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CAR T-cell Therapy

PBCAR19B for Malignancies

Phase 1

Recruiting

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

Study Summary

This trial is testing a new drug to see if it's safe and effective in treating adults with cancer that has spread.

Eligible Conditions

CD19 Expressing Malignancies
Blood Cancers

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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 Toxicity(ies)

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Level 3Experimental Treatment1 Intervention

In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion.

Group II: Dose Level 2Experimental Treatment1 Intervention

Group III: Dose Level 1Experimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Precision BioSciences, Inc.Lead Sponsor

4 Previous Clinical Trials

261 Total Patients Enrolled

Monika Vainorius, MDStudy ChairPrecision BioSciences, Inc.

5 Previous Clinical Trials

409 Total Patients Enrolled

Media Library

PBCAR19B (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04649112 — Phase 1

Malignancies Research Study Groups: Dose Level 1, Dose Level 2, Dose Level 3

Malignancies Clinical Trial 2023: PBCAR19B Highlights & Side Effects. Trial Name: NCT04649112 — Phase 1

PBCAR19B (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04649112 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are participating in this trial's execution?

"This medical trial is taking place at Moffitt Cancer Center in Tampa, Florida; Columbia University in New york City ; and Lifespan Cancer Institute at Rhode island Hospital located in Providence. Additionally, there are 7 additional sites where the study can be accessed."

Answered by AI

Are there any available openings in this trial for participants?

"According to clinicaltrials.gov, this research endeavor is currently looking for participants and has been open since June 16th 2021, the most recent update being on November 8th 2022."

Answered by AI

Has the Food and Drug Administration approved PBCAR19B for general use?

"There is minimal evidence of safety and efficacy for PBCAR19B, hence our team at Power ranked it a 1 on the scale."

Answered by AI

What is the participant capacity for this clinical investigation?

"For this medical trial to be successful, it needs 24 patients that meet the criteria for inclusion. Patients can choose between Moffitt Cancer Center in Tampa, Florida and Columbia University in New york City as a participating research site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies

2021. "Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04649112.