KQ-2003 CAR-T cell therapy for relapsed or refractory multiple myeloma

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

This study is testing a new CAR-T cell therapy for people with relapsed or hard-to-treat multiple myeloma to see how safe it is and what the best dose might be.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Novatim Immune Therapeutics (Zhejiang) Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T, cyclophosphamide, fludarabine, CAR T
• Locations: 1 site (Beijing)
• Trial ID: NCT06223646 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label study aims to evaluate the safety and tolerability of KQ-2003 CAR T-cell therapy in patients with relapsed or refractory multiple myeloma. It involves a dose-escalation and expansion approach to determine the recommended dose of the therapy. Participants will undergo apheresis to collect peripheral blood mononuclear cells, which will be modified to create the CAR T-cells. The study will monitor pharmacokinetic and pharmacodynamic characteristics to assess the treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory multiple myeloma and an ECOG performance status of 2 or less.

Not a fit: Patients who have received recent treatments that may affect CAR-T cell activity or have active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat multiple myeloma.

How similar studies have performed: Other studies involving CAR-T cell therapies have shown promising results in treating hematological malignancies, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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

Where this trial is running

Beijing

• Chinese Academy of Medical Sciences & Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Jian Li, M.D.

Conditions Multiple Myeloma