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Recruiting NCT07075185

A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma

Phase I Interventional Multiple Myeloma in Relapse Myeloma Multiple Multiple Myeloma Progression Neoplasms by Histologic Type

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KLN-1010.
Who it may be relevant to
Registry conditions: Multiple Myeloma in Relapse, Myeloma Multiple, Multiple Myeloma Progression, Neoplasms by Histologic Type. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1 Study to Evaluate the Safety of KLN-1010, a Novel, In Vivo Gene Therapy to Generate Anti-B Cell Maturation Antigen (Anti-BCMA) Chimeric Antigen Receptor-T Cells (CAR-T) in Patients With Relapsed and Refractory Multiple Myeloma

Overview

The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.

Interventions

  • Drug KLN-1010
    Given at specified dose one time

Primary outcome measures

  • Incidence and severity of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs), and/or establish the recommended Phase 2 Dose [Time frame: Up to 15 years from dosing of KLN-1010]
Secondary outcome measures (7)
  • Pharmacokinetics of KLN-1010 after dosing. [Time frame: Up to two years after dosing with study drug.]
  • Pharmacokinetics of KLN-1010 (Tmax). [Time frame: Up to two years after infusion with study drug.]
  • Pharmacokinetics of KLN-1010 Area Under the Curve (AUC) [Time frame: Up to two years after infusion with study drug.]
  • Pharmacokinetics of CAR-T cells generated. [Time frame: Up to two years after infusion with study drug.]
  • Pharmacokinetics of CAR-T cells generated (Tmax). [Time frame: Up to two years after infusion with study drug.]
  • Pharmacokinetics of CAR-T cells generated Area Under the Curve (AUC) [Time frame: Up to two years after infusion with study drug.]
  • Assessment of Multiple Myeloma [Time frame: From dosing until disease progression or up to 15 years from receiving study drug, whichever happens first.]

Eligibility criteria

Inclusion criteria

  • Participants must have relapsed and refractory multiple myeloma (RRMM) with measurable disease
  • Participants must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and CD38-directed monoclonal antibody
  • Participants must have an Eastern Cooperative Group (ECOG) performance status of 0-1
  • Participants must have acceptable laboratory values as defined by the protocol

Exclusion criteria

  • Participants must not have known central nervous system (CNS) involvement with myeloma
  • Participants cannot have plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, or primary light chain amyloidosis
  • Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy
  • Participants cannot require systemic steroids for any condition

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • City of Hope — Duarte
  • Stanford University — Palo Alto
  • UCSF — San Francisco
  • Moffitt Cancer Center — Tampa
  • Emory University Hospital — Atlanta
  • Massachusetts General Hospital — Boston
  • Providence Portland Medical Center — Portland
Australia · 3 centers
  • The Royal Prince Alfred — Camperdown
  • Peter MacCallum Cancer Centre — Melbourne
  • The Alfred Paula Fox Melanoma and Cancer Centre — Melbourne

Identifiers

NCT: NCT07075185 · KLN-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗