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

A Phase 1 Study of PBCAR19B in Participants With CD19-expressing Malignancies

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04649112

Enrollment

Registered

2020-12-02

Start date

2021-06-16

Completion date

2023-09-30

Last updated

2024-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CD19 Expressing Malignancies, Hematologic Malignancy

Brief summary

This is a Phase 1, nonrandomized, open-label, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR19B in adult study participants with CD-19 expressing malignancies.

Interventions

GENETICPBCAR19B

Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Relapsed or refractory CD19+ expressing malignancies * At least 2 prior regimens per Standard of Care

Exclusion criteria

* No history of active CNS involvement

Design outcomes

Primary

Measure	Time frame	Description
Maximum Tolerated Dose (MTD)	Day 1 - Day 28	To determine the maximum tolerated dose (MTD)
Number of participants with Dose Limiting Toxicity(ies)	1 year	To assess adverse events as dose limiting toxicities as defined by the protocol and CTCAE v5.0.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026