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

NCT ID: NCT04562298

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-21
• Study Completion Date: 2022-06-07

Brief Summary

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.

Conditions

Epithelial Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LCAR-M23 Chimeric Antigen Receptor T cell

Group Type: EXPERIMENTAL

LCAR-M23 cells

Intervention Type: BIOLOGICAL

Prior to infusion of LCAR-M23, subjects will receive a premedication regimen (intravenous infusion of cyclophosphamide 300 mg/m2 and fludarabine 30 mg/m2 once daily for 3 days; fludarabine dose reduction to 25 mg/m2 and cyclophosphamide to 250 mg/m2 are allowed if the subject' s creatinine clearance is 50-70 mL/min/1.73 m2). A single dose, single Infusion of LCAR-M23 is scheduled 5 to 7 days after the initiation of the premedication regimen.

Interventions

LCAR-M23 cells

Prior to infusion of LCAR-M23, subjects will receive a premedication regimen (intravenous infusion of cyclophosphamide 300 mg/m2 and fludarabine 30 mg/m2 once daily for 3 days; fludarabine dose reduction to 25 mg/m2 and cyclophosphamide to 250 mg/m2 are allowed if the subject' s creatinine clearance is 50-70 mL/min/1.73 m2). A single dose, single Infusion of LCAR-M23 is scheduled 5 to 7 days after the initiation of the premedication regimen.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Legend Biotech Co.

INDUSTRY

Sponsor Role: collaborator

East Clinical Center of Oncology

UNKNOWN

Sponsor Role: collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Shanghai East Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ye Guo, PhD

Role: PRINCIPAL_INVESTIGATOR

East Clinical Center of Oncology

Yu Kang, PhD

Role: PRINCIPAL_INVESTIGATOR

Obstetrics & Gynecology Hospital of Fudan University

Locations

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

BM2L201906

Identifier Type: -

Identifier Source: org_study_id