A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors

NCT06394622 | Recruiting Phase 1

• 1 other identifier: CGC729-IIT-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC729 in the treatment of advanced malignant solid tumors. Condition or disease:advanced malignant solid tumors. Intervention/treatment:Biological: CD70 CAR-NKT cells. Phase:I

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• ORR of CD70 CAR-NKT cell dynamics

  Assess Objective response rate

  Day 1 through week 56

Secondary Outcomes (4)

• DCR of CD70 CAR-NKT cell dynamics

  Day 1 through week 56

• DOR of CD70 CAR-NKT cell dynamics

  Day 1 through week 56

• PFS of CD70 CAR-NKT cell dynamics

  Day 1 through week 56

• OS of CD70 CAR-NKT cell dynamics

  Day 1 through week 56

Study Arms (1)

Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells

EXPERIMENTAL

Lymphodepleting regimen, Cyclophosphamide 250mg/m2 IV on day -5 to -3 and Fludarabine 25mg/m2 IV on days -5 to -3. Followed by infusion of CAR-NKT on day 0. Potential CGC729 doses: Dose level 1: 5.0×106 CAR- NKT cells/m2; Dose level 2: 1.5×107 CAR- NKT cells/m2;

Combination Product: Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells

Interventions

Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells COMBINATION_PRODUCT

Biological: CD70 CAR-NKT cells. Drug: Cyclophosphamide. Drug: Fludarabine.

Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years.
• ECOG 0-1 points.
• The expected survival time is more than 3 months.
• Patients with advanced advanced malignant solid tumor confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment.
• IHC: CD70 positive.
• At least one measurable lesion at baseline per RECIST version 1.1.
• The functions of important organs are basically normal:Hematopoietic function:
• neutrophils 1.5×109/L, platelets 75×109/L, hemoglobin 80g/L;Renal function: creatinine clearance of ≥60 mL/min.;Liver function: ALT and AST ≤2.5×ULN (≤5 × ULN for patients with liver metastases);Total bilirubin ≤1.5×ULN.Prothrombin time (PT) : INR \< 1.7.
• Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception.
• Subjects or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.

You may not qualify if:

• Use of cell therapy within the previous one month.
• Risk of severe bleeding in esophageal cancer
• Subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment.
• Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms in the past 6 months.
• Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
• Active hepatitis B, HIV positive and HCV positive
• Active infection or uncontrollable infection.
• Subjects with NYHA heart failure class ≥2 or hypertension uncontrolled by standard therapy requiring special treatment, previous history of myocarditis, or myocardial infarction within 6 months.
• Unstable respiratory diseases, including interstitial pneumonia.
• Uncontrolled ascites and pleural effusion
• Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. .
• Subjects who are using systemic steroids or steroid inhalers for treatment.
• Pregnant or lactating female subjects.
• Other investigators deem it unsuitable to participate in the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

Cyclophosphamide; fludarabine

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Jian Zhang

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhang

CONTACT

18017312991; syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Phase I Clinical Trial Center

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 1, 2024
• Study Start: April 11, 2024
• Primary Completion (Estimated): June 28, 2026
• Study Completion (Estimated): June 28, 2026
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)