Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients (NCT04634435) | Clinical Trial Compass
CompletedPhase 1
Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients
United States7 participantsStarted 2021-10-21
Plain-language summary
This is an open-label single center Phase 1a/1b study with the primary objective of establishing the safety and exploring the efficacy of infusing the ex vivo combination product of BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2 in the peri-transplant setting in MM patients with minimal residual disease (MRD+) in first or second remission.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Had measurable disease according to Standard Diagnostic Criteria at the time of initial Multiple Myeloma diagnosis
* Meets criteria for symptomatic multiple myeloma at the time of induction chemotherapy
* Is transplant eligible based on clinician judgement
* Willing to undergo ASCT in first or second remission
* Achieve partial response or better with induction chemotherapy prior to ASCT according to the IMWG Uniform Response Criteria for Multiple Myeloma
* Be MRD+ upon restaging prior to stem cell collection and ASCT
* Eastern Cooperative Oncology Group (EGOG) performance status score of less than 2
* Life expectancy greater than six months
* Have a creatinine clearance \> 45 mL/min/m2 at the time of transplant evaluation
* If frozen stem cells from earlier mobilized leukapheresis are unavailable at the time of mobilized leukapheresis, patients must meet parameters/criteria according to institutional SOP for autologous stem cell apheresis
* Be willing and clinically stable to undergo stem-cell mobilized and collect enough CD34+ cells sufficient for 2 ASCT per institutional guidelines or investigator discretion or have sufficient frozen cells from a SoC collection prior to signing study consent
* Be willing and clinically stable to undergo a non-mobilized MNC-Apheresis while admitted to the hospital to generate CIML NK cells
* Be willing to undergo maintenance after ASCT per NCCN guidelines based on disease risk
* If a woman of child-bearing potential, …
What they're measuring
1
Dose limiting toxicities following Combination Product administration
Timeframe: 90-100 days post Combination Product administration
2
Incidence and severity of side effects related to the Combination Product
Timeframe: 90-100 days post Combination Product administration