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CAR T-cell Therapy

PBCAR20A for Non-Hodgkin's Lymphoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Precision BioSciences, Inc.
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 1 year
Awards & highlights

Summary

This trial is testing a new drug for safety and activity in treating certain types of non-Hodgkin's lymphoma and chronic lymphocytic leukemia.

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Number of Participants With Dose-Limiting Toxicities
Secondary outcome measures
Objective Response Rate
Progression-free Survival (PFS)
Other outcome measures
Area Under the Curve [AUC]

Side effects data

From 2021 Phase 1 & 2 trial • 18 Patients • NCT04030195
75%
Neutrophil count decreased
75%
Anaemia
50%
Fatigue
50%
Pyrexia
38%
Nausea
38%
Oedema peripheral
38%
Platelet count decreased
38%
White blood cell count decreased
38%
Decreased appetite
38%
Hypokalaemia
25%
Aspartate aminotransferase increased
25%
Hypomagnesaemia
25%
Diarrhoea
25%
Dry mouth
25%
Blood alkaline phosphatase increased
25%
Somnolence
25%
Alanine aminotransferase increased
25%
Joint range of motion decreased
25%
Insomnia
25%
Pruritus
13%
Depression
13%
Pneumonia
13%
Sepsis
13%
Bone pain
13%
Bronchostenosis
13%
Tremor
13%
Cough
13%
Dyspnoea
13%
Pain in extremity
13%
Neutropenia
13%
Vomiting
13%
Human herpesvirus 6 infection
13%
Headache
13%
Encephalopathy
13%
Urinary incontinence
13%
Scrotal pain
13%
Abdominal pain
13%
Transaminases increased
13%
CAR T cell-related encephalopathy syndrome
13%
Tachycardia
13%
Abdominal distension
13%
Anal incontinence
13%
Constipation
13%
Gait disturbance
13%
Generalised oedema
13%
Peripheral swelling
13%
Cytokine release syndrome
13%
Escherichia bacteraemia
13%
Oral candidiasis
13%
Blood bilirubin increased
13%
Dehydration
13%
Hypocalcaemia
13%
Hypophosphataemia
13%
Arthralgia
13%
Back pain
13%
Muscle spasms
13%
Muscular weakness
13%
Neck pain
13%
CAR T-cell-related encephalopathy syndrome
13%
Dizziness
13%
Hypoaesthesia
13%
Lethargy
13%
Paraesthesia
13%
Confusional state
13%
Restlessness
13%
Urinary retention
13%
Scrotal oedema
13%
Hyperhidrosis
13%
Rash maculo-papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Level 1 of PBCAR20A CAR T Cells
Dose Level 2 of PBCAR20A CAR T Cells
Dose Level 3 of PBCAR20A CAR T Cells

Trial Design

3Treatment groups
Experimental Treatment
Group I: Dose Level 3 of PBCAR20A CAR T cellsExperimental Treatment3 Interventions
480 x 10\^6 CAR T cells (flat dose)
Group II: Dose Level 2 of PBCAR20A CAR T cellsExperimental Treatment3 Interventions
240 x 10\^6 CAR T cells (flat dose)
Group III: Dose Level 1 of PBCAR20A CAR T cellsExperimental Treatment3 Interventions
1 x 10\^6 chimeric antigen receptor (CAR) T cells per kg body weight. In this study, PBCAR20A, allogeneic anti-cluster of differentiation (CD20) CAR T Cells, is used to treat patients with relapsed or refractory (r/r) CD20+ Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Route of Administration: Intravenous infusion (IV) Lymphodepletion Conditioning: Lymphodepletion will be conducted several days prior to PBCAR20A infusion. A combination of fludarabine and cyclophosphamide will be used for lymphodepletion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2320
PBCAR20A
2020
Completed Phase 2
~20
Fludarabine
2012
Completed Phase 4
~1860

Find a Location

Who is running the clinical trial?

Precision BioSciences, Inc.Lead Sponsor
4 Previous Clinical Trials
265 Total Patients Enrolled
Monika Vainorius, MDStudy ChairPrecision BioSciences, Inc.
6 Previous Clinical Trials
534 Total Patients Enrolled
Alan List, MDStudy ChairPrecision BioSciences, Inc.
2 Previous Clinical Trials
88 Total Patients Enrolled
~3 spots leftby Sep 2025
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