CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
PBCAR20A +2 moregenetic
Likely dose
Fludarabine 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04030195
NCT04030195Phase 2Completed
CompareCT.gov

A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR20A in Subjects With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Precision BioSciences, Inc.·interventional·Posted Jul 23, 2019·Updated Jan 31, 2023

In Brief

A Phase 2 clinical trial evaluating PBCAR20A, Fludarabine, and 1 other intervention for Non-Hodgkin's Lymphoma, Relapsed and 8 related conditions. Completed, enrolled 18 participants across 5 sites.

Detailed Summary

This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR20A in adult subjects with r/r B-cell NHL or r/r CLL/SLL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma, Relapsed, Chronic Lymphoid Leukemia in Relapse, Non-Hodgkin's Lymphoma Refractory, Chronic Lymphocytic Leukemia, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-cell Chronic Lymphocytic Leukemia, B-cell Non Hodgkin Lymphoma, Small Lymphocytic Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 23, 2019
Enrollment StartMar 24, 2020
Primary CompletionJun 24, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.9 years ago

Interventions

PBCAR20Agenetic

Single dose of Allogeneic Anti-CD20 CAR T cells will be infused, and a classic "3+3" dose escalation will be applied.

Fludarabinedrug

Fludarabine is used for lymphodepletion (30 mg/m\^2/day, Days -5 to -3).

Cyclophosphamidedrug

Cyclophosphamide is used for lymphodepletion (500 mg/m\^2/day, Days -5 to -3).