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Phase I Study of In Vivo CAR-Tumor Technology for the Treatment of Advanced Malignant Tumors

ConditionAdvanced Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

This study is a single-arm, open-label, dose-escalation platform clinical trial designed to evaluate the safety, tolerability, efficacy, pharmacokinetic and pharmacodynamic characteristics of CAR-Tumour oncolytic virus as a vector platform for the treatment of advanced malignant tumours.

Subjects will be screened and assigned to cohorts based on target and indication:

Cohort A: Intratumoural injection or intravenous injection of CAR-Tumor05 solution for the treatment of advanced malignant solid tumours Co-group B: Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, and intraperitoneal perfusion of CAR-Tumor05 injection for the treatment of advanced malignant solid tumours Co-group C: Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, and intraperitoneal perfusion of CAR-Tumor M01 injection for the treatment of advanced malignant solid tumours

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign the informed consent form, understand the study, agree to comply with the protocol, and agree to complete all trial procedures;

Be aged 18 years or over at the time of signing the informed consent form; gender is not restricted.

Patients with advanced solid tumours confirmed by histological and/or cytological examination of the primary and/or metastatic lesions.

Patients who have failed standard treatment, are at the end of standard treatment options, or are unsuitable for standard treatment for medical reasons.

Disqualifiers

Subjects who have had other active malignant tumours within the past 5 years. Excluded are subjects who have been completely cured and do not require follow-up treatment, and subjects whose malignant tumours fall within the scope of the indication;

The longest diameter of the lesion to be injected is >100 mm;

Subjects who have participated in or are currently participating in clinical trials of other drugs or medical devices within the past 4 weeks;

Subjects who are scheduled to undergo or have previously undergone a tissue/organ transplant;

Trial design

Design model

Parallel

Treatments tested in this trial

  • CAR-Tumor05

    Biological/Vaccine

    Intralesional injection, intravenous injection

  • CAR-Tumor 05

    Biological/Vaccine

    Intralesional injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, intraperitoneal perfusion

  • CAR-Tumor M01

    Biological/Vaccine

    Intralesional injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, intraperitoneal perfusion

Treatment groups

27 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DLT

In accordance with the internationally recognised CTCAE V6.0 toxicity assessment criteria

Time frame
the study drug OVV-01 occurring within 3 weeks of the first dose.

Secondary outcomes

1

Incidence of Adverse Events (AEs)

Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0.

Time frame
From signing ICF until 24 months after the last infusion
2

ORR

The proportion of subjects achieving CR or PR will be assessed according to RECIST 1.1.

Time frame
Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
3

DCR

The proportion of subjects achieving CR, PR, or SD will be assessed according to RECIST 1.1.

Time frame
Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months
4

PFS

The time from the first study treatment to the first documented disease progression or death from any cause (whichever occurs first) will be assessed according to RECIST 1.1.

Time frame
Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.

Other outcomes

Sponsors and contacts

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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Joint Biosciences Ltd.

Collaborator

Source ClinicalTrials.gov

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