CRTE7A2-01 TCR-T Cells for HPV-16 Positive Advanced Cancers

ConditionsCervical Cancer Anal Cancer Head and Neck Cancers Other Solid Tumors

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorCorregene Biotechnology Co., Ltd

About this trial

A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A\*02:01+ Subjects HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine RP2D of CRTE7A2-01 TCR-T cell injection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cervical cancer: a) Patients who have previously failed at least second-line systemic therapy (including at least one platinum-based regimen or anti-angiogenic therapy) and have shown disease progression or intolerance confirmed by pathological or radiological examination during or after the most recent treatment course, and are not amenable to treatment with surgery or radiotherapy, with no standard treatment options currently available for recurrent or metastatic cervical cancer.

Nasopharyngeal cancer: a) Patients who have previously failed at least third-line systemic therapy or are intolerant, not amenable to treatment with surgery or radiotherapy, with no standard treatment options currently available for recurrent or metastatic nasopharyngeal cancer; b) EB virus negative.

Head and neck squamous cell carcinoma: a) Patients who have previously failed at least second-line systemic therapy or are intolerant, with no standard treatment options currently available for recurrent or metastatic head and neck squamous cell carcinoma (non-nasal).

Disqualifiers

Patient received any genetically modified T cell therapy.

Patient is being treated with T cell immunosuppressive agent （such as cyclophosphamide, FK506,tripterygium glycosides） or T cell immunoagonist.

Patients received chemotherapy, targeted therapy, immunotherapy, or other investigational agents within 2 weeks and received radiotherapy within 4 weeks before apheresis.

leukocytes<3.0 x 109/L

Trial design

Design model

Single group

Treatments tested in this trial

CRTE7A2-01 TCR-T cell therapy
Drug
Drug 1: Fludarabine + Cyclophosphamide Drug 2: Interleukin-2 Drug 3: CRTE7A2-01 TCR-T Cell

Treatment groups

24 Participants

are divided into 1 treatment group

Group A: CRTE7A2-01 TCR-T cell therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

DLT

Dose-limiting toxicity

Time frame

28 days

RP2D

Recommended Phase 2 Dose

Time frame

2 years

cevents (SAEs).

Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs).

Time frame

2 years

Secondary outcomes

Objective Response Rate (ORR)

Assessed by RECIST 1.1

Time frame

2 years

Disease Control Rate (DCR)

Assessed by RECIST 1.1

Time frame

2 years

Duration of Response (DOR)

Assessed by RECIST 1.1

Time frame

2 years

Progression-Free Survival (PFS)

Assessed by RECIST 1.1

Time frame

2 years

Other outcomes

Peripheral blood TCR-T cell copy number

Time frame

2 years

Locations

This trial has no locations.

Sponsors and contacts

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

Corregene Biotechnology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

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