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This study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells
Patients will be enrolled following either the completion or early termination/discontinuation from Study NCT04450069 or any protocol in which patients were administered CLBR001. Patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. Patients will be followed for up to 15 years post CLBR001 infusion and will continue to be monitored for safety, immunogenicity, and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLBR001 treated patients | Experimental | Patients who have been administered with CLBR001 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLBR001 and SWI019 | Combination Product | No study drug is administered in this study. Patients who have received CLBR001 autologous CAR-T cells will be evaluated in this trial for long-term safety and efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and duration of new adverse events, late onset adverse events, and events of special interest | To measure the incidence and duration of new adverse events, late onset adverse events, and events of special interest | 15 years |
| Incidence and duration of new serious adverse events | To measure the incidence and duration of new serious adverse events | 15 years |
| Incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001 | The measure the incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001 | 15 years |
| Incidence of new malignancies | The measure the incidence of new malignancies | 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response | To evaluate clinical efficacy by measuring the overall response by Response Evaluation Criteria In Lymphoma (RECIL) 2017 | 15 years |
| Duration of response | To evaluate clinical efficacy by measuring the duration of response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| University of California at San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26759369 | Background | Rodgers DT, Mazagova M, Hampton EN, Cao Y, Ramadoss NS, Hardy IR, Schulman A, Du J, Wang F, Singer O, Ma J, Nunez V, Shen J, Woods AK, Wright TM, Schultz PG, Kim CH, Young TS. Switch-mediated activation and retargeting of CAR-T cells for B-cell malignancies. Proc Natl Acad Sci U S A. 2016 Jan 26;113(4):E459-68. doi: 10.1073/pnas.1524155113. Epub 2016 Jan 12. | |
| 30373813 |
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| 15 years |
| Progression free survival | To evaluate clinical efficacy by measuring progression free survival | 15 years |
| Proportion of patients undergoing stem cell transplant | To evaluate the proportion of patients undergoing stem cell transplant | 15 years |
| Number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens | To measure the number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens | 3, 6, 9,12 and 24 months |
| Detectable replication competent lentivirus (RCL) | To measure detectable replication competent lentivirus (RCL) | 15 years |
| Titer of anti-drug antibody (ADA) for CLBR001 and SWI019 | To evaluate immunogenicity by measuring the titer of ADA for CLBR001 and SWI019 | 3, 6, 12 months |
| Duration of detection of ADA for CLBR001 and SWI019 | To evaluate immunogenicity by measuring the duration of detection of ADA for CLBR001 and SWI019 | 3, 6, 12 months |
| San Diego |
| California |
| 92093 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Weill Cornell Medical College - New York Presbyterian Hospital | New York | New York | 10065 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| Sarah Cannon Research Institute - Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Sarah Cannon Research Institute - Texas Transplant Institute | San Antonio | Texas | 78229 | United States |
| Viaud S, Ma JSY, Hardy IR, Hampton EN, Benish B, Sherwood L, Nunez V, Ackerman CJ, Khialeeva E, Weglarz M, Lee SC, Woods AK, Young TS. Switchable control over in vivo CAR T expansion, B cell depletion, and induction of memory. Proc Natl Acad Sci U S A. 2018 Nov 13;115(46):E10898-E10906. doi: 10.1073/pnas.1810060115. Epub 2018 Oct 29. |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D020522 | Lymphoma, Mantle-Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| D002051 | Burkitt Lymphoma |
| D019337 | Hematologic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D009371 | Neoplasms by Site |
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