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Minor formatting updates. |
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identificationModule.briefTitle: Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma Patients |
identificationModule.briefTitle: Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia Patients |
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identificationModule.officialTitle: An Open-label, Multi-center, Single-arm Phase 1/2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Adult Patients With Relapsed or Refractory Large B-cell Lymphoma |
identificationModule.officialTitle: An Open-label, Multi-center, Single-arm Phase 1/2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Adult Patients With Relapsed or Refractory Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia |
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statusModule.statusVerifiedDate: 2021-04 |
statusModule.statusVerifiedDate: 2026-06 |
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statusModule.primaryCompletionDateStruct.date: 2023-05 |
statusModule.primaryCompletionDateStruct.date: 2030-08-15 |
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statusModule.completionDateStruct.date: 2028-02 |
statusModule.completionDateStruct.date: 2030-09-26 |
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statusModule.lastUpdateSubmitDate: 2021-04-29 |
statusModule.lastUpdateSubmitDate: 2026-06-29 |
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statusModule.lastUpdatePostDateStruct.date: 2021-05-03 |
statusModule.lastUpdatePostDateStruct.date: 2026-07-01 |
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descriptionModule.briefSummary: This is a multi-center, phase I/II study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma. |
descriptionModule.briefSummary: This is a multi-center, phase I/II study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma and B-cell Acute Lymphoblastic Leukemia. |
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Field `armsInterventionsModule.interventions.[0]description` changed from `A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.` to `Cohort A :A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg. |
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Cohort B :A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 1.5 x 10\^6 anti-CD19 CAR T cells/kg.` |
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outcomesModule.primaryOutcomes.[1]measure: Phase 2 Pivotal Study: Overall Response Rate (ORR) |
outcomesModule.primaryOutcomes.[1]measure: Phase 2 Pivotal Study: Cohort A : Overall Response Rate (ORR) Cohort B : Overall Complete Remission Rate (OCR) |
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Field `outcomesModule.primaryOutcomes.[1]description` changed from `ORR is defined as the incidence of either a complete response (CR) or a partial response (PR) per the Lugano Criteria for Response Assessment (2014).` to `Cohort A : ORR is defined as the incidence of either a complete response (CR) or a partial response (PR) per the Lugano Criteria for Response Assessment (2014). |
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Cohort B : OCR is defined as the incidence of either a complete Remission (CR) or a Complete Remission with incomplete hematologic recovery (CRi) per the ALL Response Criteria.` |
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Field `eligibilityModule.eligibilityCriteria` changed from `Inclusion Criteria: |
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1. ≥ 19 years of age and provided written informed consent |
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2. Histologically confirmed following large B-cell lymphomas according to the World Health Organization classification 2017 |
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* Diffuse large B-cell lymphoma, not otherwise specified Including Large cell transformation from follicular lymphoma (Transformed follicular lymphoma) |
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* High-grade B-cell lymphoma, not otherwise specified |
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* High-grade B-cell lymphoma with double-hit/triple-hit |
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* Primary mediastinal large B cell lymphoma |
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3. Relapsed or refractory disease after ≥ two lines of chemotherapy including rituximab, anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT) or being ineligible for or not consenting to ASCT. |
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4. At least one measurable lesion (Long diameter ≥ 1.5cm) |
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5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 |
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6. Adequate renal and hepatic functions based on the laboratory test results |
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* Total Bilirubin ≤ 2.0mg/dL w` to `Cohort A: |
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Inclusion Criteria: |
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1. ≥ 19 years of age and provided written informed consent |
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2. Histologically confirmed following large B-cell lymphomas according to the World Health Organization classification 2017 |
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* Diffuse large B-cell lymphoma, not otherwise specified Including Large cell transformation from follicular lymphoma (Transformed follicular lymphoma) |
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* High-grade B-cell lymphoma, not otherwise specified |
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* High-grade B-cell lymphoma with double-hit/triple-hit |
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* Primary mediastinal large B cell lymphoma |
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3. Relapsed or refractory disease after ≥ two lines of chemotherapy including rituximab, anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT) or being ineligible for or not consenting to ASCT. |
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4. At least one measurable lesion (Long diameter ≥ 1.5cm) |
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5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 |
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6. Adequate renal and hepatic functions based on the laboratory test results |
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* Total Bilirubin ≤` |