CART-PSMA-TGFβRDN for Metastatic Castration-resistant Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Metastatic Castration-resistant Prostate CancerCART-PSMA-TGFβRDN - Biological
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment that uses genetically modified T cells to attack prostate cancer cells. The goal is to see if the treatment is safe and works well against the cancer.

Eligible Conditions
  • Metastatic Castration-resistant Prostate Cancer

Treatment Effectiveness

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Up to 15 years

Up to 15 years
Peripheral expansion and persistence of CART-PSMA-TGFβRDN
Up to 2 years
Cohort Expansion: Safety of CART-PSMA-TGFβRDN
Dose Escalation: Dose Identification of CART-PSMA-TGFβRDN
Feasibility of CART-PSMA-TGFβRDN
Preliminary efficacy of CART-PSMA-TGFβRDN as assessed by biochemical Objective Response Rate (ORR)

Trial Safety

Trial Design

1 Treatment Group

Dose Escalation
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: CART-PSMA-TGFβRDN · No Placebo Group · Phase 1

Dose EscalationExperimental Group · 4 Interventions: CART-PSMA-TGFβRDN, Cyclophosphamide, Fludarabine, Anakinra · Intervention Types: Biological, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fludarabine
FDA approved
Anakinra
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years

Who is running the clinical trial?

Tmunity TherapeuticsLead Sponsor
6 Previous Clinical Trials
304 Total Patients Enrolled
1 Trials studying Metastatic Castration-resistant Prostate Cancer
114 Patients Enrolled for Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The individual has confirmed prostate cancer and has metastatic castrate resistant prostate cancer, with levels of testosterone below 50 ng/mL.
The Prostate Working Group 3 has developed a set of criteria for diagnosing prostate cancer
The person has an estimated glomerular filtration rate of ≥ 60 mL/min, as estimated by the Modification of Diet in Renal Disease criteria.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be ≤ 2.5x the upper limit of normal (ULN) if the patient has hepatic metastases
The patient's serum total bilirubin level should be less than 1.5 mg/dL, except if the patient has known Gilbert's Syndrome, in which case the serum bilirubin level should be less than 3 mg/dL.
The absolute neutrophil count must be at least 1000/μL.
You have a hemoglobin level of at least 8 g/dL.
You have received at least two prior lines of systemic therapy for prostate cancer, including at least one second generation and/or CYP17α inhibitor and/or AR inhibitor.