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This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131â„¢ in subjects with relapsed or refractory solid tumors.
An open-label, multi-center Phase 1/2 study of CTX131 in subjects with relapsed/refractory solid tumors. CTX131 is an is allogeneic CD70- directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTX131 | Experimental | Administered by IV infusion following lymphodepleting chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTX131 | Biological | CTX131 (CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 (Dose Escalation): Incidence of adverse events | Defined as dose-limiting toxicities | From CTX131 infusion up to 28 days post-infusion |
| Phase 2 (Cohort Expansion): Objective response rate (ORR) | ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to appropriate response evaluation criteria for each disease histology | From CTX131 infusion up to 60 months post-infusion |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site 3 | Duarte | California | 91010 | United States | ||
| Research Site 7 |
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| Chicago |
| Illinois |
| 60637 |
| United States |
| Research Site 6 | Boston | Massachusetts | 02215 | United States |
| Research Site 2 | St Louis | Missouri | 63110 | United States |
| Research Site 4 | Durham | North Carolina | 27710 | United States |
| Research Site 1 | Nashville | Tennessee | 37203 | United States |
| Research Site 5 | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D002583 | Uterine Cervical Neoplasms |
| D004938 | Esophageal Neoplasms |
| D000086002 | Mesothelioma, Malignant |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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