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AzTrials

Prostate CancerPhase 1NCT03089203

CART-PSMA-TGFβRDN Cells for Castrate-Resistant Prostate Cancer

A Phase 1 study testing CART-PSMA-TGFβRDN cells, Cyclophosphamide and Fludarabine in people with Prostate Cancer, run by University of Pennsylvania at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a single center, single arm Phase I study to establish the safety and feasibility of intravenously administered lentivirally transduced dual PSMA-specific/TGFβ-resistant CAR modified autologous T cells (CART-PSMA-TGFβRDN cells) in patients with metastatic castrate resistant prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
CART-PSMA-TGFβRDN cells, Cyclophosphamide and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
8 Mar 2017to 8 Dec 2038
Phase
Phase 1
Are there results?
Not yet: the study is under way

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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Metastatic castrate resistant prostate cancer
  • RETIRED WITH PROTOCOL VERSION 15
  • Radiographic evidence of osseous metastatic disease and/or measurable, non-osseous metastatic disease (nodal or visceral)
  • Patients ≥ 18 years of age
  • ECOG performance status of 0 - 1
  • Adequate organ function, as defined by:
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  • Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 cc/min
  • Serum total bilirubin < 1.5x ULN
  • Serum ALT/AST < 2x ULN
  • Adequate hematologic reserve within 4 weeks of eligibility confirmation by physician-investigator as defined by:
  • Hgb > 10 g/dl
  • PLT > 100 k/ul
  • ANC > 1.5 k/ul Note: Subjects must not be transfusion dependent
  • Evidence of progressive castrate resistant prostate adenocarcinoma, as defined by:
  • Castrate levels of testosterone (< 50 ng/ml) with or without the use of androgen-deprivation therapy AND
  • Evidence of one of the following measures of progressive disease in the 12 weeks preceding eligibility confirmation by physician:
  • soft tissue progression by RECIST 1.1 criteria ii. osseous disease progression with 2 or more new lesions on bone scan (as per PCWG2 criteria) iii. increase in serum PSA of at least 25% and an absolute increase of 2 ng/ml or more from nadir (as per PCWG2 criteria)
  • Prior therapy with at least one standard initial therapy for the treatment of metastatic castrate resistant prostate cancer (i.e. docetaxel chemotherapy, 17α lyase inhibitor, or second-generation anti-androgen therapy)
  • Provides written informed consent
  • Subjects of reproductive potential must agree to use acceptable birth control methods

Who cannot join

  • RETIRED WITH PROTOCOL V16
  • History of an active non-curative non-prostate primary malignancy within the prior 3 years
  • RETIRED WITH PROTOCOL VERSION 6
  • Subjects who require the chronic use of systemic corticosteroid therapy. Patients may be on a low dose of steroids (≤10mg equivalent of prednisone).
  • RETIRED WITH PROTOCOL V13
  • Subjects with Class III/IV cardiovascular disability according to the New York Heart Association Classification
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  • Subjects with symptomatic vertebral metastases affecting spinal cord function (as determined by clinical history, physical exam, or MRI imaging)
  • Active autoimmune disease, including connective tissue disease, uveitis, inflammatory bowel disease, or multiple sclerosis; or a history of severe (as judged by the physician-investigator) autoimmune disease requiring prolonged immunosuppressive therapy
  • Patients with ongoing or active infection.
  • History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
  • Active hepatitis B, hepatitis C or HIV infection.
  • Active medical condition that, in the opinion of the physician-investigator, would substantially increase the risk of uncontrollable CRS or CAR Neurotoxicity.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Phase I Study of CART-PSMA-TGFβRDN Cells in Patients With Advanced Castrate Resistant Prostate Cancer

This is a single center, single arm Phase I study to establish the safety and feasibility of intravenously administered lentivirally transduced dual PSMA-specific/TGFβ-resistant CAR modified autologous T cells (CART-PSMA-TGFβRDN cells) in patients with metastatic castrate resistant prostate cancer.

Conditions
Prostate Cancer
Being tested
CART-PSMA-TGFβRDN cells, Cyclophosphamide, Fludarabine
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • CART-PSMA-TGFβRDN cellsBiological

    autologous CAR T cells

  • CyclophosphamideDrug

    300 mg/m2/day given over 3 days

  • FludarabineDrug

    30 mg/m2/day given over 3 days

Study groups in NCT03089203
Study groupRoleWhat they receive
Cohort 1ExperimentalCART-PSMA-TGFβRDN cells 1-3x10^7 Day 0
Receives: Biological: CART-PSMA-TGFβRDN cells
Cohort 2ExperimentalCART-PSMA-TGFβRDN cells 1-3x10^8 Day 0
Receives: Biological: CART-PSMA-TGFβRDN cells
Cohort -3ExperimentalCART-PSMA-TGFβRDN cells 1-3x10^7 Day 0
Receives: Biological: CART-PSMA-TGFβRDN cells; Drug: Cyclophosphamide; Drug: Fludarabine
Cohort 4ExperimentalCART-PSMA-TGFβRDN cells 0.70-1.00 x 10^8 Day 0
Receives: Biological: CART-PSMA-TGFβRDN cells; Drug: Cyclophosphamide; Drug: Fludarabine
Cohort 3ExperimentalCART-PSMA-TGFβRDN cells at the MTD (established by Cohorts 1-2) on day 0
Receives: Biological: CART-PSMA-TGFβRDN cells; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

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

  1. Occurrence of study related adverse events, laboratory toxicities and clinical events that are possibly, likely, or definitely related to study participation.

    using CTCAE v 4.03

    Measured: 15 years

  2. Clinical feasibility is defined as the frequency of subjects enrolled on this protocol who do not receive CART-PSMA-TGFβRDN cells.

    Measured: 30 days

  3. Manufacturing feasibility is determined by the frequency of product release failures and the occurrence of dose failures (inability to meet target dose).

    Measured: 30 days

Secondary outcomes (5)

  1. Assess the clinical anti-tumor effect of CART-PSMA-TGFβRDN cells by RECIST

    RECIST 1.1 criteria for soft tissue disease

    Measured: 6 months

  2. Assess the clinical anti-tumor effect of CART-PSMA-TGFβRDN cells by PCWG2

    PCWG2 criteria for osseous disease

    Measured: 6 months

  3. Assess the clinical anti-tumor effect of CART-PSMA-TGFβRDN cells by serum PSA measurement

    serum PSA measurement

    Measured: 6 months

  4. Assess the clinical anti-tumor effect of CART-PSMA-TGFβRDN cells by overal survival (OS).

    Measured: 15 Years

  5. Assess the clinical anti-tumor effect of CART-PSMA-TGFβRDN cells by number of subjects with progression free survival (PFS).

    Measured: 15 Years

Timeline

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

  1. First posted24 Mar 2017
  2. Study start8 Mar 2017
  3. Primary completion8 Sep 2038 (estimated)
  4. Study completion8 Dec 2038 (estimated)

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03089203
Sponsor's protocol ID
UPCC 32816, 826250
Status last verified
Feb 2026
First submitted
20 Mar 2017
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Narayan V, Barber-Rotenberg JS, Jung IY, Lacey SF, Rech AJ, Davis MM, Hwang WT, Lal P, Carpenter EL, Maude SL, Plesa G, Vapiwala N, Chew A, Moniak M, Sebro RA, Farwell MD, Marshall A, Gilmore J, Lledo L, Dengel K, Church SE, Hether TD, Xu J, Gohil M, Buckingham TH, Yee SS, Gonzalez VE, Kulikovskaya I, Chen F, Tian L, Tien K, Gladney W, Nobles CL, Raymond HE; Prostate Cancer Cellular Therapy Program Investigators; Hexner EO, Siegel DL, Bushman FD, June CH, Fraietta JA, Haas NB. PSMA-targeting TGFbeta-insensitive armored CAR T cells in metastatic castration-resistant prostate cancer: a phase 1 trial. Nat Med. 2022 Apr;28(4):724-734. doi: 10.1038/s41591-022-01726-1. Epub 2022 Mar 21.

    PubMed 35314843

  • Kloss CC, Lee J, Zhang A, Chen F, Melenhorst JJ, Lacey SF, Maus MV, Fraietta JA, Zhao Y, June CH. Dominant-Negative TGF-beta Receptor Enhances PSMA-Targeted Human CAR T Cell Proliferation And Augments Prostate Cancer Eradication. Mol Ther. 2018 Jul 5;26(7):1855-1866. doi: 10.1016/j.ymthe.2018.05.003. Epub 2018 May 8.

    PubMed 29807781

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CART-PSMA-TGFβRDN cells, Cyclophosphamide and Fludarabine in people with Prostate Cancer, run by University of Pennsylvania at 1 site 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 20 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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?

Occurrence of study related adverse events, laboratory toxicities and clinical events that are possibly, likely, or definitely related to study participation. (time frame: 15 years). The study lists 3 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 NCT03089203, 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 23 Feb 2026.

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