CD19 Expressing MalignanciesPhase 1NCT04649112
Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies
A Phase 1 study testing PBCAR19B in people with CD19 Expressing Malignancies and Hematologic Malignancy, run by Precision BioSciences, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CD19 Expressing Malignancies, Hematologic Malignancy
- What is being tested?
- PBCAR19B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Jun 2021to 30 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory CD19+ expressing malignancies
- At least 2 prior regimens per Standard of Care
Who cannot join
- No history of active CNS involvement
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Tufts Medical Center
Boston, Massachusetts, 02111
City of Hope
Duarte, California, 91010
Banner MDA
Gilbert, Arizona, 85234
Columbia University
New York, New York, 10032
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Lifespan Cancer Institute at Rhode Island Hospital
Providence, Rhode Island, 02903
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase 1 Study of PBCAR19B in Participants With CD19-expressing Malignancies
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.
- Being tested
- PBCAR19B
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBCAR19BGenetic
Also called Allogeneic Anti-CD19 CAR T cells
Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | 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. Receives: Genetic: PBCAR19B |
| Dose Level 2 | Experimental | 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. Receives: Genetic: PBCAR19B |
| Dose Level 3 | Experimental | 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. Receives: Genetic: PBCAR19B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
To determine the maximum tolerated dose (MTD)
Measured: Day 1 - Day 28
Number of participants with Dose Limiting Toxicity(ies)
To assess adverse events as dose limiting toxicities as defined by the protocol and CTCAE v5.0.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start16 Jun 2021
- Primary completion22 Dec 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD19 Expressing MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Precision BioSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monika Vainorius, MD, Study chair, Precision BioSciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649112
- Sponsor's protocol ID
- PBCAR19B-01
- Status last verified
- Jul 2024
- First submitted
- 24 Nov 2020
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of PBCAR19B in Participants With CD19-expressing Malignancies
- ClinicalTrials.gov ID
- NCT04649112
- Acronym / sponsor ID
- PBCAR19B-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Precision BioSciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Genetic: PBCAR19BIn 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. |
| Dose Level 2 | Experimental | Genetic: PBCAR19BIn 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. |
| Dose Level 3 | Experimental | Genetic: PBCAR19BIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Relapsed or refractory CD19+ expressing malignancies
- At least 2 prior regimens per Standard of Care
Key exclusion criteria (1 listed)
- No history of active CNS involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBCAR19BAlso: Allogeneic Anti-CD19 CAR T cellsSingle dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused | Genetic | Dose Level 1, Dose Level 2, Dose Level 3 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Day 1 - Day 28
To determine the maximum tolerated dose (MTD)
Number of participants with Dose Limiting Toxicity(ies)
Time frame: 1 year
To assess adverse events as dose limiting toxicities as defined by the protocol and CTCAE v5.0.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for CD19 Expressing Malignancies
RecruitingPhase 1/2
CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
B-NHL, B-Non Hodgkin Lymphoma
RecruitingPhase 2
CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, B-All
Active, not recruitingPhase 1
Activated T Lymphocytes Expressing CARs, Relapsed CD19+ Malignancies Post-Allo HSCT(CARPASCIO)
Non-Hodgkin's Lymphoma, B-Cell ALL
Active, not recruitingPhase 1
Multi-virus CTLs Expressing CD19 Chimeric Receptors, CD19 Positive Malignancies Post SCT, MULTIPRAT
Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL)
Active, not recruitingPhase 1
CD19 Chimeric Receptor Expressing T Lymphocytes In B-Cell Non Hodgkin's Lymphoma, ALL & CLL
B Cell Lymphoma, Chronic Lymphocytic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Vainorius, MD study chair
Precision BioSciences, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PBCAR19B in people with CD19 Expressing Malignancies and Hematologic Malignancy, run by Precision BioSciences, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: Day 1 - Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.