Supercharged immune cells take on Hard-to-Treat prostate cancer
NCT ID NCT03089203
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests a new type of immunotherapy for men with advanced prostate cancer that no longer responds to hormone therapy. The treatment uses the patient's own immune cells, which are genetically modified to better recognize and attack prostate cancer cells while resisting signals that normally shut them down. The main goal is to see if this approach is safe and feasible in 23 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- engineered immune cells (CART-PSMA-TGFβRDN cells)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced prostate cancer that is resistant to standard hormone therapy.
- What could go wrong
- This is a very early phase 1 trial with only 23 participants, so it is primarily checking safety. The treatment may not shrink tumors or improve survival, and there are risks of serious side effects from the cell infusion and chemotherapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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23 people
The number who actually took part.
- Started
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Mar 2017
- Expected to finish
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Dec 2038
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Metastatic castrate resistant prostate cancer 2. RETIRED WITH PROTOCOL VERSION 15 3. Radiographic evidence of osseous metastatic disease and/or measurable, non-osseous metastatic disease (nodal or visceral) 4. Patients ≥ 18 years of age 5. ECOG performance status of 0 - 1 6. Adequate organ function, as defined by: 1. Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 cc/min 2. Serum total bilirubin \< 1.5x ULN 3. Serum ALT/AST \< 2x ULN 7. Adequate hematologic reserve within 4 weeks of eligibility confirmation by physician-investigator as defined by: 1. Hgb \> 10 g/dl 2. PLT \> 100 k/ul 3. ANC \> 1.5 k/ul Note: Subjects must not be transfusion dependent 8. Evidence of progressive castrate resistant prostate adenocarcinoma, as defined by: 1. Castrate levels of testosterone (\< 50 ng/ml) with or without the use of androgen-deprivation therapy AND 2. Evidence of one of the following measures of progressive disease in the 12 weeks preceding eligibility confirmation by physician: i. 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) 9. 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) 10. Provides written informed consent 11. Subjects of reproductive potential must agree to use acceptable birth control methods Exclusion Criteria: 1. RETIRED WITH PROTOCOL V16 2. History of an active non-curative non-prostate primary malignancy within the prior 3 years 3. RETIRED WITH PROTOCOL VERSION 6 4. Subjects who require the chronic use of systemic corticosteroid therapy. Patients may be on a low dose of steroids (≤10mg equivalent of prednisone). 5. RETIRED WITH PROTOCOL V13 6. Subjects with Class III/IV cardiovascular disability according to the New York Heart Association Classification 7. Subjects with symptomatic vertebral metastases affecting spinal cord function (as determined by clinical history, physical exam, or MRI imaging) 8. 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 9. Patients with ongoing or active infection. 10. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40) 11. Active hepatitis B, hepatitis C or HIV infection. 12. Active medical condition that, in the opinion of the physician-investigator, would substantially increase the risk of uncontrollable CRS or CAR Neurotoxicity.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
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- A scanner in the operating room could show surgeons exactly where prostate cancer remains