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

NCT06728189 | Recruiting Phase 1

• 1 other identifier: CGC738-IIT-01
• Study Type: interventional
• Target: 13
• 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 CGC738 in the treatment of advanced malignant solid tumors. Condition or disease：advanced malignant solid tumors Intervention/treatment：Biological: CD70 CAR-NKT cells Phase：Phase 1

Conditions

Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)

  Dose limiting toxicity (DLT) is an AE that meets the following criteria and occurs within 28 days of CGC729 infusion.AE is graded according to CTCAE version 5.0.

  Day 28 after CGC738 infusion

Secondary Outcomes (4)

• Assess Objective response rate (ORR)

  Day 1 through week 56

• Assess Disease control rate (DCR)

  Day 1 through week 56

• Incidence of adverse events (AEs)

  Day 1 through week 56

• Cmax, Tmax, AUCS of CD70 CAR-NKT cell dynamics

  Day 1 through week 56

Study Arms (1)

CAR-NKT Cells Lymphodepleting regimen

EXPERIMENTAL

Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells 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.

Biological: CAR-NKT Cells treatment

Interventions

CAR-NKT Cells treatment BIOLOGICAL

Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells 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 CGC738 doses: Dose level 1: 5.0×106 CAR- NKT cells/m2; Dose level 2: 1.5×107 CAR- NKT cells/m2; Dose level 3: 4.5×107 CAR- NKT cells/m2;

CAR-NKT Cells Lymphodepleting regimen

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:
• 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.
• 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.
• 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

• Peking University Cancer Hospital & Institute: lead
• Suzhou Cure Genetics Biosciences Co., Limited.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

Central Study Contacts

Xinan Sheng Professor, MD

CONTACT

+86-10-88196348; doctor_sheng@126.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: Deputy Director of Peking University Cancer Hospital & Institute；Director of Renal Cancer and Melanoma Department.

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 11, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): October 17, 2026
• Study Completion (Estimated): October 17, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)