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

NCT06358053 | Not Yet Recruiting Phase 1

• 1 other identifier: CRTE7A2-2302C
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cervical Cancer; Anal Cancer; Head and Neck Cancers; Other Solid Tumors

Keywords

HPV; E7; immunotherapy; T cell; Adoptive cell therapy; T cell receptor; TCR

Outcome Measures

Primary Outcomes (3)

• DLT

  Dose-limiting toxicity

  28 days

• RP2D

  Recommended Phase 2 Dose

  2 years

• cevents (SAEs).

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

  2 years

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  2 years

• Disease Control Rate (DCR)

  2 years

• Duration of Response (DOR)

  2 years

• Progression-Free Survival (PFS)

  2 years

• Overall Survival(OS)

  2 years

Other Outcomes (1)

• Peripheral blood TCR-T cell copy number

  2 years

Study Arms (1)

CRTE7A2-01 TCR-T cell therapy

EXPERIMENTAL

This study is a single-arm Phase I study, encompassing both dose escalation and dose expansion phases. Patients will undergo lymphocytapheresis, then treatment with TCR-T cell (at escalating doses) + IL-2

Drug: CRTE7A2-01 TCR-T cell therapy

Interventions

CRTE7A2-01 TCR-T cell therapy DRUG

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

Also known as: CRTE7A2

CRTE7A2-01 TCR-T cell therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age \>18 years and 65 years. 2. Patients with advanced solid tumors (such as cervical cancer, head and neck tumors, anal cancer, and other malignancies) who have failed standard treatment confirmed by histology and/or cytology, or who are intolerant to such treatment, and for whom there is no effective therapy available after standard treatment failure are considered as end-stage patients. Specifically for:
• 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).
• \. Confirmation of HPV16 positive and HLA-A\*02:01 allele. 4. ECOG performance status of 0-1. 5. Estimated life expectancy ≥ 3 months. 6. Patients must have at least one measurable lesion defined by RECIST 1.1. 7. Female patients of childbearing age must undergo a serum pregnancy test within 7 days prior to study treatment and the results must be negative, and are willing to use a very effective and reliable method of contraception from screening through 6 months after the last dose of study treatment.
• \. The patient must be willing to sign the informed consent form and have a good anticipation of compliance with study procedure.

You may not qualify if:

• 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.
• Patients have any organ system function impairment as defined below:
• leukocytes\<3.0 x 109/L
• absolute neutrophil count \>1.5 x 109/L
• hemoglobin\<90g/L
• platelets \<100 x 1010/L
• lymphocytes\<0.5 x 109/L
• percentage of lymphocytes\<15%
• creatinine\>1.5×ULN or creatinine clearance \<50mL/min
• total bilirubin\>3×ULN; ALT/AST\>3×ULN (patients with liver metastasis,\>5×ULN)
• INR\>1.5×ULN; APTT\>1.5×ULN
• SpO2≤90%
• \. Patinets has serious medical conditions, disorders, and / or comorbidities, including, but are not limited to: severe heart disease, cerebrovascular disease, epileptic seizures, uncontrolled diabetes (CTCAE 5.0: FBG ≥ 2 grade), active infection, active digestive tract Ulcer, gastrointestinal bleeding, intestinal obstruction, pulmonary fibrosis, renal failure, respiratory failure.

Sponsors & Collaborators

• Corregene Biotechnology Co., Ltd: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Anus Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Study Officials

• Yang Xiang, Doctor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sa Wang, Master

CONTACT

010-86464526; wangsa@corregene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 10, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share