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Trial Title:
A Study of KQ-2003 CAR-T Cell Therapy for Patients With Relapsed or Refractory Multiple Myeloma
NCT ID:
NCT06223646
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
KQ-2003 CAR T-cells
Description:
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.
Arm group label:
Phase 1: High dose group
Arm group label:
Phase 1: Low dose group
Arm group label:
Phase 1: Medium dose group
Arm group label:
Phase 2a: RP2D
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Li, M.D.
Phone:
01065296114
Email:
lijian@pumch.cn
Start date:
January 11, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
Agency class:
Industry
Source:
Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06223646
