Metastatic Castrate-Resistant Prostate Cancer (mCRPC)Phase 1NCT06046040
TmPSMA-02 in mCRPC
A Phase 1 study testing TmPSMA-02 CAR T Cells in people with Metastatic Castrate-Resistant Prostate Cancer (mCRPC), run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a Phase I, open-label dose finding study to assess the safety, tolerability, manufacturing feasibility, and preliminary efficacy of TmPSMA-02 CAR T cells in patients with metastatic castrate-resistant prostate cancer (mCRPC). Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
- What is being tested?
- TmPSMA-02 CAR T Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2024to 31 Jan 2042
- 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
- Signed, written informed consent
- Adult participants ≥ 18 years of age
- Metastatic castrate-resistant prostate cancer (mCRPC)
- Castrate levels of testosterone (<50 ng/dL) with/without the use of androgen-deprivation therapy
- Received at least one prior standard therapy for systemic treatment in the mCRPC setting, including at least one second generation androgen receptor signaling inhibitor (e.g., enzalutamine, apalutamide, darolutamide, or abiraterone) or a taxane-based regimen (e.g., docetaxel, cabazitaxel, etc).
- Adequate organ function within 4 weeks of eligibility confirmation by a physician-investigator defined as:
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- Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 cc/min per the Cockcroft-Gault Equation; Patient must not be on dialysis
- ALT/AST ≤ 3 x ULN
- Serum total bilirubin ≤ 1.5 mg/dL, unless the subject has Gilbert's syndrome (if so, serum total bilirubin must be ≤3.0 mg/dL)
- Left Ventricle Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO
- Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen > 92% on room air
- Patients must have adequate hematologic reserve within 4 weeks of eligibility confirmation by a physician-investigator and must not be dependent on transfusions to maintain these hematologic parameters. Adequate hematologic reserve is defined as:
- Hemoglobin ≥ 8 g/dL
- Absolute neutrophil count ≥ 1000/μL
- Platelet count ≥ 75,000/μL
- ECOG Performance Status that is either 0 or 1.
- Patients who have not undergone bilateral orchiectomy must be able to continue GnRH therapy during the study.
- Participants of reproductive potential must agree to use acceptable birth control methods, as described in the protocol.
Who cannot join
- Active hepatitis B or hepatitis C infection
- Any other active, uncontrolled infection
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- Severe, active co-morbidity that in the opinion of the physician-investigator would preclude participation in the study.
- Active invasive cancer, other than the proposed cancer included in the study, within 2 years prior to eligibility confirmation by a physician-investigator. [Note: non-invasive cancers treated with curative intent (e.g., non-melanoma skin cancer) may still be eligible].
- Patients requiring chronic treatment systemic steroids or immunosuppressant medications. Low-dose physiologic replacement therapy with corticosteroids equivalent to prednisone 10 mg/day or lower, topical steroids and inhaled steroids are acceptable. For additional details regarding use of steroid and immunosuppressant medications, please see Section 5.6.
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- Prior treatment with autologous T-cell therapy, with the exception of Sipuleucel-T.
- Prior allogeneic stem cell transplant.
- Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
- History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase I, Open-Label Study of Dually Armored Chimeric Antigen Receptor (CAR) T Cells (TmPSMA-02) in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
This is a Phase I, open-label dose finding study to assess the safety, tolerability, manufacturing feasibility, and preliminary efficacy of TmPSMA-02 CAR T cells in patients with metastatic castrate-resistant prostate cancer (mCRPC). Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.
Read the detailed description
This is a Phase I, open-label dose finding study to assess the safety, tolerability, manufacturing feasibility, and preliminary efficacy of TmPSMA-02 CAR T cells in patients with metastatic castrate-resistant prostate cancer (mCRPC). Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design as described below. Dose escalation will begin with Dose Level 1 as follows:
- Dose Level 1 (N = 3 to 6): Subjects will receive a single dose of 5 x 107 TmPSMA-02 CAR T cells via IV infusion administration on Day 0, following lymphodepletion with fludarabine and cyclophosphamide. This dose level will be evaluated as follows:
- If 1 DLT/3 subjects occurs, the study will enroll an additional 3 subjects at this dose level.
- If 0 DLT/3 subjects or 1 DLT/6 subjects occur, the study will advance to Dose Level 2 (DL2).
- In the event that 2 or more DLTs occur at Dose Level 1 (DL1), enrollment at this dose level will be stopped and Dose Level -1 (DL-1) will be opened. In Dose Level -1, subjects will receive a de-escalated dose of 1 x 107 TmPSMA-02 CAR T cells following lymphodepletion.
If 0 DLT/3 or 1 DLT/3 subjects occurs at DL-1, the study will enroll an additional 3 subjects at this dose level.
If ≥ 2 DLTs occur at any time, enrollment at this dose level will be stopped.
Dose Level 2 (N = 3 to 6): Subjects will receive a single fixed dose of 1 x 108 TmPSMA-02 CAR T cells via IV infusion on Day 0, following lymphodepletion with fludarabine and cyclophosphamide. This dose level will be evaluated as follows:
- If 1 DLT/3 subjects occurs, the study will enroll an additional 3 subjects at this dose level.
- If 0 DLT/3 subjects or 1 DLT/6 subjects occur, the study will advance to Dose Level 3 (DL3).
- If 2 DLTs occur at any time, enrollment at this dose level will be stopped. If less than 6 subjects were treated at the previous dose level (DL1), additional subjects will be enrolled at that dose level to reach a minimum of 6 DLT-evaluable subjects for MTD determination.
- Dose Level 3 (N = 3 to 6): Subjects will receive a single fixed dose of 3 x 108 TmPSMA-02 CAR T cells via IV infusion Day 0, following lymphodepletion with fludarabine and cyclophosphamide. This dose level will be evaluated as follows:
- If 1 DLT/3 subjects occurs, the study will enroll an additional 3 subjects at this dose level.
- If 0 DLT/3 subjects occurs, the study will still enroll an additional 3 subjects at this dose level to allow for MTD determination.
- If 2 DLTs occur at any time, enrollment at this dose level will be stopped. If less than 6 subjects were treated at the previous dose level (DL2), additional subjects will be enrolled at that dose level to reach a minimum of 6 DLT-evaluable subjects for MTD determination.
The highest dose at which 0 or 1 DLT occurs in 6 DLT-evaluable subjects will be declared the MTD.
Retreatment Infusions:
The Retreatment Phase will remain closed until sufficient safety and persistence data is available in initial subjects, and DSMB and FDA approval to open Retreatment has been received.
Subjects who have demonstrated clinical benefit after their initial TmPSMA-02 CAR T cell infusion (e.g., minimum disease response of stable disease, etc.) may also be eligible to receive retreatment with TmPSMA-02 CAR T cells at the physician-investigator's discretion. The TmPSMA-02 retreatment dose administered must either be a) the CAR T cell dose that the subject previously received without DLTs, or b) a CAR T cell dose that is less than or equal to a dose level that has been evaluated for safety in ≥ 3 other subjects without evidence of DLTs. As retreatment infusions will not be used for formal DLT assessments/MTD determination, there are no protocol-defined staggering requirements.
- Being tested
- TmPSMA-02 CAR T Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TmPSMA-02 CAR T CellsDrug
TmPSMA-02 CAR T cells: autologous T cells transduced with a lentiviral vector to express an anti-PSMA CAR containing a humanized J591-derived scFv and CD2 co-stimulatory domain, and dually armored with a TGFβRDN and PD1.CD28 switch receptor.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level -1 | Experimental | After lymphodepleting chemotherapy subjects to receive 1x10(7) TmPSMA-02 CAR T Cells Receives: Drug: TmPSMA-02 CAR T Cells |
| Dose Level 1 | Experimental | After lymphodepleting chemotherapy subjects to receive 5 x10(7) TmPSMA-02 CAR T Cells Receives: Drug: TmPSMA-02 CAR T Cells |
| Dose Level 2 | Experimental | After lymphodepleting chemotherapy subjects to receive 1x10(8) TmPSMA-02 CAR T Cells Receives: Drug: TmPSMA-02 CAR T Cells |
| Dose Level 3 | Experimental | After lymphodepleting chemotherapy subjects to receive 3x10(8) TmPSMA-02 CAR T Cells Receives: Drug: TmPSMA-02 CAR T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with dose limiting toxicities (DLTs)
Measured: 28 days after TmPSMA-02 CAR T cell infusion
Determination of maximum tolerated dose (MTD)
Measured: 28 days after TmPSMA-02 CAR T cell infusion
Incidence of Adverse Events as assessed by CTCAE v5.0
Measured: Up to 15 years
Secondary outcomes (6)
Percentage of manufacturing products that meet release criteria
Measured: Up to 3 years
Overall Response Rate (ORR)
Measured: Up to 3 months
Duration of Response (DOR)
Measured: up to one year
Progression Free Survival (PFS)
Measured: Up to one year
Overall Survival (OS)
Measured: Up to one year
Percent Change in PSA from Baseline
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start31 Jan 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castrate-Resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Model description
- This is a Phase I, open-label dose finding study to assess the safety, tolerability, manufacturing feasibility, and preliminary efficacy of TmPSMA-02 CAR T cells in patients with metastatic castrate-resistant prostate cancer (mCRPC). Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046040
- Sponsor's protocol ID
- UPCC 11823
- Status last verified
- Aug 2026
- First submitted
- 13 Sep 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wang Y, Zhao G, Wang S, Li N. DNTGF-betaR armored CAR-T cell therapy against tumors from bench to bedside. J Transl Med. 2024 Jan 11;22(1):45. doi: 10.1186/s12967-023-04829-6. No abstract available.
PubMed 38212769
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-Label Study of Dually Armored Chimeric Antigen Receptor (CAR) T Cells (TmPSMA-02) in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT06046040
- Acronym / sponsor ID
- UPCC 11823
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Prostate Cancer Foundation
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2042 (estimated)
- First posted
- 21 Sep 2023 (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 I, open-label dose finding study to assess the safety, tolerability, manufacturing feasibility, and preliminary efficacy of TmPSMA-02 CAR T cells in patients with metastatic castrate-resistant prostate cancer (mCRPC). Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.
Detailed description
This is a Phase I, open-label dose finding study to assess the safety, tolerability, manufacturing feasibility, and preliminary efficacy of TmPSMA-02 CAR T cells in patients with metastatic castrate-resistant prostate cancer (mCRPC). Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design as described below. Dose escalation will begin with Dose Level 1 as follows:
- Dose Level 1 (N = 3 to 6): Subjects will receive a single dose of 5 x 107 TmPSMA-02 CAR T cells via IV infusion administration on Day 0, following lymphodepletion with fludarabine and cyclophosphamide. This dose level will be evaluated as follows:
- If 1 DLT/3 subjects occurs, the study will enroll an additional 3 subjects at this dose level.
- If 0 DLT/3 subjects or 1 DLT/6 subjects occur, the study will advance to Dose Level 2 (DL2).
- In the event that 2 or more DLTs occur at Dose Level 1 (DL1), enrollment at this dose level will be stopped and Dose Level -1 (DL-1) will be opened. In Dose Level -1, subjects will receive a de-escalated dose of 1 x 107 TmPSMA-02 CAR T cells following lymphodepletion.
If 0 DLT/3 or 1 DLT/3 subjects occurs at DL-1, the study will enroll an additional 3 subjects at this dose level.
If ≥ 2 DLTs occur at any time, enrollment at this dose level will be stopped.
Dose Level 2 (N = 3 to 6): Subjects will receive a single fixed dose of 1 x 108 TmPSMA-02 CAR T cells via IV infusion on Day 0, following lymphodepletion with fludarabine and cyclophosphamide. This dose level will be evaluated as follows:
- If 1 DLT/3 subjects occurs, the study will enroll an additional 3 subjects at this dose level.
- If 0 DLT/3 subjects or 1 DLT/6 subjects occur, the study will advance to Dose Level 3 (DL3).
- If 2 DLTs occur at any time, enrollment at this dose level will be stopped. If less than 6 subjects were treated at the previous dose level (DL1), additional subjects will be enrolled at that dose level to reach a minimum of 6 DLT-evaluable subjects for MTD determination.
- Dose Level 3 (N = 3 to 6): Subjects will receive a single fixed dose of 3 x 108 TmPSMA-02 CAR T cells via IV infusion Day 0, following lymphodepletion with fludarabine and cyclophosphamide. This dose level will be evaluated as follows:
- If 1 DLT/3 subjects occurs, the study will enroll an additional 3 subjects at this dose level.
- If 0 DLT/3 subjects occurs, the study will still enroll an additional 3 subjects at this dose level to allow for MTD determination.
- If 2 DLTs occur at any time, enrollment at this dose level will be stopped. If less than 6 subjects were treated at the previous dose level (DL2), additional subjects will be enrolled at that dose level to reach a minimum of 6 DLT-evaluable subjects for MTD determination.
The highest dose at which 0 or 1 DLT occurs in 6 DLT-evaluable subjects will be declared the MTD.
Retreatment Infusions:
The Retreatment Phase will remain closed until sufficient safety and persistence data is available in initial subjects, and DSMB and FDA approval to open Retreatment has been received.
Subjects who have demonstrated clinical benefit after their initial TmPSMA-02 CAR T cell infusion (e.g., minimum disease response of stable disease, etc.) may also be eligible to receive retreatment with TmPSMA-02 CAR T cells at the physician-investigator's discretion. The TmPSMA-02 retreatment dose administered must either be a) the CAR T cell dose that the subject previously received without DLTs, or b) a CAR T cell dose that is less than or equal to a dose level that has been evaluated for safety in ≥ 3 other subjects without evidence of DLTs. As retreatment infusions will not be used for formal DLT assessments/MTD determination, there are no protocol-defined staggering requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a Phase I, open-label dose finding study to assess the safety, tolerability, manufacturing feasibility, and preliminary efficacy of TmPSMA-02 CAR T cells in patients with metastatic castrate-resistant prostate cancer (mCRPC). Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design
| Arm | Type | Receives |
|---|---|---|
| Dose Level -1 | Experimental | Drug: TmPSMA-02 CAR T CellsAfter lymphodepleting chemotherapy subjects to receive 1x10(7) TmPSMA-02 CAR T Cells |
| Dose Level 1 | Experimental | Drug: TmPSMA-02 CAR T CellsAfter lymphodepleting chemotherapy subjects to receive 5 x10(7) TmPSMA-02 CAR T Cells |
| Dose Level 2 | Experimental | Drug: TmPSMA-02 CAR T CellsAfter lymphodepleting chemotherapy subjects to receive 1x10(8) TmPSMA-02 CAR T Cells |
| Dose Level 3 | Experimental | Drug: TmPSMA-02 CAR T CellsAfter lymphodepleting chemotherapy subjects to receive 3x10(8) TmPSMA-02 CAR T Cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed, written informed consent
- Adult participants ≥ 18 years of age
- Metastatic castrate-resistant prostate cancer (mCRPC)
- Castrate levels of testosterone (<50 ng/dL) with/without the use of androgen-deprivation therapy
- Received at least one prior standard therapy for systemic treatment in the mCRPC setting, including at least one second generation androgen receptor signaling inhibitor (e.g., enzalutamine, apalutamide, darolutamide, or abiraterone) or a taxane-based regimen (e.g., docetaxel, cabazitaxel, etc).
Key exclusion criteria (10 listed)
- Active hepatitis B or hepatitis C infection
- Any other active, uncontrolled infection
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- Severe, active co-morbidity that in the opinion of the physician-investigator would preclude participation in the study.
- Active invasive cancer, other than the proposed cancer included in the study, within 2 years prior to eligibility confirmation by a physician-investigator. [Note: non-invasive cancers treated with curative intent (e.g., non-melanoma skin cancer) may still be eligible].
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 |
|---|---|---|
| TmPSMA-02 CAR T CellsTmPSMA-02 CAR T cells: autologous T cells transduced with a lentiviral vector to express an anti-PSMA CAR containing a humanized J591-derived scFv and CD2 co-stimulatory domain, and dually armored with a TGFβRDN and PD1.CD28 switch receptor. | Drug | Dose Level -1, Dose Level 1, Dose Level 2, Dose Level 3 |
Primary outcome
Number of subjects with dose limiting toxicities (DLTs)
Time frame: 28 days after TmPSMA-02 CAR T cell infusion
Determination of maximum tolerated dose (MTD)
Time frame: 28 days after TmPSMA-02 CAR T cell infusion
Incidence of Adverse Events as assessed by CTCAE v5.0
Time frame: Up to 15 years
6 secondary outcomes
Percentage of manufacturing products that meet release criteria
Time frame: Up to 3 years
Overall Response Rate (ORR)
Time frame: Up to 3 months
Duration of Response (DOR)
Time frame: up to one year
Progression Free Survival (PFS)
Time frame: Up to one year
Overall Survival (OS)
Time frame: Up to one year
Percent Change in PSA from Baseline
Time frame: Up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Derived from this study: PubMed 38212769Wang Y, Zhao G, Wang S, Li N. DNTGF-betaR armored CAR-T cell therapy against tumors from bench to bedside. J Transl Med. 2024 Jan 11;22(1):45. doi: 10.1186/s12967-023-04829-6. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TmPSMA-02 CAR T Cells in people with Metastatic Castrate-Resistant Prostate Cancer (mCRPC), 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 18 inclusion and 10 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 10 Aug 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?
Number of subjects with dose limiting toxicities (DLTs) (time frame: 28 days after TmPSMA-02 CAR T cell infusion). 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 NCT06046040, which also lists 1 linked publication.
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 10 Aug 2026.