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Intervention of Bladder Cancer by CAR-T

ConditionsBladder CancerUrothelial Carcinoma Bladder
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShenzhen Geno-Immune Medical Institute

About this trial

This is a Phase I/II and multicenter study designed to evaluate the efficacy and safety of 4SCAR-T cells in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have no further treatment available.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra)

Representative tumor specimens as specified by the protocol

Adequate hematologic and end organ function

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Disqualifiers

Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment

Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment

Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments

Leptomeningeal disease

Trial design

Design model

Single group

Treatments tested in this trial

  • 4SCAR-PSMA

    Genetic

    PSMA-specific 4th Generation CART

  • 4SCAR-FRa

    Genetic

    FRa-specific 4th Generation CART

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: 4SCAR-PSMAExperimental treatment 1 intervention
Group B: 4SCAR-FRaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival rate after receiving 4SCART infusion

to determine the efficacy of 4SCAR T cells

Time frame
1 year
2

Using CTCAE 4 standard to evaluate the level of adverse events after receiving 4SCART infusion

to evaluate the level of adverse events with CTCAE 4

Time frame
3 months

Secondary outcomes

1

The expansion and persistence of 4SCAR T cells

The investigators will monitor the expansion and functional persistence of 4SCAR T cells in the peripheral blood of patients and the correlation with antitumor effects

Time frame
1 year
2

Immune responses after infusions

assessment of cytokine profile

Time frame
3 months

Other outcomes

Sponsors and contacts

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

Shenzhen Geno-Immune Medical Institute

Lead sponsor

Source ClinicalTrials.gov
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