Low-Dose TBI + CAR T-Cell Therapy for DLBCL and Multiple Myeloma
(Prime REMIX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a clinical trial to evaluate the safety of combining CAR T-cell therapy with low-dose total body irradiation (LD-TBI) in patients with previously treated large B-cell lymphoma (LBCL) or multiple myeloma (MM). The investigators' hypothesis is that the combination will make the immune system more active in fighting cancer by increasing the display of antigens and activating pathways that lead to cell death, including death receptors like FAS and TRAIL2. This approach is expected to help the CAR T cells grow and last longer, leading to stronger anti-tumor effects and more cancer cell deaths. Participants will receive LDTBI treatment before their CAR T cell therapy and will be followed up for 2 years.
Who Is on the Research Team?
Caitlin Gribbin, MD
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
This trial is for adults (18+) with relapsed or hard-to-treat large B-cell lymphoma or multiple myeloma who have already tried other treatments. Participants need to have good organ function and cannot join if they are pregnant, have certain infections, prior CAR T therapy, previous total body irradiation, or serious heart problems.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepletion and LD-TBI
Participants receive lymphodepletion followed by low-dose total body irradiation (LD-TBI) prior to CAR T-cell infusion
CAR T-cell Therapy
Participants receive commercial CD19 or BCMA-directed CAR T-cell therapy following LD-TBI
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Axicabtagene Ciloleucel
- Ciltacabtagene Autoleucel
- Lisocabtagene Maraleucel
- Low-Dose Total Body Irradiation
- Lymphodepleting chemotherapy: Bendamustine
- Lymphodepleting chemotherapy: Cyclophosphamide
- Lymphodepleting chemotherapy: Fludarabine
Trial Overview
The study tests the safety of combining low-dose total body irradiation with CAR T-cell therapy after chemotherapy in people with difficult-to-treat lymphoma or multiple myeloma. Patients get radiation before receiving one of several types of CAR T cells and are monitored for two years.
How Is the Trial Designed?
10
Treatment groups
Experimental Treatment
Expansion-cohort participants with relapsed/refractory multiple myeloma are randomized 1:1 to LD-TBI at the MTD or one dose level below. This arm receives LD-TBI at the MTD (single dose, Day 0), preceded by lymphodepletion and followed ≥4 hours later by commercial BCMA-directed CAR T-cell therapy.
Expansion-cohort participants with relapsed/refractory multiple myeloma are randomized 1:1 to LD-TBI at the MTD or one dose level below. This arm receives LD-TBI one dose level below the MTD (single dose, Day 0), preceded by lymphodepletion and followed ≥4 hours later by commercial BCMA-directed CAR T-cell therapy.
Expansion-cohort participants with relapsed/refractory LBCL are randomized 1:1 to LD-TBI at the MTD or one dose level below. This arm receives LD-TBI at the MTD (single dose, Day 0), preceded by lymphodepletion and followed ≥4 hours later by commercial CD19-directed CAR T-cell therapy.
Expansion-cohort participants with relapsed/refractory LBCL are randomized 1:1 to LD-TBI at the MTD or one dose level below. This arm receives LD-TBI one dose level below the MTD (single dose, Day 0), preceded by lymphodepletion and followed ≥4 hours later by commercial CD19-directed CAR T-cell therapy.
Participants with relapsed/refractory multiple myeloma receive lymphodepletion followed by LD-TBI 1.0 Gy (starting dose) on Day 0, ≥4 hours before infusion of commercial BCMA-directed CAR T-cell therapy.
Participants with relapsed/refractory multiple myeloma receive lymphodepletion followed by LD-TBI 0.5 Gy on Day 0, ≥4 hours before infusion of commercial BCMA-directed CAR T-cell therapy. Used if de-escalation from Dose Level 0 is required.
Participants with relapsed/refractory multiple myeloma receive lymphodepletion followed by LD-TBI 2.0 Gy on Day 0, ≥4 hours before infusion of commercial BCMA-directed CAR T-cell therapy. Used if Dose Level 0 is tolerated.
Participants with relapsed/refractory LBCL receive lymphodepletion followed by LD-TBI 1.0 Gy (starting dose) on Day 0, ≥4 hours before infusion of commercial CD19-directed CAR T-cell therapy.
Participants with relapsed/refractory LBCL receive lymphodepletion followed by LD-TBI 0.5 Gy on Day 0, ≥4 hours before infusion of commercial CD19-directed CAR T-cell therapy. Used if de-escalation from Dose Level 0 is required due to dose-limiting toxicity.
Participants with relapsed/refractory LBCL receive lymphodepletion followed by LD-TBI 2.0 Gy on Day 0, ≥4 hours before infusion of commercial CD19-directed CAR T-cell therapy. Used if Dose Level 0 is tolerated.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
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