A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-M23, a CAR-T Cell Therapy Targeting MSLN in Patients With Relapsed and Refractory Epithelial Ovarian Cancer

Tongji University

Status and phase: Terminated; Phase 1

Conditions: Epithelial Ovarian Cancer

Treatments: Biological: LCAR-M23 cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04562298

BM2L201906

Details and patient eligibility

About

This study is a prospective, single-arm, open-label, single-dose dose finding and extension study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the LCAR-M23 CAR-T cell therapy in subjects with relapsed and refractory epithelial ovarian cancer after prior adequate standard of care.

Enrollment: 15 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subjects have been fully informed of the possible risks and benefits of participating in this study and have voluntarily signed the informed consent form (ICF)
2. Age: 18-70 years (including 18 and 70 years)
3. Female subjects with histologically or cytologically confirmed advanced epithelial ovarian cancer including fallopian tube and primary peritoneal cancers
4. Mesothelin (MSLN) positive
5. Prior adequate standard of care, treatment failure or intolerance.
6. Imaging shows an evaluable tumor lesion
7. ECOG 0-1
8. Expected survival ≥ 3 months

Exclusion criteria

1. Patients who have received the following anti-tumor treatments prior to apheresis:

   • Cytotoxic therapy within 14 days
   • Small molecule targeted therapy within 14 days or at least 5 half-lives, whichever is shorter
   • Therapy with monoclonal antibody within 21 days
   • Immunomodulatory therapy within 7 days
   • Radiotherapy within 14 days and endocrine therapy within 14 days (including tamoxifen, aromatase inhibitor, high-potency progesterone and gonadotropin-releasing hormone analogue, etc.)

2. Previously treated with CAR-T/TCR-T cell therapy against any target or other cell therapies or therapeutic tumor vaccine

3. Previously treated with any MSLN-targeted therapy

4. Brain metastases with central nervous system symptoms

5. Pregnant or lactating women

6. Any condition in which, in the opinion of the investigator, the subject is ineligible for participation in the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

LCAR-M23 Chimeric Antigen Receptor T cell

Experimental group

Treatment:

Biological: LCAR-M23 cells