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Patients to be followed up in the CRSP-ONC-LTF study
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This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.
The study may enroll approximately 45 subjects in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTX130 | Experimental | Administered by IV infusion following lymphodepleting chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTX130 | Biological | CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A (dose escalation) | Incidence of adverse events | From CTX130 infusion up to 28 days post-infusion |
| Part B (cohort expansion) | Objective response rate | From CTX130 infusion up to 60 months post-infusion] |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months | |
| Overall Survival | From date of CTX130 until date of death due to any cause, assessed up to 60 months |
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Inclusion Criteria (abbreviated):
Exclusion Criteria (abbreviated):
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| Name | Affiliation | Role |
|---|---|---|
| Alissa Keegan, PhD | CRISPR Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site 2 | Duarte | California | 91010 | United States | ||
| Research Site 5 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39617017 | Derived | Iyer SP, Sica RA, Ho PJ, Prica A, Zain J, Foss FM, Hu B, Beitinjaneh A, Weng WK, Kim YH, Khodadoust MS, Huen AO, Williams LM, Ma A, Huang E, Ganpule A, Nagar SD, Sripakdeevong P, Cullingford EL, Karnik S, Dequeant ML, Patel JN, He XS, Li Z, He QA, Mendonez JH, Keegan A, Horwitz SM. Safety and activity of CTX130, a CD70-targeted allogeneic CRISPR-Cas9-engineered CAR T-cell therapy, in patients with relapsed or refractory T-cell malignancies (COBALT-LYM): a single-arm, open-label, phase 1, dose-escalation study. Lancet Oncol. 2025 Jan;26(1):110-122. doi: 10.1016/S1470-2045(24)00508-4. Epub 2024 Nov 29. | |
| 37093350 |
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| Stanford |
| California |
| 94305 |
| United States |
| Research Site 10 | New Haven | Connecticut | 06520 | United States |
| Research Site 4 | Miami | Florida | 33124 | United States |
| Research Site 9 | New York | New York | 10065 | United States |
| Research Site 8 | The Bronx | New York | 10467 | United States |
| Research Site 1 | Houston | Texas | 77030 | United States |
| Research Site 6 | Salt Lake City | Utah | 84112 | United States |
| Research Site 3 | Sydney | New South Wales | 2050 | Australia |
| Research Site 7 | Toronto | Ontario | M5G 2C1 | Canada |
| Derived |
| Dewulf J, Flieswasser T, Delahaye T, Vangestel C, Miranda A, de Haard H, Jacobs J, Smits E, Van den Wyngaert T, Elvas F. Site-specific 68Ga-labeled nanobody for PET imaging of CD70 expression in preclinical tumor models. EJNMMI Radiopharm Chem. 2023 Apr 24;8(1):8. doi: 10.1186/s41181-023-00194-3. |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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