CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers

NCT05122221 | Unknown Phase 1

• 1 other identifier: CRTE7A2-2107C
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

A single center, open, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cell for HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine MTD of CRTE7A2-01 TCR-T cell injection, as well as investigate RP2D.

Conditions

Cervical Cancer; Anal Cancer; Head and Neck Cancers

Keywords

3+3 dose escalation

Outcome Measures

Primary Outcomes (4)

• MTD

  Maximum Tolerated Dose

  28 days

• DLT

  Dose-limiting toxicity

  28 days

• RP2D

  Recommended Phase II Dose

  28 days

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

  grade 1-5 (CTCAE)

  2 years

Secondary Outcomes (4)

• Objective Response Rate（ORR）

  2 years

• Disease Control Rate（DCR）

  2 years

• Duration of Response（DOR）

  2 years

• Progression-Free Survival（PFS）

  2 years

Other Outcomes (2)

• Peripheral blood TCR-T cell copy number

  2 years

• Negative conversion rate among HPV-16 positive patients detected by tissue biopsy

  2 years

Study Arms (1)

CRTE7A2-01 TCR-T cell therapy

EXPERIMENTAL

Patients will undergo lymphocytapheresis, then treatment with TCR-T cell (at escalating doses) + IL-2

Drug: Fludarabine + Cyclophosphamide; Drug: Interleukin-2; Biological: CRTE7A2-01 TCR-T Cell

Interventions

Fludarabine + Cyclophosphamide DRUG

Fludarabine: 25mg/m²/day×3days Cyclophosphamide: 500mg/m²/day×3 days

CRTE7A2-01 TCR-T cell therapy

Interleukin-2 DRUG

Interleukin-2 20,000,000 IU/time infused within 15 minutes approximately every 8 hours (according to the subject's tolerance, the interval between medications can be extended to 24 hours) for a maximum usage time up to 14 days.

CRTE7A2-01 TCR-T cell therapy

CRTE7A2-01 TCR-T Cell BIOLOGICAL

On day 0, the TCR-T cells will be administered one time, each bag of cell intravenously within 20 minutes.

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.
• Histologically-confirmed cervical cancer, anal cancer, head and neck cancers with confirmed HPV16 infection and HLA-A\*02:01 allele
• Failure on or intolerance to systemic therapy for unresectable advanced cancer.
• ECOG performance status of 0-1.
• Estimated life expectancy ≥ 3 months.
• Patients must have at least one measurable lesion defined by RECIST 1.1.
• 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:

• The proportion of T cell immune-related gene deletion mutations\>5%.
• Patient received any genetically modified T cell therapy.
• Patient who 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 with any organ dysfuntion 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\<0.8 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%

Sponsors & Collaborators

• Corregene Biotechnology Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Anus Neoplasms; Head and Neck Neoplasms

Interventions

fludarabine; Cyclophosphamide; Interleukin-2

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Central Study Contacts

Sa Wang, Master

CONTACT

8610-86464526-840; 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: November 5, 2021
• First Posted: November 16, 2021
• Study Start: July 17, 2022
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2024
• Last Updated: June 28, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)