SUZHOU and SHANGHAI, China,
Dec. 5, 2020 /PRNewswire/
-- Gracell Biotechnologies Inc. ("Gracell"), a global
clinical-stage biopharmaceutical company dedicated to developing
highly efficacious and affordable cell therapies for the treatment
of cancer, today announced an interim readout to evaluate the
safety and efficacy of its potential first-in-class GC012F
FasTCAR-enabled dual-targeting BCMA/CD19 cell therapy in patients
with relapsed or refractory multiple myeloma (R/R MM). The data
were presented by Dr. Weijun Fu,
Professor of Hematology, Director at Shanghai Changzheng Hospital,
as an oral presentation at the American
Society of Hematology's (ASH) 2020 Annual Meeting.
GC012F, a dual BCMA/CD19 targeting CAR-T cell therapy developed
on Gracell's FasTCAR platform - which enables next-day
manufacturing - was evaluated in an investigator-initiated Phase 1
trial. As of July 17th,
the study enrolled sixteen patients at three dose levels
with the highest dose level of
3x10^5 cells per kg. After three days of a standard lymphodepleting
regimen, patients received GC012F as a single infusion over 30
minutes.
- Early Overall Response Rate (ORR) showed a promising 93.7% with
all responses being VGPR or better - showing fast, deep and durable
responses in all dose levels
- 100% of the patients treated at the highest dose level (n=6)
obtained a MRD negative sCR which was maintained through the
landmark analysis of six months (n=4) at the time of data cut off
The median duration of follow up
at time of assessment was 7.3 months (range 1–10 months). Of the
sixteen patients treated, 93.7% were classified as high-risk
according to mSMART 3.0 guidelines, 19% had double hit R/R MM, and
31% had extramedullary disease. Patients had received a median of 5
prior lines of therapy, with 75% being refractory to last therapy
and 19% being primary refractory. 94% of the patients were triple
exposed to a PI, IMiD, and at least a third treatment modality,
including anti-CD38 targeted therapy. 63% were penta-exposed with
at least five different treatment modalities, including PI, IMiD
and others. One patient with extramedullary disease obtained MRD negative result at his first
bone marrow assessment at month 1, however, he was considered a
non-responder based on the increasing size of the extramedullary
lesion at month 1.
The safety profile of GC012F was manageable with an overall low
grade of cytokine release syndrome (CRS) (87.5 % Grade 1/2, 2
patients Grade 3, no Grade 4 or 5) and a median duration of four
days ranging from 1–8 days. CRS was treated with Standard of Care
treatment, including tocilizumab and steroids, and resolved in all cases. No ICANS
(immune effector cell-associated neurotoxicity) was observed in any
of the sixteen patients. Treatment-emergent adverse events (TEAEs)
presented predominantly as cytopenias and AST increase. Lower
respiratory tract infection was observed in three patients. All
TEAEs were resolved with standard therapy.
"We are extremely encouraged about these early findings in
sixteen patients with predominately high-risk features," said Dr.
Martina Sersch, MD, PhD, CMO of
Gracell. "High-risk patients are difficult to treat successfully
and to achieve longer-term
remission. A 100% MRD-sCR at month six post-infusion after
treatment with GC012F at the highest dose level shows promise for
heavily pretreated patients who have failed or were no longer
responding to standard treatment options. We are planning to expand
our program globally and are looking forward to sharing updates as
we advance our programs through clinical development."
About Gracell
Gracell Biotechnologies Inc. ("Gracell") is a global
clinical-stage biopharmaceutical company dedicated to discovering
and developing breakthrough cell therapies. Leveraging its
pioneering FasTCAR and TruUCAR technology platforms, Gracell is
developing a rich clinical-stage pipeline of multiple autologous
and allogeneic product candidates with the potential to overcome
major industry challenges that persist with conventional CAR-T
therapies, including lengthy manufacturing time, suboptimal
production quality, high therapy cost and lack of effective CAR-T
therapies for solid tumors.
Media contact
Linc He
Linc.he@gracellbio.com
+86-21-6403-1375
Investor contact
Gracie
Tong
Gracie.tong@gracellbio.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/gracell-biotechnologies-announces-presentation-of-first-in-human-data-of-gc012f-a-first-in-class-fastcar-enabled-dual-targeting-bmcacd19-car-t-cell-therapy-for-patients-with-relapsed-or-refractory-multiple-myeloma-at-2020-ash-ann-301186804.html
SOURCE Gracell