to evaluate the levels about peripheral blood lymphocyte subsets
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
CD20+B lymphocyte count
Blood samples will be collected and used for pharmacodynamic to evaluate the levels about peripheral blood lymphocyte subsets
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
CD3+T lymphocyte count
Blood samples will be collected and used for pharmacodynamic to evaluate the levels about peripheral blood lymphocyte subsets
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
CD4+T lymphocyte count
Blood samples will be collected and used for pharmacodynamic to evaluate the levels about peripheral blood lymphocyte subsets
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
CD8+T lymphocyte count
Blood samples will be collected and used for pharmacodynamic to evaluate the levels about peripheral blood lymphocyte subsets
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
ADA
The trial will evaluate the positive rate, titer and duration or persistence of ADA following the administration of CAR T-Cells.
Measured: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Aug 202431 Dec 2027

First posted24 Jul 2024
Study start31 Aug 2024 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for POEMS SyndromeStudies 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: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 21 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06518876
Sponsor's protocol ID: KQ-2003-BC101
Status last verified: Jul 2024
First submitted: 8 Jul 2024
Last updated: 24 Jul 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Jian Li, M.D.

010-65296114

lijian@pumch.cn

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

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BCMA/CD3 BsAb Therapy for POEMS Syndrome
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Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Vasculitic Neuropathy
RecruitingPhase 2
KCD (Carfilzomib/Cyclophosphamide/Dexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome
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One Gene, Two Diseases: the Pathologic Role of IGLV1-44 in AL Amyloidosis and POEMS
AL Amyloidosis, POEMS Syndrome

All POEMS Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, and Pharmacokinetic Characterization of KQ-2003 for Patients With Relapsed/Refractory POEMS Syndrome
ClinicalTrials.gov ID: NCT06518876
Acronym / sponsor ID: KQ-2003-BC101
Conditions: POEMS Syndrome
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 21 participants (estimated)
Lead sponsor: Novatim Immune Therapeutics (Zhejiang) Co., Ltd.Industry (pharma, biotech, devices)
Study start: 31 Aug 2024 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 24 Jul 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Phase 1a: Low dose group	Experimental	Biological: KQ-2003 CAR T-cellsInfusion of KQ-2003 CAR T-cells by single dose of 0.5×10^6 CAR-T cells/kg
Phase 1a: Medium dose group	Experimental	Biological: KQ-2003 CAR T-cellsInfusion of KQ-2003 CAR T-cells by single dose of 1.0×10^6 CAR-T cells/kg
Phase 1a: High dose group	Experimental	Biological: KQ-2003 CAR T-cellsInfusion of KQ-2003 CAR T-cells by single dose of 2.0×10^6 CAR-T cells/kg
Phase 1b: RP2D	Experimental	Biological: KQ-2003 CAR T-cellsAfter all subjects in the Phase 1a dose-escalation study completed DLT observation, RP2D was determined based on the analysis results for the phase 1b expansion study.

Who may qualify

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

Key inclusion criteria (8 listed)

Age ≥18 years old, male or female;
Diagnosis of POEMS syndrome with relapsed or refractory disease;
Eastern Cooperative Oncology Group (ECOG) Performance ≤2 ;
Adequate venous access for the apheresis of peripheral blood mononuclear cell;
Vascular Endothelial Growth Factor (VEGF) ≥1200ng/L；

Key exclusion criteria (16 listed)

Subjects who had previously received BCMA-CD19 dual-target CAR-T cell products or autologous stem cell transplantation within 12 weeks before the collection of peripheral blood mononuclear cells;
Known allergy or hypersensitivity reactions to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO), CD19, or BCMA-targeted drugs;
Received any treatment that might influence the activity of CAR-T cells prior to the collection of peripheral blood mononuclear cells;
Have history of vaccination within the 4 weeks preceding the collection of peripheral blood mononuclear cells;
Have tested positive for cytomegalovirus and/or mycobacterium tuberculosis, or had any uncontrolled active infection within 14 days prior to the collection of peripheral blood mononuclear cells;

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
KQ-2003 CAR T-cellsKQ-2003 CAR T-cell therapy involves autologous chimeric antigen receptor T-cells, capable of targeting both human B cell maturation antigen (anti-BCMA CAR) and CD19 antigen molecules (anti-CD19 CAR) simultaneously as a cellular therapy.	Biological	Phase 1a: High dose group, Phase 1a: Low dose group, Phase 1a: Medium dose group, Phase 1b: RP2D

Primary outcome

Number of patients with dose-limiting toxicity (DLT)
Time frame: Within 28 days of receiving KQ-2003 CAR T-cells transfusion therapy
For DLT evaluation, severity (grade) is classified according to common terminology criteria for adverse events version 5.0 (CTCAE v5.0).
Adverse Event
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Safety will be assessed by adverse events (AEs), which include clinically significant abnormalities identified during a medical test (e.g. laboratory tests, electrocardiogram, vital signs, physical examinations). AEs will be coded by Medical Dictionary for Regulatory Activities (MedDRA) and their severity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).
Maximum Tolerated Dose (MTD)
Time frame: Within 28 days of receiving KQ-2003 CAR T-cells transfusion therapy
At least 6 subjects in the MTD dose group must complete the DLT assessment.
Recommended Phase 2 Dose (RP2D)
Time frame: Through study completion, an average of 1 year
To determine after all subjects in the Phase 1 dose-escalation study completed DLT observation

22 secondary outcomes

Response of serum vascular endothelial growth factor level(VEGF)
Time frame: Through study completion, an average of 2 years
Hematologic response
Time frame: Through study completion, an average of 2 years
Response of positron emission tomography-scan (PET-CT)
Time frame: Through study completion, an average of 2 years
Response rate of critical organs
Time frame: Through study completion, an average of 2 years
Complete response rate (CRR)
Time frame: Through study completion, an average of 2 years
Disease-free survival (DFS)
Time frame: Through study completion, an average of 2 years
Overall survival (OS)
Time frame: Through study completion, an average of 2 years
Maximum concentration (Cmax)
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Time to maximum plasma concentration (Tmax)
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Levels of IL-2
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Levels of IL-6
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Levels of IL-10
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Levels of TNF-α
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Levels of IFN-γ
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Levels of C-reactive protein (CRP)
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
Levels of ferritin
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
CD19+B lymphocyte count
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
CD20+B lymphocyte count
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
CD3+T lymphocyte count
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
CD4+T lymphocyte count
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
CD8+T lymphocyte count
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
ADA
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)

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 24 Jul 2024.

Related trials for POEMS Syndrome

RecruitingPhase 2
BCMA/CD3 BsAb Therapy for POEMS Syndrome
POEMS Syndrome
RecruitingObservational study
A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH
Multiple Myeloma, Amyloidosis
Active, not recruitingObservational study
Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Vasculitic Neuropathy
RecruitingPhase 2
KCD (Carfilzomib/Cyclophosphamide/Dexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome
POEMS Syndrome
RecruitingObservational study
One Gene, Two Diseases: the Pathologic Role of IGLV1-44 in AL Amyloidosis and POEMS
AL Amyloidosis, POEMS Syndrome

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.

Jian Li, M.D. contact

010-65296114

lijian@pumch.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KQ-2003 CAR T-cells in people with POEMS Syndrome, run by Novatim Immune Therapeutics (Zhejiang) Co., Ltd. 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 16 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 24 Jul 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Jian Li, M.D. (010-65296114, lijian@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with dose-limiting toxicity (DLT) (time frame: Within 28 days of receiving KQ-2003 CAR T-cells transfusion therapy). The study lists 4 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 NCT06518876.

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 24 Jul 2024.