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CAR T-cell Therapy

QUILT-3.020: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma

Phase 1 & 2
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 3 years
Awards & highlights
No Placebo-Only Group

Summary

This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801 in patients who have relapsed or refractory multiple myeloma.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Treatment-Related Adverse Events
Secondary study objectives
Clinical Benefit
Duration of Response
Immunogenicity and Pharmacokinetics
+2 more

Side effects data

From 2016 Phase 1 & 2 trial • 68 Patients • NCT01326871
100%
Platelet count decreased
100%
Nausea
100%
Vomiting
100%
Neutrophil count decreased
100%
Pruritus
100%
Rash maculo-papular
67%
Pyrexia
67%
Fatigue
67%
Constipation
67%
White blood cell count decreased
67%
Anaemia
67%
Dry skin
33%
Pain
33%
Aspartate aminotransferase increased
33%
Blood alkaline phosphatase increased
33%
Chills
33%
Oedema peripheral
33%
Influenza like illness
33%
Dyspepsia
33%
Alanine aminotransferase increased
33%
Weight increased
33%
Hyponatraemia
33%
Hypophosphataemia
33%
Lymphocyte count decreased
33%
Decreased appetite
33%
Hypoalbuminaemia
33%
Hypocalcaemia
33%
Alopecia
33%
Cough
33%
Rhinitis allergic
33%
Headache
33%
Hypotension
33%
Skin infection
33%
Cystitis
33%
Fall
33%
Contusion
33%
Vision blurred
100%
80%
60%
40%
20%
0%
Study treatment Arm
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
ALT-801 0.06 mg/kg With Gemcitabine

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: ALT-801 0.06mg/kgExperimental Treatment1 Intervention
Group II: ALT-801 0.04mg/kgExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALT-801
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Altor BioScienceLead Sponsor
17 Previous Clinical Trials
515 Total Patients Enrolled
2 Trials studying Multiple Myeloma
19 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,574 Total Patients Enrolled
594 Trials studying Multiple Myeloma
191,411 Patients Enrolled for Multiple Myeloma
Hing C Wong, PhDStudy ChairAltor BioScience
5 Previous Clinical Trials
249 Total Patients Enrolled
1 Trials studying Multiple Myeloma
19 Patients Enrolled for Multiple Myeloma
~0 spots leftby Dec 2025
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