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This is a phase 1 study of FT522 administered with rituximab in participants with relapsed/refractory B-cell lymphoma (R/R BCL). The primary objectives of the study are to evaluate the safety and tolerability of FT522 in combination with rituximab, and to determine the recommended phase 2 dose (RP2D) of FT522 in combination with rituximab; each objective will be assessed with or without conditioning chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental | Participants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) with chemotherapy. |
|
| Regimen B | Experimental | Participants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) without chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT522 | Drug | FT522 drug product is administered as an intravenous infusion on Days 1, 4 and 8 of a treatment cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose limiting toxicities (DLTs) | The number of participants experiencing ≥1 DLT will be reported. | From Day 1 through Day 29 of Cycle 1 |
| Severity of DLTs | The severity of DLTs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, v5.0). | From Day 1 through Day 29 of Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Participants will be classified into the following tumor response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE) according to the Lugano 2014 criteria. The best overall response (BOR) will be summarized for the efficacy evaluable population. ORR is defined as the percentage of participants who achieve a PR or better during the study prior to any subsequent off-protocol anti-cancer therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Fate Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advent Health | Orlando | Florida | 32803 | United States | ||
| Karmanos Cancer Center |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Participants will be enrolled first into a dose-escalation stage, followed by a dose optimization stage, and a dose-expansion stage.
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The initial dose escalation stage of the study is nonrandomized; the dose optimization stage is randomized; the dose expansion stage is nonrandomized.
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| Rituximab | Drug | Rituximab will be administered as an IV infusion on Day -4 of the treatment cycle. |
|
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| Cyclophosphamide | Drug | Cyclophosphamide will be administered as an IV infusion at a dose of 500 mg/m^2 on Day -5, Day -4, and Day -3 of the treatment cycle. |
|
| Fludarabine | Drug | Fludarabine will be administered as an IV infusion at a dose of 30 mg/m^2 on Day -5, Day -4, and Day -3 of the treatment cycle. |
|
| Bendamustine | Drug | Bendamustine will be administered as an IV infusion at a dose of 90 mg/m^2 on Day -5 and Day -4 of the treatment cycle. Bendamustine may be administered as an alternative to cyclophosphamide/fludarabine. |
|
| Up to approximately 24 months |
| Duration of Response (DOR) | The DOR is defined as the time from first objective response to disease progression or death from any cause. | Up to approximately 18 months |
| Duration of Complete Response (DOCR) | The DOCR is defined as the time from first CR to disease progression or death from any cause. | Up to approximately 18 months |
| Progression-Free Survival (PFS) | PFS is defined as the time from first study intervention to progressive disease or death from any cause. | Up to approximately 18 months |
| Overall Survival (OS) | OS is defined as the time from first dose of study intervention to death from any cause. | Up to approximately 18 months |
| Area Under the Plasma-Concentration Time Curve (AUC) of FT522 | The plasma AUC of FT522 will be reported. | Cycle 1, Up to Day 29 |
| Maximum Plasma Concentration (Cmax) of FT522 | The plasma Cmax of FT522 will be reported. | Cycle 1, Up to Day 29 |
| Detroit |
| Michigan |
| 48201 |
| United States |
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Baylor Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |