Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL) UNIVERSAL
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What's the purpose of this trial?

The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 with or without Nirogacestat in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen of ALLO-647 in combination with fludarabine and/or cyclophosphamide, or ALLO-647 alone.

This trial is currently open and accepting patients.


What will happen during the trial?

The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 with or without Nirogacestat in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen of ALLO-647 in combination with fludarabine and/or cyclophosphamide, or ALLO-647 alone.

Additional Trial Information

Phase 1

Enrollment: 132 patients (estimated)

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Published Results

Allogene Therapeutics Reports Positive Results from Phase 1 UNIVERSAL Study of Single Dose ALLO-715 AlloCAR Tâ„¢ Cell Therapy in Relapsed/Refractory Multiple Myeloma at the 63rd American Society of Hematology Annual Meeting

December 13, 2021

As of the October 14, 2021 data cutoff, 48 patients were enrolled with 43 patients evaluable for safety and efficacy. Patients were refractory to their last line of myeloma therapy, had a median of five prior lines of therapy, and 42% were penta-refractory meaning the disease has ultimately become nonresponsive to other approved therapies. Five patients became ineligible for treatment due to rapidly progressing disease. The median time from enrollment to the start of therapy was five days.

The Phase 1 UNIVERSAL trial evaluated lymphodepletion followed by ALLO-715 at one of four dose levels (DL1=40M cells, DL2=160M cells, DL3=320M cells, DL4 = 480M cells) and two LD regimens (FCA: fludarabine, cyclophosphamide and ALLO-647 or CA: cyclophosphamide and ALLO-647 only). The updated presentation primarily focuses on the optimized DL3 cell dose and FCA lymphodepletion.

The higher CAR T cell doses were associated with an increased response rate and greater AlloCAR T cell expansion. In the DL3 cohort which was selected for cohort expansion, the overall response rate (ORR) increased from 60% reported at ASH 2020 to 71% with 46% of patients achieving a very good partial response (VGPR) or better (VGPR+) up from 40%. VGPR+ is defined as a stringent complete response (sCR), complete response (CR) or VGPR. Of the patients who achieved VGPR+, 92% were Minimal Residual Disease (MRD) negative.

As of the data cutoff, the overall median follow-up for efficacy was 3.8 months. The median duration of response is 8.3 months, with nine patients remaining in ongoing response at the time of the data cut-off. The longest ongoing response after cell infusion is 12 months. Results showed that soluble BCMA levels were 10 times lower in responders at Day 28, suggesting soluble BCMA suppression is associated with response.

Of the 43 patients evaluable for safety, there was no graft-versus-host-disease (GvHD). Grade 1 and 2 cytokine release syndrome (CRS) was reported in 23 patients (53%) and was manageable with standard therapies. In this heavily pre-treated patient population, infection occurred in 54% of patients, which included three Grade 5 infections, two of which were previously reported. Grade 3+ neutropenia occurred in 70% of patients. Six patients (14%) experienced adverse events of low-grade neurotoxicity, which was reversible. Use of tocilizumab and steroids was infrequent (23% and 14%, respectively).

Off-the-Shelf CAR Therapy Shows Early Promise in Multiple Myeloma

December 05, 2020

ALLO-715, an off-the-shelf chimeric antigen receptor (CAR) T-cell therapy that targets B-cell maturation antigen (BCMA), elicited responses in heavily pretreated patients with relapsed/refractory multiple myeloma in early findings from a first-in-human study presented at the 2020 ASH Meeting.

The therapy generated responses in 6 of 10 patients (60%), including a very good partial-plus response (VGPR+) in 4 patients (40%), who were treated with ALLO-715 at a dose of 320 x 106 CAR cells plus a lymphodepleting regimen that included ALLO-647, an anti-CD52 monoclonal antibody, during the ongoing phase 1 UNIVERSAL study (NCT04093596).

Trial Locations

All Trial Locations

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Arizona

Banner - University Medical Center Tucson Banner Health

Tucson, AZ

Open and Accepting

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

Stanford Cancer Institute (Palo Alto)

Stanford, CA

Open and Accepting

Colorado

Massachusetts

Massachusetts General Hospital

Boston, MA

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Ohio

Cleveland Clinic Taussig Cancer Institute

Cleveland, OH

Open and Accepting

Tennessee

Vanderbilt-Ingram Cancer Center Henry-Joyce Cancer Clinic

Nashville, TN

Open and Accepting

Texas

St. David's South Austin Medical Center

Austin, TX

Open and Accepting

Methodist Hospital

San Antonio, TX

Open and Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting

Trial Links

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