Multiple Myeloma (MM)Early Phase 1NCT07539233

A Clinical Study to Evaluate the Safety and Preliminary Efficacy of QI-019B in Patients With Relapsed/Refractory Multiple Myeloma.

A Early Phase 1 study testing QI-019B Injection in people with Multiple Myeloma (MM), run by Institute of Hematology & Blood Diseases Hospital, China 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 single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of QI-019B in 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 (MM)
What is being tested?: QI-019B Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 15 Apr 2026to 1 Aug 2029
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

1. Age ≥ 18 years, any gender;
2. Diagnosed with multiple myeloma (MM) according to IMWG diagnostic criteria;
3. Have received at least 2 lines of anti-MM treatment, with at least one full treatment cycle per line, and experienced disease progression during the most recent anti-myeloma treatment or within 12 months after it, confirmed by available clinical evidence; or deemed by the investigator to be refractory to both immunomodulatory agents and proteasome inhibitors, with disease progression during the most recent anti-myeloma treatment or within 2 months after it (according to IMWG diagnostic criteria);
4. Disease must be measurable at screening, meeting one or more of the following criteria:
Serum M protein level ≥ 0.5 g/dL;
Or urine M protein level ≥ 200 mg/24h;

Show all 28Show fewer

Or involved serum free light chain ≥ 10 mg/dL with abnormal serum free light chain κ/λ ratio;
5. ECOG performance status 0-2, with an expected survival of ≥ 3 months;
6. Bone marrow function test results (from screening or within 2 months prior) meet the following requirements:
Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin allowed; for patients meeting the ≥ 6 g/dL hemoglobin requirement at screening, red blood cell transfusions are allowed to maintain hemoglobin ≥ 6 g/dL;
Absolute neutrophil count (ANC) ≥ 600/μL (no use of granulocyte colony-stimulating factor (G-CSF) within 1 week before screening or pegylated G-CSF within 2 weeks before screening);
Platelet count ≥ 50,000/μL;
Lymphocyte count ≥ 500/μL;
7. Normal renal function: Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥45 mL/min;
8. Liver function must meet the following criteria:
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0× the upper limit of normal (ULN);
Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤2.0× ULN (except for congenital hyperbilirubinemia, e.g., Gilbert's syndrome, direct bilirubin ≤1.5× ULN);
Albumin ≥3 g/dL;
9. Cardiac function must meet the following criteria:
Left ventricular ejection fraction ≥50% (by echocardiography or MUGA scan);
No clinically significant pericardial effusion;
No clinically significant electrocardiogram abnormalities;
10. Pulmonary function must meet the following criteria:
Blood oxygen saturation ≥90% without oxygen supplementation;
11. Women of childbearing potential must have a negative pregnancy test at screening and before drug infusion and must not be breastfeeding.
12. Men and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent until 1 year after the use of the study drug;
13. Men and women of childbearing potential must agree not to donate sperm or eggs (oocytes) or other reproductive cells from the time of signing the informed consent until 1 year after the use of the study drug;
14. The subject or their legal guardian agrees to participate in this clinical trial and signs the informed consent form (ICF), indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the study.

Who cannot join

1.During screening, participants who have received other anticancer treatments (based mainly on investigator judgment):
Received targeted therapy, epigenetic therapy, other investigational drugs, or treatment using invasive research medical devices within 5 half-lives;
Received immune/non-immune-directed systemic therapy within 1 week;
Received cytotoxic therapy within 2 weeks;
Received proteasome inhibitors within 2 weeks;
Received immunomodulatory therapy within 1 week.

Show all 28Show fewer

Received radiotherapy within 4 weeks (if the radiotherapy covered ≤5% of bone marrow reserve, the subject is eligible regardless of the radiotherapy end date);
2. Received allogeneic hematopoietic stem cell transplantation within 6 months or autologous hematopoietic stem cell transplantation within 3 months before infusion;
3. Had malignancies other than MM before screening, except for: malignancies treated with curative intent, with no known active disease ≥2 years prior to enrollment; or adequately treated non-melanoma skin cancer with no evidence of disease currently;
4. Received any treatment using vesicular stomatitis virus G (VSVG) pseudotyped virus;
5. Had severe, uncontrolled infection symptoms (bacterial, viral, fungal, etc.) during the screening period;
6. Within 6 months before infusion, tested positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA levels above the normal range; tested positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA levels above the normal range; tested positive for human immunodeficiency virus (HIV) antibody; or tested positive for syphilis;
7. Had symptomatic heart failure or other serious cardiac diseases such as severe arrhythmias:
New York Heart Association (NYHA) class III or IV congestive heart failure;
Experienced myocardial infarction or underwent coronary artery bypass graft (CABG) or coronary stent implantation within 6 months prior to signing the ICF;
Had clinically significant ventricular arrhythmias, or a history of unexplained syncope (excluding cases caused by vasovagal response or dehydration);
Had a history of severe non-ischemic cardiomyopathy;
8. Other clinically significant diseases, including:
Primary immunodeficiency;
Stroke or seizure within 6 months prior to screening;
Clear clinical evidence of dementia or altered mental status;
Parkinson's disease or Parkinsonian movement disorders or history thereof;
9. Undergoing surgery within 2 weeks of administration or planned surgery within 2 weeks after administration, except for surgeries under local anesthesia;
10. Administration of live attenuated vaccines within 1 month before dosing;
11. Known severe allergic reaction to QI-019B or any of its formulation components;
12. Known severe allergic reaction to tocilizumab;
13. Unsuitable for establishing intravenous access;
14. Other conditions deemed by the investigator to be unsuitable for participation in this study.

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

Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300000
Gang AN, PhD&MD, 008613502181109, angang@ihcams.ac.cn

Other trials in China

About this study

Read the detailed description

This investigator-initiated clinical study aims to evaluate QI-019B, the lentiviral vector that carries a BCMA/CD19-targeted CAR, in patients with relapsed or refractory multiple myeloma (MM). The study employs a dose-escalation design to assess safety, tolerability, and preliminary efficacy.

Conditions: Multiple Myeloma (MM)
Being tested: QI-019B Injection
Keywords: BCMA, CD19, CAR-T, in vivo
Medical subject headings: Multiple Myeloma

What participants receive

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

QI-019B InjectionDrug
QI-019B Injection is an in vivo administered CAR-T gene therapy product that uses a lentiviral vector as the delivery system. Its mechanism of action involves transducing and integrating into the target T cell genome in the patient through the lentiviral vector, achieving stable expression of the CAR transgene, thereby generating CAR-T cells within the body.

Study groups in NCT07539233
Study group	Role	What they receive
QI-019B Injection	Experimental	QI-019B Injection is an in vivo administered CAR-T gene therapy product that uses a lentiviral vector as the delivery system. Its mechanism of action involves transducing and integrating into the target T cell genome in the patient through the lentiviral vector, achieving stable expression of the CAR transgene, thereby generating CAR-T cells within the body. Receives: Drug: QI-019B Injection

What is being measured

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

The number and severity of dose-limiting toxicity (DLT)events
Dose-limiting toxicity (DLT) refers to a grade ≥3 toxic reaction that occurs within the DLT observation period and is considered by the investigator or collaborators to have a reasonable association with QI-019B treatment(toxicity grading is based on CTCAE 5.0 standards, while grading for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) follows the 2019 ASTCT consensus criteria)
Measured: Within 28 Days After QI-019B infusion
The total number, incidence, and severity of Adverse Events(AEs)
The total number, incidence, and severity of Adverse Events(AEs). All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Measured: Within 28 Days After QI-019B infusion

Secondary outcomes (8)

Overall response rate (ORR）
Clinical efficacy can be evaluated according to the 2016 International Myeloma Working Group consensus criteria.
Measured: Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of QI-019B
Complete response (CR) rate
sCR/CR can be evaluated according to the 2016 International Myeloma Working Group consensus criteria.
Measured: Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of QI-019B.
Duration of response (DOR)
DOR is defined as the interval between the first sCR, CR, VGPR, or PR after infusion and the disease progression or death.
Measured: Through study completion, an average of 2 year
Progression-free survival (PFS)
PFS is defined as the interval between a subject's receipt of QI-019B infusion and the first assessment of disease progression or death.
Measured: up to 2 years after treatment of QI-019B.
Overall survival (OS)
OS is defined as the interval between a subject's receipt of QI-019B infusion and death from any cause.
Measured: up to 2 years after treatment of QI-019B
Cmax
CAR-T kinetics would be detected by flow cytometry and droplet digital PCR in peripheral blood and bone marrow at each important time points. Cmax is the peak expansion value of CAR-T cells.
Measured: Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 17, Day 21, Day 24, Day 28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of QI-019B
Tmax
CAR-T kinetics would be detected by flow cytometry and droplet digital PCR in peripheral blood and bone marrow at each important time points. Tmax is the time of the occurrence of expansion peak.
Measured: Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 17, Day 21, Day 24, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of QI-019B.
AUC(0-day 28)
CAR-T kinetics would be detected by flow cytometry and droplet digital PCR in peripheral blood and bone marrow at each important time points. Cmax is the peak expansion value of CAR-T cells. AUC(0- day28) refers to the area under curve of CAR-T cell expansion between infusion and day 28 post infusion. They all reflect the pharmacokinetics.
Measured: Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 17, Day 21, Day 24, Day 28 after the treatment of QI-019B

Timeline

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

15 Apr 20261 Aug 2029

First posted20 Apr 2026
Study start15 Apr 2026 (estimated)
Primary completion1 Aug 2028 (estimated)
Study completion1 Aug 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07539233
Sponsor's protocol ID: IIT2026025
Status last verified: Apr 2026
First submitted: 13 Apr 2026
Last updated: 20 Apr 2026
Results posted: 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

RecruitingPhase 1
ELEVATE-MM: Elotuzumab, Iberdomide and Dexamethasone Post Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma
Myeloma, Multiple Myeloma
Not yet recruitingPhase 3
Study of CM336+CM313 Combination Therapy in Patients With Relapsed or Refractory Multiple Myeloma
Multiple Myeloma (MM)
Not yet recruitingPhase 1
Engineered Dendritic Cell Vaccines for Multiple Myeloma
Multiple Myeloma or Plasmacytoma
RecruitingPhase 1/2
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Multiple Myeloma (MM)

All Multiple Myeloma (MM) trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study to Evaluate the Safety and Preliminary Efficacy of QI-019B in Patients With Relapsed/Refractory Multiple Myeloma.
ClinicalTrials.gov ID: NCT07539233
Acronym / sponsor ID: IIT2026025
Conditions: Multiple Myeloma (MM)
Keywords: BCMA, CD19, CAR-T, in vivo
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 24 participants (estimated)
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
Study start: 15 Apr 2026 (estimated)
Primary completion: 1 Aug 2028 (estimated)
Study completion: 1 Aug 2029 (estimated)
First posted: 20 Apr 2026 (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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
QI-019B Injection	Experimental	Drug: QI-019B InjectionQI-019B Injection is an in vivo administered CAR-T gene therapy product that uses a lentiviral vector as the delivery system. Its mechanism of action involves transducing and integrating into the target T cell genome in the patient through the lentiviral vector, achieving stable expression of the CAR transgene, thereby generating CAR-T cells within the body.

Who may qualify

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

Key inclusion criteria (28 listed)

1. Age ≥ 18 years, any gender;
2. Diagnosed with multiple myeloma (MM) according to IMWG diagnostic criteria;
3. Have received at least 2 lines of anti-MM treatment, with at least one full treatment cycle per line, and experienced disease progression during the most recent anti-myeloma treatment or within 12 months after it, confirmed by available clinical evidence; or deemed by the investigator to be refractory to both immunomodulatory agents and proteasome inhibitors, with disease progression during the most recent anti-myeloma treatment or within 2 months after it (according to IMWG diagnostic criteria);
4. Disease must be measurable at screening, meeting one or more of the following criteria:
5. ECOG performance status 0-2, with an expected survival of ≥ 3 months;

Key exclusion criteria (28 listed)

1.During screening, participants who have received other anticancer treatments (based mainly on investigator judgment):
2. Received allogeneic hematopoietic stem cell transplantation within 6 months or autologous hematopoietic stem cell transplantation within 3 months before infusion;
3. Had malignancies other than MM before screening, except for: malignancies treated with curative intent, with no known active disease ≥2 years prior to enrollment; or adequately treated non-melanoma skin cancer with no evidence of disease currently;
4. Received any treatment using vesicular stomatitis virus G (VSVG) pseudotyped virus;
5. Had severe, uncontrolled infection symptoms (bacterial, viral, fungal, etc.) during the screening period;

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
QI-019B InjectionQI-019B Injection is an in vivo administered CAR-T gene therapy product that uses a lentiviral vector as the delivery system. Its mechanism of action involves transducing and integrating into the target T cell genome in the patient through the lentiviral vector, achieving stable expression of the CAR transgene, thereby generating CAR-T cells within the body.	Drug	QI-019B Injection

Primary outcome

The number and severity of dose-limiting toxicity (DLT)events
Time frame: Within 28 Days After QI-019B infusion
Dose-limiting toxicity (DLT) refers to a grade ≥3 toxic reaction that occurs within the DLT observation period and is considered by the investigator or collaborators to have a reasonable association with QI-019B treatment(toxicity grading is based on CTCAE 5.0 standards, while grading for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) follows the 2019 ASTCT consensus criteria)
The total number, incidence, and severity of Adverse Events(AEs)
Time frame: Within 28 Days After QI-019B infusion
The total number, incidence, and severity of Adverse Events(AEs). All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

8 secondary outcomes

Overall response rate (ORR）
Time frame: Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of QI-019B
Complete response (CR) rate
Time frame: Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of QI-019B.
Duration of response (DOR)
Time frame: Through study completion, an average of 2 year
Progression-free survival (PFS)
Time frame: up to 2 years after treatment of QI-019B.
Overall survival (OS)
Time frame: up to 2 years after treatment of QI-019B
Cmax
Time frame: Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 17, Day 21, Day 24, Day 28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of QI-019B
Tmax
Time frame: Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 17, Day 21, Day 24, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of QI-019B.
AUC(0-day 28)
Time frame: Baseline, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 17, Day 21, Day 24, Day 28 after the treatment of QI-019B

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 20 Apr 2026.

Related trials for Multiple Myeloma (MM)

RecruitingPhase 1
ELEVATE-MM: Elotuzumab, Iberdomide and Dexamethasone Post Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma
Myeloma, Multiple Myeloma
Not yet recruitingPhase 3
Study of CM336+CM313 Combination Therapy in Patients With Relapsed or Refractory Multiple Myeloma
Multiple Myeloma (MM)
Not yet recruitingPhase 1
Engineered Dendritic Cell Vaccines for Multiple Myeloma
Multiple Myeloma or Plasmacytoma
RecruitingPhase 1/2
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Multiple Myeloma (MM)

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.

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

008613502181109

angang@ihcams.ac.cn

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 QI-019B Injection in people with Multiple Myeloma (MM), run by Institute of Hematology & Blood Diseases Hospital, China 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 28 inclusion and 28 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 20 Apr 2026. 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?

The number and severity of dose-limiting toxicity (DLT)events (time frame: Within 28 Days After QI-019B 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?

On the ClinicalTrials.gov record for NCT07539233.

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 20 Apr 2026.