Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Paolo Caimi, MD
Study ID
NCT07225439
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • B-cell Non Hodgkin Lymphoma
  • Chronic Lymphocytic Leukemia
  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma
  • High-grade B-cell Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Non Hodgkin Lymphoma
  • Primary Mediastinal Large B Cell Lymphoma
  • Small Lymphocytic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic NK cells — DRUG
    Allogeneic NK cells are given intravenously (IV) weekly for 3 weeks on Days 0, 7, 14. Dose escalation will be conducted using a Bayesian optimal interval (BOIN) design starting at dose level 1 (500 x 106 cells) and proceeding to dose level 2 (1,000 x 106 cells) if criteria are met.
  • Rituximab — DRUG
    Rtx is dosed at 375mg/m2 and give once (on Day -5 for Cycle 1 and Day 0 for Cycle 2, if applicable).
  • Tafasitamab — DRUG
    Tafasitamab is dosed at 12 mg/kg and given intravenously (IV) weekly for 3 weeks on Days 0,7,14).
  • Interleukin-2 — DRUG
    Interleukin-2 is dosed at 5 million IU and given weekly for 3 weeks on Days 0,7,14.
  • Fludarabine/cyclophosphamide — DRUG
    Fludarabine is dosed at 30 mg/m2/d with dose adjustment for renal function, and cyclophosphamide is dosed at 500 mg/m2/d. These are given on 3 days (Days -5 to -3).

Study Details

This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma. NK cells are an investigational (experimental) treatment which means they are not approved by the Food and Drug Administration (FDA). NK cells are a type of lymphocyte that's part of the body's natural immune system, and they can kill cancer cells by creating pores in the cancer cell membranes and inducing apoptosis (programmed cell death). Participants in this study will receive lymphodepleting chemotherapy, as well as Allogeneic NK cells, Tafasitamab and Interleukin-2 (IL-2) by an intravenous (IV) infusion. Participants are expected to complete one cycle, and they may be eligible to complete a second cycle of the same regiment if they have stable disease, partial or complete remission at the end of the first cycle. Participants will be in this study for about 12 months.

Key Dates

Start date
Dec 31, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rtx + Tafasitamab in combination with allogeneic NK Cells
    This arm includes dose escalation for allogeneic NK cells. All other therapies are given according to standard of care. The length of the treatment period is 28 days per cycle. Participants will be expected to complete one cycle and may have the option to complete a second cycle unless there is evidence of disease progression at the end of the first cycle.

Primary Outcome Measure

Dose limiting toxicity (DLT) [ Time Frame: Up to 42 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer InstituteClevelandOhio44195
Paolo Caimi, MD
[email protected]
Paolo Caimi, MD (PRINCIPAL_INVESTIGATOR)
Case Comprehensive Cancer Center, University Hospitals Seidman Cancer CenterClevelandOhio44106
Changchun (George) Deng
[email protected]
Changchun (George) Deng, MD (PRINCIPAL_INVESTIGATOR)

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Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute· Cleveland, OHCase Comprehensive Cancer Center, University Hospitals Seidman Cancer Center· Cleveland, OH

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