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A Phase I Trial of CCT303-406 in Patients With Relapsed or Refractory HER2 Positive Solid Tumors | Clinical Trials | Clareo Health

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A Phase I Trial of CCT303-406 in Patients With Relapsed or Refractory HER2 Positive Solid Tumors

A Phase I Trial to Assess Safety, Tolerability and Anti-tumor Activity of Autologous T Cell Modified Chimeric Antigen Receptor (CAR) (CCT303-406) in Patients With Relapsed or Refractory HER2 Positive Solid Tumors

NCT04511871•Shanghai PerHum Therapeutics Co., Ltd.

View on ClinicalTrials.gov

Summary

This clinical study is to investigate the safety and tolerability of CCT303-406 CAR modified autologous T cells (CCT303-406) in subjects with relapsed or refractory stage IV metastatic HER2-positive solid tumors.

Detailed Description

This is a single arm, open label, dose escalation clinical study to evaluate the safety and preliminary therapeutic efficacy of CCT303-406 cells in adult subjects with HER2 positive relapsed or refractory stage IV metastatic solid tumors. Subjects that meet inclusion criteria with positive biopsy HER2 (IHC 3+ in ≥50% tumor cells) will receive CCT303-406 according to the 3+3 dose escalation design.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with willingness to be in the study and follow all study procedures, and capable of providing informed consent
•2. Male or female aged 18-70 years
•3. Patients with stage IV (according to the 8th edition of AJCC) advanced solid tumor malignancies that have failed standard treatment of relapsed or difficult-to-treat solid tumors confirmed by histology or cytology
•4. At least one measurable lesion, i.e. the length of non-lymph node lesions examined according to CT cross-sectional scanning or magnetic resonance imaging (MRI), or the short diameter of the lymph node lesions is ≥15 mm according to RECIST 1.1
•5. Tumors with HER2 IHC 3+ in≥50% of all tumor cells as determined by IHC according to the Breast Cancer HER2 Testing (2019 edition) and the Gastric Cancer HER2 Testing (2016 edition); For HER2 IHC 3+ tumors other than gastric and breast cancers, FISH is required to confirm HER2 expression; For relapsed patients after HER2-targeted therapies, biopsy and IHC are required to confirm HER2 expression per enrollment criteria.
•6. ECOG Performance Status 0-1
•7. Expected survival greater than 12 weeks
•8. Adequate organ and hematopoietic system functions to meet the following requirements:
•* Hemoglobin (HGB) s 90 g/L, no blood transfusions within two weeks;
•* White blood cell (WBC) count≥2.5×109/L
+12 more criteria

Exclusion Criteria

•1. Females with pregnancy or in lactation period
•2. Patients with active hepatitis B, or active hepatitis C
•3. HIV positive
•4. Other active infections of clinical significance
•5. Patients receiving in situ surgery within 3 months
•6. Patients with the following previous or accompanying diseases:
•• Patients diagnosed as severe autoimmune diseases that require long term (more than 2 months) treatment with systemic immunosuppressants (steroids), or diseases with immune-mediated symptoms, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), and autoimmune vasculitis
•7. Patients with ≥Grade 2 peripheral neuronal diseases (according to NCI-CTCAE v5.0)
•8. Patients with any mental illness, including dementia, mental changes, which may cause difficulties understanding the informed consent and related questionnaires
•9. Patients with serious uncontrollable diseases, which may interfere with the therapies in this study
+13 more criteria

Locations (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

July 9, 2020

Primary Completion Date

October 24, 2024

Completion Date

March 29, 2025

Last Updated

October 28, 2024

Enrollment

ACTUAL participants

Conditions

Solid TumorGastric CancerBreast CancerOvarian CancerSarcoma

Interventions

CCT303-406

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase I Trial of CCT303-406 in Patients With Relapsed or Refractory HER2 Positive Solid Tumors

Inclusion Criteria

Exclusion Criteria

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