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The study was terminated by the Sponsor.
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This is a Phase I dose-finding study of FT596 as monotherapy and in combination with Rituximab or Obinutuzumab in subjects with relapsed/refractory B-cell Lymphoma or Chronic Lymphocytic Leukemia. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FT596 Monotherapy, Lymphoma | Experimental | FT596 monotherapy in adult subjects with r/r B-cell Lymphoma |
|
| FT596 in Combination with Rituximab, Lymphoma | Experimental | FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma |
|
| FT596 in Combination with Obinutuzumab, Lymphoma | Experimental | FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma |
|
| FT596 Monotherapy, CLL | Experimental | FT596 monotherapy in adult subjects with r/r CLL |
|
| FT596 in Combination with Obinutuzumab, CLL | Experimental | FT596 in combination with Obinutuzumab in adult subjects with r/r CLL |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT596 | Drug | Experimental Interventional Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicities within each dose level cohort | Day 29 | |
| Nature of dose-limiting toxicities within each dose level cohort | Day 29 | |
| Incidence, nature, and severity of adverse events (AEs) of FT596 as monotherapy and in combination with rituximab or obinutuzumab in r/r B-cell lymphomas and r/r chronic lymphocytic leukemia, with severity determined according to NCI CTCAE, v5.0 | Up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed objective-response rate (ORR) | Proportion of subjects who achieve a partial response (PR) or complete response (CR) per Lugano 2014 classification for lymphomas, a partial remission (PR) or complete remission (CR) per revised iwCLL guidelines for CLL. | From baseline tumor assessment up to approximately 2 years after last dose of FT596 |
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Key Inclusion Criteria:
Diagnosis of B-cell lymphoma or CLL as described below:
B-Cell Lymphoma:
Chronic Lymphocytic Leukemia (CLL):
ALL SUBJECTS:
Key Exclusion Criteria:
ALL SUBJECTS:
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| Name | Affiliation | Role |
|---|---|---|
| Fate Trial Disclosure | Fate Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States | ||
| University of Minnesota Masonic Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30082067 | Background | Li Y, Hermanson DL, Moriarity BS, Kaufman DS. Human iPSC-Derived Natural Killer Cells Engineered with Chimeric Antigen Receptors Enhance Anti-tumor Activity. Cell Stem Cell. 2018 Aug 2;23(2):181-192.e5. doi: 10.1016/j.stem.2018.06.002. Epub 2018 Jun 28. | |
| 39798981 | Derived | Ghobadi A, Bachanova V, Patel K, Park JH, Flinn I, Riedell PA, Bachier C, Diefenbach CS, Wong C, Bickers C, Wong L, Patel D, Goodridge J, Denholt M, Valamehr B, Elstrom RL, Strati P. Induced pluripotent stem-cell-derived CD19-directed chimeric antigen receptor natural killer cells in B-cell lymphoma: a phase 1, first-in-human trial. Lancet. 2025 Jan 11;405(10473):127-136. doi: 10.1016/S0140-6736(24)02462-0. |
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|
| Cyclophosphamide | Drug | Lympho-conditioning agent |
|
| Fludarabine | Drug | Lympho-conditioning agent |
|
| Rituximab | Drug | Monoclonal Antibody |
|
|
| Obinutuzumab | Drug | Monoclonal Antibody |
|
|
| Bendamustine | Drug | Conditioning agent |
|
|
| Investigator-assessed duration of objective response (DOR) | Defined as the duration from the first occurrence of a documented objective response (DOR) until the time of disease progression or relapse, or death from any cause, whichever occurs first, per Lugano 2014 classification for lymphomas or revised iwCLL guidelines for CLL. | Up to 15 years |
| Investigator-assessed duration of complete response (DoCR) | Defined as the duration from the first occurrence of a documented complete response (CR) per Lugano 2014 classification for lymphomas or complete remission (CR) per revised iwCLL guidelines for CLL, until the time of disease progression or relapse, or death from any cause, whichever occurs first. | Up to 15 years |
| Progression-free survival (PFS) | Defined as the time from from first dose of lympho-conditioning to progressive disease (PD), or to the day of death for any reason, whichever occurs earlier, based on Lugano 2014 classification for lymphomas or revised iwCLL guidelines for CLL | Up to 15 years |
| Overall survival (OS), defined as the time from first dose of lympho-conditioning to death from any cause. | Up to 15 years |
| The pharmacokinetics of FT596 in peripheral blood will be reported as the relative percentage of product (FT596) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points | Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29 |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Sarah Cannon Research Institute (Tennessee Oncology) | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| SCRI-TTI | San Antonio | Texas | 78229 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008223 | Lymphoma |
| D007938 | Leukemia |
| 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 |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D000069283 | Rituximab |
| C543332 | obinutuzumab |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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