A Phase 1 interventional study of FT596 and Rituximab in NHL, Non Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by Masonic Cancer Center, University of Minnesota · Phase 1, Interventional, and Treatment
This is a Phase I multi-center study to evaluate the safety of FT596 when given with rituximab as relapse prevention in patients who have undergone an autologous hematopoietic stem cell transplant (auto-HSCT) for diffuse large or high-grade B cell lymphoma.
This study uses a single dose of the investigational product FT596 in the early post-transplant period. Rituximab or an FDA approved by biosimilar including Rituxan®, Truxima®, and Ruxience™ is given 48 to 72 hours prior to FT596. The goal of this study is to 1) establish a maximum tolerated dose (MTD) of FT596 when given 30 days after transplant and 2) to confirm the MTD and safety of giving a single dose of FT596 at Day 7 post-transplant starting at one dose level below the MTD identified at Day 30.
5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 7 is below the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
High risk for relapse defined as at least one of the below:
Exclusion Criteria:
Post-HSCT Reconfirmation of eligibility
Adequate organ function post-transplant including:
Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10\^7 cells/dose, Dose Level 2: 3x10\^8 cells/dose, Dose Level 3: 9x10\^8 cells/dose with a Dose Level -1: 3x10\^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM).
Drug: FT596 · Drug: Rituximab
Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10\^7 cells/dose, Dose Level 2: 3x10\^8 cells/dose, Dose Level 3: 9x10\^8 cells/dose with a Dose Level -1: 3x10\^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM).
Drug: FT596 · Drug: Rituximab
Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10\^7 cells/dose, Dose Level 2: 3x10\^8 cells/dose, Dose Level 3: 9x10\^8 cells/dose with a Dose Level -1: 3x10\^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM).
Drug: FT596 · Drug: Rituximab
FT596 is given 2-3 days after rituximab; however, it may be delayed for up to 7 days until all rituximab infusion related toxicities resolve to ≤Grade 1.
Rituximab 375 mg/m\^2 is administered as an IV infusion per institutional standard of care and package insert on 2-3 days (48 to 72 hours) prior to the FT596 infusion
Also known as: Rituxan
Number of Participants Experiencing Dose Limiting Toxicity Events
The component I design (FT596 on day 30) will continue until the MTD is declared or until the first dose is declared to be above MTD. The component I dose limiting toxicity (DLT) is defined as any of the following events within 28 days after the FT596 dosing based on CTCAE v5:Grade 4 hematologic toxicity lasting \> 7 days ,Grade 4 non-hematologic toxicity ,Grade ≥3 Infusion Related Reaction, Grade 2 acute GVHD that requires steroid therapy \>7 days or progression after 3 days of steroids or has partial response after 14 days of treatment, Grade ≥3 acute GVHD, Grade 4 cytokine release syndrome (CRS), Grade 3 CRS that does not resolve to \< Grade 2 in 72 hours, Grade 3 neurotoxicity, Grade 3 organ toxicity involving vital organs, Any Grade 3 non-hematological toxicity that does not resolve to ≤Grade 2 within 72 hours
Time frame: 28 Days Post FT596 infusion
Number of Participants Experiencing Adverse Events
Number of participants experiencing adverse events related to FT596 post auto-HSCT in combination with rituximab
Time frame: 1 year post FT596 infusion
Percentage of Participants With Relapse/Progression
Percentage of participants experiencing progression or relapse at 12 months post auto HSCT
Time frame: 1 year post auto HSCT
Number of Participants Experiencing Non-relapse Mortality Incidents at 100 Days Post HSCT
Number of participants experiencing non-relapse mortality at 100 days post auto-HSCT.
Time frame: 100 days post HSCT
Percentage of Non-relapse Mortality Incidents at One Year Post HSCT
Percentage of participants experiencing non-relapse mortality at one year post auto-HSCT.
Time frame: one year post auto-HSCT
Progression-Free Survival 12 Months Post Auto-HCT
Progression-Free Survival 12 Months Post Auto-HCT
Time frame: 12 Months Post Auto-HCT
| Milestone | FT596 + Rituximab Dose Level 1: 9x10^7 Cells/Dose | FT596 + Rituximab Dose Level 2: 3x10^8 Cells/Dose | FT596 + Rituximab Dose Level 3: 9x10^8 Cells/Dose |
|---|---|---|---|
| Started | 3 | 3 | 1 |
| Completed | 3 | 3 | 1 |
| Not completed | 0 | 0 | 0 |
The component I design (FT596 on day 30) will continue until the MTD is declared or until the first dose is declared to be above MTD. The component I dose limiting toxicity (DLT) is defined as any of the following events within 28 days after the FT596 dosing based on CTCAE v5:Grade 4 hematologic toxicity lasting \> 7 days ,Grade 4 non-hematologic toxicity ,Grade ≥3 Infusion Related Reaction, Grade 2 acute GVHD that requires steroid therapy \>7 days or progression after 3 days of steroids or has partial response after 14 days of treatment, Grade ≥3 acute GVHD, Grade 4 cytokine release syndrome (CRS), Grade 3 CRS that does not resolve to \< Grade 2 in 72 hours, Grade 3 neurotoxicity, Grade 3 organ toxicity involving vital organs, Any Grade 3 non-hematological toxicity that does not resolve to ≤Grade 2 within 72 hours
| Participants | FT596 + Rituximab Dose Level 1: 9x10^7 Cells/Dose | FT596 + Rituximab Dose Level 2: 3x10^8 Cells/Dose | FT596 + Rituximab Dose Level 3: 9x10^8 Cells/Dose |
|---|---|---|---|
| Number of Participants Experiencing Dose Limiting Toxicity Events | 0 | 0 | 0 |
Number of participants experiencing adverse events related to FT596 post auto-HSCT in combination with rituximab
| participants | FT596 + Rituximab Dose Level 1: 9x10^7 Cells/Dose | FT596 + Rituximab Dose Level 2: 3x10^8 Cells/Dose | FT596 + Rituximab Dose Level 3: 9x10^8 Cells/Dose |
|---|---|---|---|
| Number of Participants Experiencing Adverse Events | 3 | 0 | 1 |
Percentage of participants experiencing progression or relapse at 12 months post auto HSCT
| Percentage of participants | FT596 + Rituximab Dose Level 1: 9x10^7 Cells/Dose | FT596 + Rituximab Dose Level 2: 3x10^8 Cells/Dose | FT596 + Rituximab Dose Level 3: 9x10^8 Cells/Dose |
|---|---|---|---|
| Percentage of Participants With Relapse/Progression | 67 (22 to 100) | 33 (0 to 77) | 0 (0 to 100) |
Number of participants experiencing non-relapse mortality at 100 days post auto-HSCT.
| Participants | FT596 + Rituximab Dose Level 1: 9x10^7 Cells/Dose | FT596 + Rituximab Dose Level 2: 3x10^8 Cells/Dose | FT596 + Rituximab Dose Level 3: 9x10^8 Cells/Dose |
|---|---|---|---|
| Number of Participants Experiencing Non-relapse Mortality Incidents at 100 Days Post HSCT | 0 | 0 | 0 |
Percentage of participants experiencing non-relapse mortality at one year post auto-HSCT.
| Percentage of participants | FT596 + Rituximab Dose Level 1: 9x10^7 Cells/Dose | FT596 + Rituximab Dose Level 2: 3x10^8 Cells/Dose | FT596 + Rituximab Dose Level 3: 9x10^8 Cells/Dose |
|---|---|---|---|
| Percentage of Non-relapse Mortality Incidents at One Year Post HSCT | 67 (5 to 95) | 100 (0 to 100) | 100 (0 to 100) |
Progression-Free Survival 12 Months Post Auto-HCT
| Percentage of participants | FT596 + Rituximab Dose Level 1: 9x10^7 Cells/Dose | FT596 + Rituximab Dose Level 2: 3x10^8 Cells/Dose | FT596 + Rituximab Dose Level 3: 9x10^8 Cells/Dose |
|---|---|---|---|
| Progression-Free Survival 12 Months Post Auto-HCT | 33 (1 to 77) | 67 (5 to 95) | 100 (0 to 100) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FT596 + Rituximab Dose Level 1: 9x10^7 Cells/Dose | 2/3 (66.7%) | 0/3 (0%) | 3/3 (100%) |
| FT596 + Rituximab Dose Level 2: 3x10^8 Cells/Dose | 3/3 (100%) | 0/3 (0%) | 0/3 (0%) |
| FT596 + Rituximab Dose Level 3: 9x10^8 Cells/Dose | 1/1 (100%) | 0/1 (0%) | 1/1 (100%) |
| Event | FT596 + Rituximab Dose Level 1: 9x10^7 Cells/Dose | FT596 + Rituximab Dose Level 2: 3x10^8 Cells/Dose | FT596 + Rituximab Dose Level 3: 9x10^8 Cells/Dose |
|---|---|---|---|
| Lung InfectionInfections and infestations | 0/3 | 0/3 | 1/1 |
| AnemiaBlood and lymphatic system disorders | 2/3 | 0/3 | 0/1 |
| FatigueGeneral disorders | 2/3 | 0/3 | 0/1 |
| DiarrheaGastrointestinal disorders | 2/3 | 0/3 | 0/1 |
| Lymphocyte count decreasedInvestigations | 1/3 | 0/3 | 0/1 |
| SinusitisInfections and infestations | 1/3 | 0/3 | 0/1 |
| HeadacheNervous system disorders | 1/3 | 0/3 | 0/1 |
| NauseaGastrointestinal disorders | 1/3 | 0/3 | 0/1 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/3 | 0/3 | 0/1 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/3 | 0/3 | 0/1 |
| Age, Categorical(Participants) | FT596 + Rituximab Dose Level 1: 9x10^7 Cells/Dose | FT596 + Rituximab Dose Level 2: 3x10^8 Cells/Dose | FT596 + Rituximab Dose Level 3: 9x10^8 Cells/Dose | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 2 | 1 | 5 |
| >=65 years | 1 | 1 | 0 | 2 |
| Sex: Female, Male(Participants) | FT596 + Rituximab Dose Level 1: 9x10^7 Cells/Dose | FT596 + Rituximab Dose Level 2: 3x10^8 Cells/Dose | FT596 + Rituximab Dose Level 3: 9x10^8 Cells/Dose | Total |
|---|---|---|---|---|
| Female | 1 | 0 | 0 | 1 |
| Male | 2 | 3 | 1 | 6 |
| Ethnicity (NIH/OMB)(Participants) | FT596 + Rituximab Dose Level 1: 9x10^7 Cells/Dose | FT596 + Rituximab Dose Level 2: 3x10^8 Cells/Dose | FT596 + Rituximab Dose Level 3: 9x10^8 Cells/Dose | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 3 | 1 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | FT596 + Rituximab Dose Level 1: 9x10^7 Cells/Dose | FT596 + Rituximab Dose Level 2: 3x10^8 Cells/Dose | FT596 + Rituximab Dose Level 3: 9x10^8 Cells/Dose | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 2 | 2 | 1 | 5 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 0 | 1 |
| Region of Enrollment(participants) | FT596 + Rituximab Dose Level 1: 9x10^7 Cells/Dose | FT596 + Rituximab Dose Level 2: 3x10^8 Cells/Dose | FT596 + Rituximab Dose Level 3: 9x10^8 Cells/Dose | Total |
|---|---|---|---|---|
| United States | 3 | 3 | 1 | 7 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Masonic Cancer Center, University of Minnesota