Clinical trial · Interventional
A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors
NCT06394622CI-TRIAL-00076637unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells
- description
- 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;
- interventionNames
- Combination Product: Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells
Primary outcomes (1)
- measure
- ORR of CD70 CAR-NKT cell dynamics
- timeFrame
- Day 1 through week 56
- description
- Assess Objective response rate
Secondary outcomes (4)
- measure
- DCR of CD70 CAR-NKT cell dynamics
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.