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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05260957
Other study ID # 20210828
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 14, 2022
Est. completion date December 2027

Study information

Verified date January 2024
Source University of Miami
Contact Robby Friedman
Phone +1 (561) 7060311
Email rxf147@miami.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to test if a combination treatment of chimeric antigen receptor (CAR) T-cell therapy, Mosunetuzumab, and Polatuzumab Vedotin will result in tumor reduction.


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Study Design


Intervention

Drug:
Mosunetuzumab
Induction Phase (Days -42 through -7): 1 mg of Mosunetuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Day -42. 2 mg of Mosunetuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Day -35. 60 mg of Mosunetuzumab administered via intravenous (IV) infusion on (given as per treatment guidelines) on Days -28 and -7. Consolidation Phase (Day +1 through Day +90): 30 mg IV Mosunetuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Days +14, +35, +56 and +77.
Polatuzumab
Induction Phase (Days -42 through -7): 1.8mg/kg of Polatuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Day -28. Consolidation Phase (Days +1 through +90): 1.8mg/kg of Polatuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Days +35, +56 and +77.
Biological:
CAR-T Cell Therapy
Participants will receive CAR-T Cell therapy via infusion on Day 0 (given as per treatment guidelines). Prior to CAR-T Cell Therapy, participants will begin receiving lymphodepleting chemotherapy on Days -5 through -3 (given as per treatment guidelines).

Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
Lazaros Lekakis Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete Response Rate Complete Response (CR) rate will be reported as the percentage of participants achieving complete response (CR) to study treatment. Response to therapy will be assessed using Positron Emission Tomography (PET)/ Computerized Tomography (CT) scan following Lugano 2014 criteria (Cheson et al, Journal of Clinical Oncology (JCO), 2014) at 3 months (Day +90) of study treatment. For equivocal PET-CT results, biopsy will be performed after day +90 PET/CT to assess true CR or persistent lymphoma. 3 Months
Secondary Overall Response Rate (ORR) Overall response rate (ORR) will be reported as the percentage of participants achieving either complete response (CR) or partial response (ORR = CR + PR) to study treatment. Response to therapy will be assessed using Positron Emission Tomography (PET)/ Computerized Tomography (CT) scan following Lugano 2014 criteria (Cheson et al, Journal of Clinical Oncology (JCO), 2014) up to Day +90 of study treatment. Up to 3 months
Secondary Progression free survival (PFS) Rate PFS is defined as the elapsed time from the date of starting treatment to the date of progression, or date of death from any cause; whichever comes first. PFS rate will be reported as the percentage of participants without progressive disease after start of treatment. Up to 2 years
Secondary Overall Survival (OS) Rate Overall survival is defined as the elapsed time from the date of starting treatment to the date of death from any cause. OS rate will be reported as the percentage of participants still alive after start of treatment. Up to 2 years
Secondary Minimal residual disease (MRD) negativity Minimal residual disease (MRD) negativity will be reported as the percentage of participants showing absence of measurable disease in peripheral blood after start of CAR-T Cell therapy. MRD negativity will be assessed by using the Clustering and Alignment of Polymorphic Sequences (CAPSeq) assay. Up to 1 year
Secondary Duration of Response (DoR) Duration of response is defined as the elapsed time from date of complete response (CR) to the date of progression or death, whichever is first. DoR will be reported as the percentage of participants who relapsed after achieving CR on the Day +90 PET/CT scan. Relapse rate applies to unequivocal metabolic relapse or/and biopsy confirmed relapse among the patients who achieved CR on day +90 PET-CT Up to 2 years
Secondary Toxicity Rate of CAR-T Cell Therapy: ICANS Events Toxicity rate of CAR-T Cell Therapy will be reported as the percentage of participants with treatment-emergent Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS), after start of therapy, as evaluated by treating physician. The severity of ICANS events in participants will be assessed using American Society for Transplantation and Cellular Therapy (ASTCT) Consensus grading criteria (Lee et al, Biol Blood Marrow Transplant., 2019). Up to 6 months
Secondary Toxicity Rate of CAR-T Cell Therapy: CRS Events Toxicity rate of CAR-T Cell Therapy will be reported as the percentage of participants with treatment-emergent Cytokine Release Syndrome (CRS) events, after start of therapy, as evaluated by treating physician. The severity of CRS events in participants will be assessed using American Society for Transplantation and Cellular Therapy (ASTCT) Consensus grading criteria (Lee et al, Biol Blood Marrow Transplant., 2019). Up to 6 months
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