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

ConditionsMultiple Myeloma in RelapseMyeloma MultipleMultiple Myeloma ProgressionNeoplasms by Histologic TypeNeoplasmHemostatic DisordersVascular DisorderParaproteinemiasBlood Protein DisordersHematologic Disease and DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseaseGene Therapy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKelonia Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • KLN-1010

    Drug

    Given at specified dose one time

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: KLN-1010Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs), and/or establish the recommended Phase 2 Dose

All adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) or American Society for Transplantation and Cell Therapy (ASTCT) criteria

Time frame
Up to 15 years from dosing of KLN-1010

Secondary outcomes

1

Pharmacokinetics of KLN-1010 after dosing.

Peak of virus vector genomes (Cmax of lentivirus) in blood.

Time frame
Up to two years after dosing with study drug.
2

Pharmacokinetics of KLN-1010 (Tmax).

Measurement of time to the highest amount of viral vector in the blood.

Time frame
Up to two years after infusion with study drug.
3

Pharmacokinetics of KLN-1010 Area Under the Curve (AUC)

Measurement of the amount of viral vector (AUC of lentivirus) in blood over time.

Time frame
Up to two years after infusion with study drug.
4

Pharmacokinetics of CAR-T cells generated.

The presence and number of CAR-T (Cmax) cells present in blood.

Time frame
Up to two years after infusion with study drug.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kelonia Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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