Allogeneic, off-the-shelf CAR-T therapy with CD19/CD7 dual-directed CAR shows promising early results in patients with r/r B-ALL
GC502 leverages the novel dual-directed CAR design of Gracell's proprietary TruUCAR platform, designed to generate high-quality allogeneic CAR-T cell therapies that can be administered "off-the-shelf" at lower cost and with faster patient's access. TruUCAR-enabled GC502 utilizes the dual-directed CAR design with one CAR targeting CD19 on malignant cells and a second CAR targeting CD7 to suppress host-versus-graft rejection. An enhancer molecule is embedded in the basic construct of TruUCAR to enhance proliferation of TruUCAR T cells.
"We are very excited to present our data on GC502 at this year's AACR annual meeting. CD19 is a validated target in the treatment of r/r B-ALL," said Dr.
Between
As highlighted in the AACR poster, three out of four patients achieved minimal residual disease negative complete response or complete response with incomplete count recovery (MRD- CR/CRi), and one patient achieved a partial response at month one and subsequently received allogeneic hematopoietic stem-cell transplantation (allo-HSCT) on day 39.
Cytokine release syndrome (CRS) presented as Grade 2 and Grade 3 with no Grade 4 or 5 events. No immune effector cell-associated neurotoxicity syndrome (ICANS) or acute graft-versus-host disease (aGvHD) were observed.
For more information on the ongoing trial, refer to the ClinicalTrials.gov Identifier: NCT05105867.
Details of the presentation are as follows:
- Presentation Title: Early results of a safety and efficacy study of allogeneic TruUCAR GC502 in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
- Session Title: Phase I Clinical Trials 2
- Session Date and Time:
Tuesday, April 12 , from9:00AM –12:30PM CT - Location:
New Orleans Convention Center , Exhibit Halls D-H, Poster Section 33 - Poster Board Number: 21
- Permanent Abstract Number: CT196
Additional meeting information is available on the AACR website. The full text of the abstract is available on the AACR Online Itinerary Planner and the e-poster is viewable to registered attendees on the AACR's e-poster website through
About GC502
GC502 is a TruUCAR-enabled CD19/CD7 dual-directed, off-the-shelf allogeneic CAR-T product candidate that is being studied in an ongoing Phase 1 IIT in
About B-ALL
Acute lymphoblastic leukemia (ALL) is a type of blood cancer characterized by proliferation of immature lymphocytes in the bone marrow, which can involve either T lymphocytes (T-ALL), or B lymphocytes (B-ALL). Globally, approximately 64,000 patients are diagnosed with ALL every year with an estimated 6,660 new cases to be diagnosed in
About TruUCAR
TruUCAR is Gracell's proprietary technology platform and is designed to generate high-quality allogeneic CAR-T cell therapies that can be administered "off-the-shelf" at lower cost and with greater convenience. With differentiated design enabled by gene editing, TruUCAR is designed to control host versus graft rejection (HvG) as well as graft versus host disease (GvHD) without the need for being co-administered with additional immunosuppressive drugs after standard lymphodepletion. The novel dual-CAR design allows tumor antigen-CAR moiety to target malignant cells, while the CD7 CAR moiety is designed to suppress HvG response.
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 and SMART CART™ technology modules, 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. For more information on Gracell, please visit www.gracellbio.com. Follow @GracellBio on LinkedIn.
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