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Immunostimulant

Cohort 2: N-803 - IV 3 ug/kg for Multiple Myeloma

Phase 1
Waitlist Available
Research Sponsored by Altor BioScience
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up starts at week 11 - 12 and week 23 - 24
Awards & highlights
No Placebo-Only Group

Summary

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

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~starts at week 11 - 12 and week 23 - 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and starts at week 11 - 12 and week 23 - 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Response Rate of Treated Patients
Number of Participants With Treatment Emergent Adverse Events
Secondary study objectives
Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Clearance (CL/F)
Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Volume of Distribution (Vz/F)
Characterization of the Pharmacokinetic Profile - Area Under the Plasma Concentration Curve
+6 more

Side effects data

From 2024 Phase 2 trial • 32 Patients • NCT04491955
100%
Injection site reaction
92%
Flu like symptoms
42%
Anemia
42%
Abdominal pain
42%
Aspartate aminotransferase increased
42%
Fatigue
42%
Rash acneiform
33%
Alanine aminotransferase increased
33%
Fever
33%
Pruritus
25%
Disease progression
25%
Alkaline phosphatase increased
25%
Dyspnea
25%
Urinary tract infection
17%
Back pain
17%
Dysuria
17%
Chills
17%
Constipation
17%
Proteinuria
17%
Epistaxis
17%
Hyperglycemia
17%
Nausea
17%
Pain in extremity
17%
Vomiting
8%
Lung infection
8%
General disorders and administration site conditions - Other, specify
8%
Hematuria
8%
Lethargy
8%
Cardiac troponin I increased
8%
Sepsis
8%
Adrenal insufficiency
8%
Edema face
8%
Blood bilirubin increased
8%
Cough
8%
Dry skin
8%
Gastric ulcer
8%
General disorders and administration site conditions - Other, Mucosal bleeding
8%
Hot flashes
8%
Hypokalemia
8%
Hypophosphatemia
8%
Infusion related reaction
8%
Mucositis oral
8%
Myalgia
8%
Oral hemorrhage
8%
Papulopustular rash
8%
Paresthesia
8%
Skin hyperpigmentation
8%
Thrush
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241)
Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation
Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation
Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Cohort 6: N-803 - SQ 15 ug/kgExperimental Treatment1 Intervention
Group II: Cohort 5: N-803 - SQ 10 ug/kgExperimental Treatment1 Intervention
Group III: Cohort 4: N-803 - IV 10 ug/kgExperimental Treatment1 Intervention
Group IV: Cohort 3: N-803 - IV 6 ug/kgExperimental Treatment1 Intervention
Group V: Cohort 2: N-803 - IV 3 ug/kgExperimental Treatment1 Intervention
Group VI: Cohort 1: N-803 - IV 1 ug/kgExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-803
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,434 Total Patients Enrolled
594 Trials studying Multiple Myeloma
191,032 Patients Enrolled for Multiple Myeloma
Altor BioScienceLead Sponsor
17 Previous Clinical Trials
502 Total Patients Enrolled
2 Trials studying Multiple Myeloma
6 Patients Enrolled for Multiple Myeloma
Hing C Wong, PhDStudy ChairAltor BioScience
5 Previous Clinical Trials
236 Total Patients Enrolled
1 Trials studying Multiple Myeloma
6 Patients Enrolled for Multiple Myeloma
~2 spots leftby Nov 2025
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