BCMA-directed CAR-T Cell Therapy in Adult Patients With Relapsed and/or Refractory Multiple Myeloma PHE885

What's the purpose of this trial?

This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a novel B-cell Maturation Antigen (BCMA)-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells will be investigated as a single agent in relapsed/refractory multiple myeloma.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Subjects with MM who are relapsed and/or refractory to at least 2 prior treatment regimens, including an IMiD (e.g. lenalidomide or pomalidomide), a proteasome inhibitor (e.g. bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g. daratumumab), if available, and have documented evidence of disease progression (IMWG criteria)
  • Measurable disease as defined by the protocol
  • ECOG performance status that is either 0 or 1 at screening
  • Adequate hematological values
  • Must have a leukapheresis material of non-mobilized cells accepted for manufacturing

Exclusion Criteria:

  • Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy. Patients who have received prior BCMA-directed bi-specific antibodies or antibody-drug conjugates (ADC) are not excluded.
  • Autologous HSCT within 6 weeks prior to enrollment or any prior history of allogeneic hematopoietic stem cell transplant (HSCT)
  • Chemotherapy or any concomitant anti-cancer therapies (other than protocol prescribed lymphodepletion (LD) chemotherapy) within 2 weeks prior to apheresis
  • Treatment with small molecule targeted antineoplastics within 2 weeks of apheresis collection or 5 half-lives whichever is shorter
  • Have received antibodies or immunotherapies (other than daratumumab) within 4 weeks prior to apheresis collection. Daratumumab within 3 weeks prior to apheresis collection.

Additional Trial Information

Phase 1

Enrollment: 96 patients (estimated)

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Published Results

Updated phase I study results of PHE885, a T-Charge manufactured BCMA-directed CAR-T cell therapy, for patients (pts) with r/r multiple myeloma (RRMM).

December 22, 2022

As of December 22, 2022, 46 pts received PHE885 at the following doses: 2.5e6 (n=4), 5e6 (n=13), 10e6 (n=20), 14.3e6 (n=1), and 20e6 (n=8) CAR T cells. PHE885 was manufactured for 61% of pts at a single academic institution; these pts proceeded from apheresis to LD in a median of 16 days. Median age at enrollment was 65 y (range [R] 45-81), median prior lines of tx was 4 (R 2-10). 37% of pts had extramedullary disease; 96% were triple refractory. Despite aggressive disease, only 28% of pts required bridging chemotherapy, predominantly influenced by quick production time. 96% of pts experienced any gr cytokine release syndrome (CRS); 11% had gr 3 CRS. Median time to CRS onset was 8 (R 2-16) days and median duration was 4 (R 1-19) days. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 22% of pts; 7% had gr 3 ICANS. Dose limiting toxicities were experienced by 13% of pts and included gr 4 neutropenia, gr 4 lipase increase, gr 3 serum amylase increase, gr 3 neurotoxicity, gr 3 transaminitis, and gr 3 ejection fraction reduction. The most common tx-related gr ≥3 AEs included anemia (54%), neutropenia (50%), and thrombocytopenia (37%). Geo-mean peak PHE885 expansion (Cmax) was 276,000 copies/µg by qPCR and 70.6% of CD3+ T cells by flow cytometry (n=41). The PHE885 transgene was detected in 13/14 (93%) pts at 6 mo and 5/7 (71%) at 12 mo post infusion. T cells with early memory phenotype were preserved in the final product and persisted in pts post infusion. In 43 efficacy-evaluable pts, the ORR was 98%. At 10e6 dose (n=19), ORR was 100% and CRR was 42% (median follow-up of 4.9 mo [R 1.4-11.8]); 60% of 10 evaluable pts were MRD negative at 10-5 by NGS. Initial efficacy data at 20e6 and longer follow-up at active doses will also be presented.

Novartis announces T-Charge™, next-generation CAR-T platform with first-in-human data at ASH 2021

December 13, 2021

PHE885, an investigational, autologous BCMA-directed CAR-T cell therapy developed using the T-Charge platform, demonstrated promising results in patients with relapsed or refractory multiple myeloma in a first-in-human Phase I, multicenter, dose-escalation study. Fifteen patients were evaluated for efficacy and safety and the fixed doses received were 2.5×106 (n=4), 5×106 (n=10) and 14.3×106 CAR-T cells (n=1). Although the follow-up period was brief, PHE885 shows encouraging initial clinical activity with a best overall response of 100% for patients receiving the 5×106 or 14.3×106 CAR-T cell dose, with responses deepening over time. With a median follow-up of 3.5 months, eight of 15 patients had ongoing responses at the time of data cutoff. Of the evaluable patients at three months post administration, 34% (2/6) were MRD-negative by next-generation sequencing (NGS) at 10-6; 43% (3/7) were MRD-negative at 10-5.

All patients experienced CRS with two patients experiencing grade ≥3 CRS. No patients experienced grade 4 or 5 CRS. All neurotoxicity events (n=4) were nonserious, grade 1-2, reversible, and temporally associated with CRS.

Trial Locations

All Trial Locations

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University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Open and Accepting


University of Kansas Cancer Center (Westwood)

Westwood, KS

Open and Accepting


Dana-Farber Cancer Institute (Main)

Boston, MA

Open and Accepting

Beth Israel Deaconess Medical Center

Boston, MA

Open and Accepting


Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Open and Accepting


Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting
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