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

N

Novatim Immune Therapeutics

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Multiple Myeloma

Treatments

Biological: KQ-2003 CAR T-cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT06223646
KQ-2003-AC101

Details and patient eligibility

About

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

Enrollment

29 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

29 participants in 4 patient groups

Phase 1: Low dose group
Experimental group
Description:
Infusion of KQ-2003 CAR T-cells by single dose of 1.0×10^6 CAR-T cells/kg
Treatment:
Biological: KQ-2003 CAR T-cells
Phase 1: Medium dose group
Experimental group
Description:
Infusion of KQ-2003 CAR T-cells by single dose of 2.0×10^6 CAR-T cells/kg
Treatment:
Biological: KQ-2003 CAR T-cells
Phase 1: High dose group
Experimental group
Description:
Infusion of KQ-2003 CAR T-cells by single dose of 3.0×10^6 CAR-T cells/kg
Treatment:
Biological: KQ-2003 CAR T-cells
Phase 2a: RP2D
Experimental group
Description:
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.
Treatment:
Biological: KQ-2003 CAR T-cells

Trial contacts and locations

1

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Central trial contact

Jian Li, M.D.

Data sourced from clinicaltrials.gov

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