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Solid TumorPhase 1NCT03970382

A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors

A Phase 1 study testing NeoTCR-P1 adoptive cell therapy, nivolumab and IL-2 in people with Solid Tumor, run by PACT Pharma, Inc. at 9 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This is a first in human, single arm, open label, Phase 1a/1b study to determine the safety, feasibility, and efficacy of a single dose of NeoTCR-P1 T cells in participants with solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
NeoTCR-P1 adoptive cell therapy, nivolumab and IL-2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
9 sitesUnited States
Study dates
3 Jul 2019to 12 Aug 2022
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

  • Histologically or cytologically documented incurable or metastatic solid tumors of the following types: melanoma, UC, ovarian cancer, colorectal cancer, breast cancer (HR+), or prostate cancer.
  • Disease has progressed after at least one available standard therapy or no additional curative therapies are available.
  • Measurable disease per RECIST v1.1
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  • Adequate hematologic and end organ function determined within 30 days prior to enrollment.
  • Disease-specific criteria related to the specific tumor type are required.
  • Note: There are additional inclusion criteria. The study center will determine if you meet all of the criteria.

Who cannot join

  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and/or inherited liver disease
  • Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
  • Uncontrolled or symptomatic hypercalcemia
  • Pregnancy, lactation, or breastfeeding
  • Prior allogeneic stem cell transplant or solid organ transplant
  • Prior chimeric antigen receptor therapy or other genetically modified T cell therapy
Show all 11Show fewer
  • Active HIV, Hepatitis B, or Hepatitis C infection
  • Active tuberculosis
  • Severe infection within 2 weeks prior to enrollment
  • Major surgical procedure within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the study.
  • Note: There are additional exclusion criteria. The study center will determine if you meet all of the criteria.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Northwestern University Medical Center

    Chicago, Illinois, 60611

  • City of Hope

    Duarte, California, 91010

  • University of California, Los Angeles

    Los Angeles, California, 90024

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of California, Irvine Medical Center

    Orange, California, 92868

  • University of California, Davis

    Sacramento, California, 95817

  • University of California, San Francisco

    San Francisco, California, 94158

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors

This is a first in human, single arm, open label, Phase 1a/1b study to determine the safety, feasibility, and efficacy of a single dose of NeoTCR-P1 T cells in participants with solid tumors.

Conditions
Solid Tumor
Being tested
NeoTCR-P1 adoptive cell therapy, nivolumab, IL-2
Keywords
melanoma, HR+ breast cancer, ovarian cancer, prostate cancer, colorectal cancer, urothelial carcinoma, adoptive cell therapy, neoantigen, T cell receptor, T lymphocyte, TCR-engineered T cells, personalized cell therapy, cell therapy, immunotherapy, gene therapy, PD-1, non-small cell lung cancer, head and neck squamous carcinoma, HER2 negative breast cancer, triple negative breast cancer
Medical subject headings
Melanoma, Ovarian Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeoTCR-P1 adoptive cell therapyBiological

    The investigational agent in this protocol is NeoTCR P1, an autologous adoptive T cell therapy (ACT) for patients with solid cancer. NeoTCR P1 is composed of apheresis derived CD8 and CD4 T cells that are precision genome engineered to express one autologous TCR of native sequence that targets a neoepitope (neoE) presented by human leukocyte antigen (HLA) receptors exclusively on the surface of that patient's tumor cells and not on other cells in the body.

  • nivolumabBiological

    Also called Opdivo

    Nivolumab is a human IgG4 anti-PD-1 monoclonal antibody

  • IL-2Biological

    Also called Proleukin, aldesleukin, interleukin-2

    IL-2 is a biologic response modifier. It is a type of protein called a cytokine.

Study groups in NCT03970382
Study groupRoleWhat they receive
NeoTCR-P1ExperimentalSingle dose of NeoTCR-P1
Receives: Biological: NeoTCR-P1 adoptive cell therapy
NeoTCR-P1 plus nivolumabExperimentalSingle dose of NeoTCR-P1 plus nivolumab 480mg IV every four weeks for up to 6 doses.
Receives: Biological: NeoTCR-P1 adoptive cell therapy; Biological: nivolumab
NeoTCR-P1 plus IL-2ExperimentalSingle dose of NeoTCR-P1 plus IL-2 500,000 IU/m2 SC twice daily (BID) for 7 days.
Receives: Biological: NeoTCR-P1 adoptive cell therapy; Biological: IL-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events as defined as DLTs

    Dose limiting toxicity (DLT) is defined as protocol-defined adverse events that occur within 28 days following infusion of Neo-TCR-P1 administered as a single agent without or with IL-2, or in combination with nivolumab.

    Measured: 28 days

  2. Number of participants with adverse events as a measure of safety and tolerability of NeoTCR-P1 or NeoTCR-P1 in combination with nivolumab

    Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Cytokine release syndrome (CRS) and neurotoxicity associated with NeoTCR-P1 will be graded according to ASBMT consensus grading.

    Measured: 2 years

  3. Maximum Tolerated Dose (MTD) of NeoTCR-P1

    The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level.

    Measured: 2 years

  4. Feasibility of manufacturing NeoTCR-P1

    Percent of screened patients that enroll on study and receive NeoTCR-P1

    Measured: 2 years

Secondary outcomes (7)

  1. Maximum concentration of NeoTCR-P1 (Cmax) in the peripheral blood

    Measured: 2 years

  2. Area-under-the-concentration-vs-time-curve (AUC) in the peripheral blood

    Measured: 28 days

  3. Persistence of NeoTCR-P1 in samples of peripheral blood

    Measured: 2 years

  4. Objective Response Rate (ORR) in participants with solid tumors following infusion of NeoTCR-P1 as a single agent or in combination with nivolumab

    ORR will be defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1, as determined by the investigator

    Measured: 2 years

  5. Duration of Response mediated by neoTCR-P1 administered as a single agent or in combination with nivolumab to participants with solid tumors

    Duration of response, defined as time from the first occurrence of a documented objective response to the time of relapse or death from any cause

    Measured: 2 years

  6. Progression free survival (PFS) in participants with solid tumors following infusion of NeoTCR-P1 as a single agent or in combination with nivolumab

    PFS is defined from date of administration of NeoTCR-P1 cell infusion to the date of disease progression per the RECIST v1.1 or death as a result of any cause. Subjects who do not meet criteria for progression by the analysis data cut-off date will be censored at their last evaluable disease assessment date

    Measured: 2 years

  7. Overall survival (OS) in participants with solid tumors following infusion of NeoTCR-P1 as a single agent or in combination with nivolumab

    OS will be measured from the date of administration of NeoTCR-P1 to the date of death. Subjects who have not died by the analysis data cut-off date will be censored at their last date of contact.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2019
  2. Study start3 Jul 2019
  3. Primary completion12 Aug 2022 (estimated)
  4. Study completion12 Aug 2022 (estimated)

Why it stopped: Business decision

Resources

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03970382
Sponsor's protocol ID
PACT-0101
Status last verified
Aug 2022
First submitted
6 May 2019
Last updated
18 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Foy SP, Jacoby K, Bota DA, Hunter T, Pan Z, Stawiski E, Ma Y, Lu W, Peng S, Wang CL, Yuen B, Dalmas O, Heeringa K, Sennino B, Conroy A, Bethune MT, Mende I, White W, Kukreja M, Gunturu S, Humphrey E, Hussaini A, An D, Litterman AJ, Quach BB, Ng AHC, Lu Y, Smith C, Campbell KM, Anaya D, Skrdlant L, Huang EY, Mendoza V, Mathur J, Dengler L, Purandare B, Moot R, Yi MC, Funke R, Sibley A, Stallings-Schmitt T, Oh DY, Chmielowski B, Abedi M, Yuan Y, Sosman JA, Lee SM, Schoenfeld AJ, Baltimore D, Heath JR, Franzusoff A, Ribas A, Rao AV, Mandl SJ. Non-viral precision T cell receptor replacement for personalized cell therapy. Nature. 2023 Mar;615(7953):687-696. doi: 10.1038/s41586-022-05531-1. Epub 2022 Nov 10.

    PubMed 36356599

  • Levy PL, Gros A. Fast track to personalized TCR T cell therapies. Cancer Cell. 2022 May 9;40(5):447-449. doi: 10.1016/j.ccell.2022.04.013. Epub 2022 May 9.

    PubMed 35537408

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NeoTCR-P1 adoptive cell therapy, nivolumab and IL-2 in people with Solid Tumor, run by PACT Pharma, Inc. at 9 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 7 inclusion and 11 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: paused, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

Results are not available in the source record.

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?

Incidence of adverse events as defined as DLTs (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03970382, which also lists 2 linked publications.

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 18 Aug 2022.

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Clinical Trial NCT03970382 | AzTrials