Multiple MyelomaPhase 1/2NCT06223646

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

A Phase 1/2 study testing KQ-2003 CAR T-cells in people with Multiple Myeloma, run by Novatim Immune Therapeutics (Zhejiang) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is a multicenter, open-label, dose-escalation/expansion phase 1/2a 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 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?: 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: 29 participants
Where: 1 siteChina
Study dates: 11 Jan 2024to 31 Mar 2026
Phase: Phase 1/2
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 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 MM with relapsed or refractory disease;
Eastern Cooperative Oncology Group (ECOG) Performance ≤2 ;
Expected survival of at least 12 weeks;
Participant has measurable disease;
Adequate venous access for the apheresis of peripheral blood mononuclear cell;
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

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 active bleeding or venous thromboembolic events requiring anticoagulation;
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;
Subjects with known central nervous system disease or multiple myeloma involving the central nervous system (CNS) or presenting with CNS-related symptoms;

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Patients 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.
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;.
Subjects with malignancies other than multiple myeloma;
Have any non-hematologic toxicity resulting from prior treatments that cannot be restored to ≤ grade 1 or baseline, excluding alopecia and grade 2 neuropathy;
History of alcohol abuse, drug addiction, substance abuse, or mental illness within the past year;
Presence of acute graft-versus-host disease (GVHD) or extensive chronic GVHD of Grade ≥ 2 requiring treatment within the 4 weeks before enrollment, or as judged by the investigator to likely require anti-GVHD treatment during the study; 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;
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
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.

Jian Li, M.D. contact

010-65296114

lijian@pumch.cn

China1 site, 1 recruiting

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, 100730
Jian Li, M.D., 01065296114, lijian@pumch.cn
Recruiting

Other trials in China

About this study

Official title: A Phase 1/2a Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, and Pharmacokinetic Characterization of KQ-2003 for Patients With Relapsed/Refractory Multiple Myeloma

Conditions: Multiple Myeloma
Being tested: KQ-2003 CAR 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.

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 NCT06223646
Study group	Role	What they receive
Phase 1: Low 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 1: Medium 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 1: High dose group	Experimental	Infusion of KQ-2003 CAR T-cells by single dose of 3.0×10^6 CAR-T cells/kg Receives: Biological: KQ-2003 CAR T-cells
Phase 2a: RP2D	Experimental	After all subjects in the Phase 1 dose-escalation study completed DLT observation, RP2D was determined based on the analysis results for the phase 2a 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
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
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)
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
Objective response rate (ORR)
The definition of ORR is the proportion of subjects achieving sCR, CR, VGPR, or PR confirmed by efficacy reassessment after a minimum interval of three months. ORR is calculated as (sCR+CR+VGPR+PR) divided by the total number of cases, multiplied by 100%.
Measured: Through study completion, an average of 2 years

Secondary outcomes (14)

Stringent complete response rate (sCRR)
The definition of sCRR is the proportion of subjects achieving sCR confirmed by efficacy re-assessment after a minimum interval of three months.
Measured: Through study completion, an average of 2 years
Duration of Response (DOR)
DOR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of progressive disease.
Measured: Through study completion, an average of 2 years
Disease Control Rate (DCR)
The proportion of subjects achieving sCR, CR, VGPR, PR, MR, or disease stability (SD) confirmed by efficacy reassessment after a minimum interval of three months is defined as the DCR.
Measured: Through study completion, an average of 2 years
Progression-free Survival (PFS)
The time interval from the first administration of the investigational drug to the first observation of disease progression is calculated, considering the date of entry for patients who died for reasons other than disease progression before progression occurred.
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
Microscopic Residual Disease (MRD) Negativity Rate and Duration
The duration of MRD negativity is the period during which both bone marrow MRD and imaging remain negative.
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-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 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)
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)
Nab
The trial will evaluate the positive rate, titer and duration or persistence of Nab 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.

11 Jan 202431 Mar 2026

First posted25 Jan 2024
Study start11 Jan 2024
Primary completion31 Mar 2026 (estimated)
Study completion31 Mar 2026 (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.
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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 29 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06223646
Sponsor's protocol ID: KQ-2003-AC101
Status last verified: Jan 2024
First submitted: 22 Dec 2023
Last updated: 25 Jan 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

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 locations

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RecruitingPhase 2
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Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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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
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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2a Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, and Pharmacokinetic Characterization of KQ-2003 for Patients With Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT06223646
Acronym / sponsor ID: KQ-2003-AC101
Conditions: Multiple Myeloma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 29 participants (estimated)
Lead sponsor: Novatim Immune Therapeutics (Zhejiang) Co., Ltd.Industry (pharma, biotech, devices)
Study start: 11 Jan 2024 (actual)
Primary completion: 31 Mar 2026 (estimated)
Study completion: 31 Mar 2026 (estimated)
First posted: 25 Jan 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.

Study design

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

Arm	Type	Receives
Phase 1: Low 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 1: Medium 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 1: High dose group	Experimental	Biological: KQ-2003 CAR T-cellsInfusion of KQ-2003 CAR T-cells by single dose of 3.0×10^6 CAR-T cells/kg
Phase 2a: RP2D	Experimental	Biological: KQ-2003 CAR T-cellsAfter all subjects in the Phase 1 dose-escalation study completed DLT observation, RP2D was determined based on the analysis results for the phase 2a 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 MM with relapsed or refractory disease;
Eastern Cooperative Oncology Group (ECOG) Performance ≤2 ;
Expected survival of at least 12 weeks;
Participant has measurable disease;

Key exclusion criteria (17 listed)

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 active bleeding or venous thromboembolic events requiring anticoagulation;
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;

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 1: High dose group, Phase 1: Low dose group, Phase 1: Medium dose group, Phase 2a: 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).
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.
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).
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
Objective response rate (ORR)
Time frame: Through study completion, an average of 2 years
The definition of ORR is the proportion of subjects achieving sCR, CR, VGPR, or PR confirmed by efficacy reassessment after a minimum interval of three months. ORR is calculated as (sCR+CR+VGPR+PR) divided by the total number of cases, multiplied by 100%.

14 secondary outcomes

Stringent complete response rate (sCRR)
Time frame: Through study completion, an average of 2 years
Duration of Response (DOR)
Time frame: Through study completion, an average of 2 years
Disease Control Rate (DCR)
Time frame: Through study completion, an average of 2 years
Progression-free Survival (PFS)
Time frame: Through study completion, an average of 2 years
Overall Survival (OS)
Time frame: Through study completion, an average of 2 years
Microscopic Residual Disease (MRD) Negativity Rate and Duration
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-6
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)
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)
Nab
Time frame: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 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. This study is not recruiting at the moment.

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 1/2 study testing KQ-2003 CAR T-cells in people with Multiple Myeloma, 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 17 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 25 Jan 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 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 5 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 NCT06223646.

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 25 Jan 2024.