Health TrialsbyHealthPanel

GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours

ConditionsAlveolar Soft Part SarcomaRenal Cell CarcinomaTriple Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age15+
SponsorCanadian Cancer Trials Group

About this trial

Only enrolling in Canada.

The purpose of this study is to identify the highest dose of GCAR1, a chimeric antigen receptor (CAR-T) cell therapy, that can be tolerated without causing very severe side effects, and to see what effects GCAR1 has on selected cancers

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Archival tumour specimen must be positive for GPNMB with high expression by immunohistochemistry (central laboratory testing).

Histologically and/or cytologically confirmed diagnosis of one of the following tumours that is advanced/ metastatic/ recurrent or unresectable, for which no curative therapy exists.

alveolar soft part sarcoma

renal cell carcinoma (excluding clear cell)

Disqualifiers

Participants on active anticancer therapy for other advanced or metastatic malignancies.

Concurrent treatment with other anti-cancer therapy

Prior therapy with a gene therapy product or any adoptive T cell therapy or prior GPNMB targeting therapy.

Live attenuated vaccination administered within 30 days prior to or planned within 30 days after GCAR1 therapy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Fludarabine

    Drug

    Assigned at enrollment

  • Cyclophosphamide

    Drug

    Assigned at enrollment

  • GCAR1

    Biological/Vaccine

    Dose escalation

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: GCAR1 InfusionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

To determine the recommended phase II dose (RP2D), defined as the next lower dose below the maximum administered dose, of GPNMB directed CAR T cell therapy

(GCAR1) in participants with selected tumours (alveolar soft part sarcoma, renal cell carcinoma (excluding clear cell), triple negative breast cancer) expressing GPNMB

Time frame
3 years

Secondary outcomes

1

Number and severity of adverse eventsGCAR1 utilizing CTCAE v5.0

Time frame
3 years
2

Overall response rate utilizing RECIST 1.1

Time frame
3 years
3

Duration of response

Time frame
3 years

Other outcomes

Sponsors and contacts

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

Canadian Cancer Trials Group

Lead sponsor

University of Calgary

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

BioCanRx

Collaborator

Source ClinicalTrials.gov
Apply now