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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
This was a dose-expansion study, we plan to enroll 6 to 12 patients with CD70-positive advanced malignant solid tumors to CGC729 treatment. The intended enrollment for the evaluation of treatment efficacy and safety was planned to be 3 to 6 patients per tumor type.
We used leukapheresis for cell collection. The lymphodepletion procedure was conducted using a combination of fludarabine and cyclophosphamide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells | Combination Product | Biological: CD70 CAR-NKT cells. Drug: Cyclophosphamide. Drug: Fludarabine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR of CD70 CAR-NKT cell dynamics | Assess Objective response rate | Day 1 through week 56 |
| Measure | Description | Time Frame |
|---|---|---|
| DCR of CD70 CAR-NKT cell dynamics | Disease control rate | Day 1 through week 56 |
| DOR of CD70 CAR-NKT cell dynamics | Duration of Response |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhang | Contact | 18017312991 | syner2000@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Zhang | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Day 1 through week 56 |
| PFS of CD70 CAR-NKT cell dynamics | Progress Free Survival | Day 1 through week 56 |
| OS of CD70 CAR-NKT cell dynamics | Overall survival | Day 1 through week 56 |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |