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IL-18 Armored STEAP1 CAR T Cells for the Treatment of Metastatic Castration Resistant Prostate Cancer

ConditionsMetastatic Castration-Resistant Prostate AdenocarcinomaStage IVB Prostate Cancer AJCC v8
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorFred Hutchinson Cancer Center

About this trial

This phase I trial tests the safety, side effects, best dose and how well giving IL-18 armored STEAP1 CAR T cells after lymphodepleting chemotherapy (with cyclophosphamide and fludarabine) works for the treatment of castration resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Giving chemotherapy, with cyclophosphamide and fludarabine, prior to CAR T cells helps kill cancer cells in the body and prepare the body to receive the CAR T cells. Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving IL-18 armored STEAP1 CAR T cells after lymphodepleting chemotherapy may be safe, tolerable and/or effective in treating patients with metastatic castration resistant prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented, histologically confirmed adenocarcinoma of the prostate

Measurable disease by RECIST 1.1 criteria or bone only metastases with measurable PSA (≥ 1ng/mL)

Must have mCRPC with progressive disease (PD), stable disease (SD), lack of clinical benefit or intolerance to ≥ 1 line of systemic therapy, after becoming castration resistant

At least two lines of Food and Drug Administration (FDA)-approved therapies with at least one being a second-generation androgen receptor signaling inhibitor.

Disqualifiers

Expecting to conceive or father children for the duration of the trial through 4 months after T cell infusion

Patients that require immediate therapy due to mass effect or spinal cord compression

Active autoimmune disease: Participants with active autoimmune disease requiring chronic immunosuppressive therapy are excluded. Case by case exemptions are possible with approval by principal investigator (PI)

Corticosteroid therapy at a dose equivalent of > 10 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for disease control is acceptable

Trial design

Design model

Single group

Treatments tested in this trial

  • FH-STEAP1 IL-18 CAR T cells

    Biological/Vaccine

    Given FH-STEAP1 IL-18 CAR T cells IV

  • Antiandrogen Therapy

    Drug

    Receive standard of care androgen deprivation therapy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Scan

    Procedure/Surgery

    Undergo nuclear medicine bone scan

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Cyclophosphamide

    Drug

    Given IV

  • Echocardiography Test

    Procedure/Surgery

    Undergo echocardiography

  • Fludarabine

    Drug

    Given IV

  • Leukapheresis

    Procedure/Surgery

    Undergo leukapheresis

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA scan

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET scan

  • Biopsy Procedure

    Procedure/Surgery

    Undergo tumor biopsy

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Treatment (chemotherapy, FH-STEAP1 IL-18 CAR T cells)Experimental treatment 13 interventions

Trial outcomes

Primary outcomes

1

Treatment-related unexpected grade 3 or higher toxicity

Time frame
Up to 28 days post infusion
2

Incidence of adverse events

Time frame
Up to 28 days post infusion
3

Prostate cancer response

Assessed by Prostate Cancer Working Group 3 (PCWG3) criteria.

Time frame
Up to 1 year post infusion

Secondary outcomes

1

Progression free survival

Will be analyzed using Kaplan-Meier method and the results will be summarized by the median with a 95% confidence interval if appropriate.

Time frame
From initiation of protocol treatment to disease progression or death of any cause, up to 1 year post infusion
2

Overall survival

Will be analyzed using Kaplan-Meier method and the results will be summarized by the median with a 95% confidence interval if appropriate.

Time frame
From initiation of protocol treatment to death of any cause, up to 1 year post infusion
3

Objective response rate

Defined as complete response or partial response by Response Evaluation Criteria in Solid Tumors 1.1 criteria and PCWG 3.

Time frame
Up to 1 year post infusion
4

Stable disease

Assessed by RECIST 1.1 criteria and PCWG3.

Time frame
Up to 1 year post infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

PromiCell Therapeutics, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: