NCT04649112

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

Completed Phase 1 Last updated 26 July 2024

What this trial tests

Phase 1 trial testing PBCAR19B in CD19 Expressing Malignancies in 13 participants. Completed in 30 September 2023.

Timeline

16 June 2021

Primary endpoint
22 December 2022

30 September 2023

Quick facts

Lead sponsor	Precision BioSciences, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	16 June 2021
Primary completion	22 December 2022
Estimated completion	30 September 2023
Sites	7 locations across United States

Drugs / interventions tested

• PBCAR19B

Conditions studied

• CD19 Expressing Malignancies — all drugs for CD19 Expressing Malignancies →
• Hematologic Malignancy — all drugs for Hematologic Malignancy →

Sponsor

Precision BioSciences, Inc. — full company profile →

Who can join

18 and older, any sex, with CD19 Expressing Malignancies or Hematologic Malignancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Allogeneic CAR-T Therapy Technologies: Has the Promise Been Met?
   Lonez C, Breman E. · · 2024 · cited 57× · PMID 38247837 · DOI 10.3390/cells13020146
2. Genome-edited allogeneic donor "universal" chimeric antigen receptor T cells.
   Qasim W. · · 2023 · cited 48× · PMID 36223560 · DOI 10.1182/blood.2022016204
3. Recent updates on allogeneic CAR-T cells in hematological malignancies.
   Mansoori S, Noei A, Maali A, Seyed-Motahari SS, et al · · 2024 · cited 34× · PMID 39227937 · DOI 10.1186/s12935-024-03479-y
4. Engineering strategies to safely drive CAR T-cells into the future.
   Rossi M, Breman E. · · 2024 · cited 25× · PMID 38962002 · DOI 10.3389/fimmu.2024.1411393
5. Progress and pitfalls of gene editing technology in CAR-T cell therapy: a state-of-the-art review.
   Moradi V, Khodabandehloo E, Alidadi M, Omidkhoda A, et al · · 2024 · cited 24× · PMID 38912057 · DOI 10.3389/fonc.2024.1388475
6. Advances in Allogeneic Cancer Cell Therapy and Future Perspectives on "Off-the-Shelf" T Cell Therapy Using iPSC Technology and Gene Editing.
   Furukawa Y, Hamano Y, Shirane S, Kinoshita S, et al · · 2022 · cited 23× · PMID 35053386 · DOI 10.3390/cells11020269
7. Gene editing to enhance the efficacy of cancer cell therapies.
   Murty T, Mackall CL. · · 2021 · cited 16× · PMID 34673274 · DOI 10.1016/j.ymthe.2021.10.001
8. Allogeneic CAR-engineered cellular therapy for relapsed and refractory large B cell lymphoma: a systematic review and meta-analysis.
   Biederstädt A, Bassermann F, Hecker JS. · · 2025 · cited 6× · PMID 40698082 · DOI 10.3389/fimmu.2025.1585556