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This study was withdrawn (Sponsor decision).
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This is a Phase I study of FT596 in combination with two different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. The study will consist of a dose-escalation stage followed by a dose-expansion stage.
This is a Phase I study of FT596 in combination with 2 different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment.
The study will evaluate both the clinical benefit of FT596 when combined with R-CHOP given on a standard or alternate schedule.
Subjects will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage. After safety and tolerability have been assessed to define the maximum tolerated dose (MTD) (or the maximum assessed dose [MAD] in the absence of dose limiting toxicities [DLTs] defining the MTD) in the dose-escalation stage, the dose-expansion stage will further evaluate the safety and activity of FT596 in combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A (FT596 in combination with standard schedule R-CHOP) | Experimental | FT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles. |
|
| Regimen B (FT596 in combination with alternate schedule R-CHOP) | Experimental | FT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT596 | Drug | Dosing to be initiated at a dose no higher than highest tolerable dose in study FT596-101, intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicities within each dose escalation cohort | Day 21 | |
| Nature of dose-limiting toxicities within each dose escalation cohort | Day 21 | |
| Incidence, nature, and severity of adverse events (AEs) of FT596 in combination with R-CHOP in B-cell lymphoma previously untreated or no more than one previous line of therapy with severity determined according to NCI CTCAE, v5.0 | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed complete response (CR) | Proportion of subjects who achieve a complete response (CR) per Lugano 2014 classification | Up to 2 years |
| Investigator-assessed objective-response rate (ORR) |
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Key Inclusion Criteria:
Diagnosis of B-cell lymphoma (BCL) as described below:
Capable of giving signed informed consent
Age ≥ 18 years old
Stated willingness to comply with study procedures through study duration
Contraception use for women and men as defined in the protocol
Negative serum pregnancy test within 7 days of treatment for women
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fate Trial Disclosure | Fate Therapeutics | Study Director |
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Subjects will be assigned to one of 2 treatment regimens corresponding to different schedules (standard or alternate) of R-CHOP
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| Cyclophosphamide | Drug | 750 mg/m^2 intravenously |
|
| Doxorubicin | Drug | 50 mg/m^2 intravenously |
|
| Vincristine | Drug | 1.4 mg/m^2 (maximum dose 2 mg) intravenously |
|
| Prednisone | Drug | 100 mg orally |
|
| Rituximab | Drug | 375 mg/m^2 intravenously |
|
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| Bendamustine | Drug | 90 mg/m^2 IV infusion |
|
|
Proportion of subjects who achieve a partial response (PR) or complete response (CR) per Lugano 2014 classification
| Up to 2 years |
| Investigator-assessed duration of response (DOR) | Duration from the first occurrence of a documented objective response until the time of disease progression or relapse, or death from any cause, whichever occurs first, per Lugano 2014 classification | Up to 15 years |
| Investigator-assessed duration of complete response (DoCR) | Duration from the first occurrence of a documented complete response (CR), per Lugano 2014 classification until the time of disease progression or relapse, or death from any cause, whichever occurs first | Up to 15 years |
| Progression-free survival (PFS) | Time from first dose of study treatment to progressive disease (PD), or to the day of death for any reason, whichever occurs earlier, based on Lugano 2014 classification | Up to 15 years |
| Overall survival (OS) | Time from first dose of study treatment to death from any cause | Up to 15 years |
| Area Under the Plasma Concentration Time Curve (AUC) of FT596 | Assessed by the detection of FT596 in peripheral blood following FT596 administration. | Cycles 1-6 (each cycle is 28 days): Days 1,8,11,15,18; and Post-Treatment Week 1, Week 2, Week 4, and Week 8 |
| Maximum Plasma Concentration (Cmax) of FT596 | Assessed by the detection of FT596 in peripheral blood following FT596 administration. | Cycles 1-6 (each cycle is 28 days): Days 1,8,11,15,18; and Post-Treatment Week 1, Week 2, Week 4, and Week 8 |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| 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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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D000069283 | Rituximab |
| 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 |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring 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 |
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