FT596 + Rituximab for Lymphoma Relapse Prevention

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byDr.Veronika Bachanova, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Masonic Cancer Center, University of Minnesota

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Dr.Veronika Bachanova, MD, PhD

Principal Investigator

Masonic Cancer Center, University of Minnesota

Eligibility Criteria

This trial is for adults over 18 with diffuse large B cell lymphoma or high-grade B-cell lymphoma, who've had or are planning an autologous stem cell transplant. Participants must agree to long-term follow-up and contraception, have no severe ongoing health issues, no active infections, and meet specific organ function criteria post-transplant.

Inclusion Criteria

No life-threatening medical issues (i.e. ongoing Grade 4 adverse events) where, in the opinion of the treating investigator, use of FT596 is not in the patient's best interest.

Adequate organ function post-transplant including: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 x ULN (Grade 2 CTCAE v5) total bilirubin ≤1.5 x ULN (Grade 1 CTCAE v5) serum creatinine ≤1.5 x ULN (Grade 1 CTCAE v5) oxygen saturation ≥93% on room air For Day 30 dosing only - CBC requirement consistent with engraftment (ANC>500, platelet>20,000 without transfusion support within previous 7 days). There are no CBC parameters for Day 7 dosing.

High risk for relapse defined as at least one of the below: Primary induction failure (no complete or partial remission at any point after diagnosis Initial remission duration < 12 months Lack of complete metabolic (PET scan) response after 2-3 cycles of salvage chemotherapy Evidence of c-myc and bcl-2 and/or bcl-6 re-arrangement (double hit or triple hit lymphoma) Age-adjusted IPI 2-3 at relapse Age 18 years or older at the time of signing consent.

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Exclusion Criteria

Seropositive for HIV, active Hepatitis B or C infection with detectable viral load by PCR

Body weight <50kg

You have not participated in any experimental treatment within 28 days before starting FT596 or planned to do so within the first 100 days after transplant.

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Treatment Details

Interventions

FT596 (CAR T-cell Therapy)
Rituximab (Monoclonal Antibodies)

Trial OverviewThe study tests the safety of a new therapy called FT596 in combination with Rituximab to prevent relapse after an autologous hematopoietic stem cell transplant in patients with certain types of aggressive B-cell lymphomas.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: FT596 + Rituximab Dose Level 3: 9x10^8 cells/doseExperimental Treatment2 Interventions

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).

Group II: FT596 + Rituximab Dose Level 2: 3x10^8 cells/doseExperimental Treatment2 Interventions

Group III: FT596 + Rituximab Dose Level 1: 9x10^7 cells/doseExperimental Treatment2 Interventions