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CAR T-cell Therapy

CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg) for Non-Hodgkin's Lymphoma

Phase 1
Waitlist Available
Led By Nirav Shah, MD
Research Sponsored by Medical College of Wisconsin
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 28 days after infusion
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that uses a person's own T cells that have been engineered to target and kill CD19 or CD20 positive B cell malignancies.

Eligible Conditions
  • Non-Hodgkin's Lymphoma
  • B-Cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days after infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days after infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Adverse Events After CAR 20/19-T Cell Infusion

Side effects data

From 2021 Phase 1 trial • 26 Patients • NCT03019055
100%
Lymphocyte count decreased
100%
White blood cell decreased
100%
Neutrophil count decreased
88%
Anemia
81%
Cytokine release syndrome
81%
Hypocalcemia
81%
Platelet count decreased
75%
Fatigue
69%
Nausea
69%
Diarrhea
63%
Sinus tachycardia
63%
Hypoalbuminemia
56%
Hyperglycemia
56%
Hyponatremia
56%
Aspartate aminotransferase increased
50%
Hypertension
50%
Headache
50%
Creatinine increased
44%
Hypotension
44%
Hypokalemia
44%
Alanine aminotransferase increased
38%
Activated partial thromboplastin time prolonged
38%
Dizziness
38%
Constipation
38%
Alkaline phosphatase increased
31%
Cough
25%
Hypoxia
25%
Sore throat
25%
Fever
25%
Edema limbs
25%
Anorexia
25%
Psychiatric disorders - Other, specify
25%
Hypophosphatemia
19%
Hematuria
19%
Arthralgia
19%
Stomach pain
19%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
19%
Urinary incontinence
19%
Vomiting
19%
Infections and infestations - Other, specify
19%
Urinary tract infection
19%
Lung infection
19%
Vascular access complication
19%
Blood bilirubin increased
19%
Hypernatremia
19%
Confusion
19%
Delirium
19%
Acute kidney injury
19%
Sinus bradycardia
13%
Neck pain
13%
Hypertriglyceridemia
13%
Atrial fibrillation
13%
Proteinuria
13%
Dyspnea
13%
Disseminated intravascular coagulation
13%
Fecal incontinence
13%
Dysphagia
13%
Hyperkalemia
13%
Blood and lymphatic system disorders - Other, specify
13%
Flank pain
13%
Abdominal distension
13%
Abdominal pain
13%
Bloating
13%
Chills
13%
Infusion related reaction
13%
Fibrinogen decreased
13%
Hypercalcemia
13%
Hypomagnesemia
13%
Generalized muscle weakness
13%
Syncope
13%
Anxiety
13%
Respiratory, thoracic and mediastinal disorders - Other, specify
13%
Hyperhidrosis
13%
Rash maculo-papular
6%
Productive cough
6%
Watering eyes
6%
Ear pain
6%
Blurred vision
6%
Urinary frequency
6%
Dehydration
6%
Pain in extremity
6%
Urinary tract pain
6%
Thromboembolic event
6%
Febrile neutropenia
6%
Flu like symptoms
6%
Hypermagnesemia
6%
Urinary retention
6%
Back pain
6%
Myalgia
6%
Facial pain
6%
Movements involuntary
6%
Tremor
6%
Vasovagal reaction
6%
Multi-organ failure
6%
Lymphocyte count increased
6%
Leukocytosis
6%
Eye pain
6%
Floaters
6%
Pain
6%
Non-cardiac chest pain
6%
Infusion site extravasation
6%
Sepsis
6%
Upper respiratory infection
6%
Enterocolitis infectious
6%
Fracture
6%
Dysphasia
6%
Lethargy
6%
Presyncope
6%
Somnolence
6%
Allergic rhinitis
6%
Apnea
6%
Aspiration
6%
Atelectasis
6%
Wheezing
6%
Pruritus
6%
Skin and subcutaneous tissue disorders - Other, specify
6%
Tinnitus
6%
Dry eye
6%
Weight loss
6%
Hypoglycemia
6%
Hallucinations
6%
Genital edema
6%
Gastroesophageal reflux disease
6%
Hyperuricemia
6%
Malaise
6%
Facial muscle weakness
6%
Agitation
100%
80%
60%
40%
20%
0%
Study treatment Arm
CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)
CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg)
CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg)
CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg)

Trial Design

4Treatment groups
Experimental Treatment
Group I: CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg)Experimental Treatment1 Intervention
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
Group II: CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)Experimental Treatment1 Intervention
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
Group III: CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg)Experimental Treatment1 Intervention
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
Group IV: CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg)Experimental Treatment1 Intervention
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg)
2017
Completed Phase 1
~30
CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg)
2017
Completed Phase 1
~30
CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg)
2017
Completed Phase 1
~30
CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)
2017
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
608 Previous Clinical Trials
1,162,475 Total Patients Enrolled
Children's Hospital and Health System Foundation, WisconsinOTHER
55 Previous Clinical Trials
96,623 Total Patients Enrolled
Nirav Shah, MDPrincipal InvestigatorMedical College of Wisconsin
4 Previous Clinical Trials
162 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell
Nirav Shah 2017. "Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03019055.
~3 spots leftby Apr 2025
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