Advanced Clear Cell Renal Cell Carcinoma
Conditions
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 clear cell renal cell carcinoma (ccRCC).
Detailed description
This is a single-arm, open-label study. This study will include two parts, dose escalation phase (3+3 design) followed by a dose expansion phase. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by CAR-T cell injection. Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of anti-CD70 CAR-T cell injection.
Interventions
DRUGCGC738
CAR-NKT Cells treatment
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Age 18 to 75 years. * 2.ECOG 0-1 points. * 3\. The expected survival time is more than 3 months. * 4\. Patients with advanced ccRCC confirmed by histology or cytology to be recurrent or metastatic after at least first-line treatment. * 5\. IHC: CD70 positive. * 6\. At least one measurable lesion at baseline per RECIST version 1.1. * 7\. The functions of important organs are basically normal: * 8\. Pregnancy tests for women of childbearing age shall be negative, both men and women agreed to use effective contraception.
Exclusion criteria
* 1\. Use of cell therapy within the previous one month. * 2\. 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. * 3\. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms. * 4\. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion. * 5\. Active hepatitis B, HIV positive and HCV positive. * 6\. Active infection or uncontrollable infection. * 7\. Uncontrollable or significant heart disease. * 8\. Unstable respiratory diseases, including interstitial pneumonia. * 9\. Uncontrolled ascites and pleural effusion. * 10.Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. * 11.Subjects who are using systemic steroids or steroid inhalers for treatment. * 12.Pregnant or lactating female subjects. * 13.Other investigators deem it unsuitable to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) | Day 28 after CGC738 infusion | Dose limiting toxicity (DLT) is an AE that meets the following criteria and occurs within 28 days of CGC738 infusion.AE is graded according to CTCAE version 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | Day 1 through week 56 | Assess Objective response rate |
| DCR | Day 1 through week 56 | Assess Disease control rate |
| AEs | Day 1 through week 56 | Incidence of adverse events |
Contacts
Primary ContactZhai Wei
Outcome results
None listed