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Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles

ALT-803

Hing C Wong, PhD

This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation study of ALT-803 in patients with relapsed or refractory multiple myeloma.

The purpose of this study is to evaluate the safety, determine the Maximum Tolerated Dose (MTD) or the Minimum Efficacious Dose (MED) and characterize the immunogenicity and pharmacokinetic profile of ALT-803 in treated patients. The effect of ALT-803 on the peripheral absolute lymphocyte counts and white blood cell counts, the number and phenotype of peripheral blood T (total and subsets) and NK cells will be evaluated. The anti-tumor responses of ALT-803 will also be assessed in this trial.

QUILT-3.005: A Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma

A Phase I/II Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma

For phase I \& II

Number and severity of treatment related AEs that occur or worsen after the first dose of study treatment.

For phase I only

Determine the maximum tolerated dose (MTD) level or minimum efficacious dose (MED) and designate the dose level for phase II.

For phase I and II

Number of participants with an objective response, which includes, a complete response, a partial response or a stable disease.

For phase Ib and II

Evaluation of the effect of ALT-803 on the peripheral ALC and WBC counts, the number and phenotype of peripheral blood T (total and subsets) and NK cells in treated patients.

For phase I and II

Area under the plasma concentration-time curve from time zero to infinity (AUC) and the half-life of ALT-803.

For phase I and II

Measures the serum levels of IL-2, IL-4, IL-6, IL-10, IFN-gamma, MCP-1 and TNF-alpha in treated patients.

For Phase I and II

Measures the anti-ALT-803 neutralizing effects.

All enrolled patients will be assessed every 3 months during year 1 and then every 6 months during years 2 and 3 from the start of study treatment to determine their overall survival, progression-free survival and duration of response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
QUILT-3.005: A Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma	NCT02099539	Relapsed or Ref...	ALT-803	18 Years -	Altor BioScience
QUILT-3.005: A Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma	NCT02099539	Relapsed or Ref...	ALT-803	18 Years -	Altor BioScience
QUILT-3.005: A Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma	NCT02099539	Relapsed or Ref...	ALT-803	18 Years -	Altor BioScience

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