P1, N=18, Not yet recruiting, Zhejiang University | Trial completion date: Oct 2026 --> Oct 2027 | Initiation date: Jun 2024 --> Dec 2024 | Trial primary completion date: Jun 2026 --> Jun 2027
4 months ago
Trial completion date • Trial initiation date • Trial primary completion date
Patients received a median of 2 prior lines (range 2 - 3) of therapy including rituximab and anthracyclines. GC012F CAR-T cells were detected in the tumor biopsies, indicating the infiltration of CAR-T cells into the tumor lesions. Overall, based on the safety and efficacy results, CD19-BCMA dual targeting CAR-T product GC012F is a promising therapy for patients with refractory/ relapsed DLBCL.
Patients received a median of 2 prior lines (range 2 - 3) of therapy including rituximab and anthracyclines. This first-in-human trial of GC012F,a CD19-BCMA dual targeting CAR-T product, for thetreatment of r/r B-NHL showed a manageablesafety profileand promising clinical responses.The ORR was 100% at month 3 with 77.8% (7/9) achieving CR. GC012F CAR-Tcells were detectablein thetumor biopsies, indicating theinfiltration of CAR-T cells into thetumor lesions.Study with larger cohortand longer follow-up is ongoing. Keywords: CAR-T
The updated results showed GC012F continues to provide deep and durableresponses,and a very high MRD negativity ratein RRMM pts, including in pts refractory to anti-CD38, PIs and IMiDs. Given the promising results of thecurrent study, further clinical studies will beconducted to confirm theefficacy as well as safety of GC012F therapy for RRMM patients. Keywords: relapsed/refractory, CAR-T, Multiple myeloma
Pts received a median of 2 prior lines (range 2-3) of therapy including rituximab and anthracyclines. This first-in-human trial of GC012F for the treatment of r/r B-NHL showed a manageable safety profile and promising clinical responses. The ORR was 100% at M3 with 77.8% (7/9) achieving CR. GC012F CAR-T cells were detectable in the tumor biopsies, indicating the infiltration of CAR-T cells into the tumor lesions.
The updated results showed GC012F continues to provide deep and durable responses, and a very high MRD negativity ratein RRMM pts, including in pts refractory to anti-CD38, PIs and IMIDs. Based on these promising results of the study of GC012F for RRMM, further clinical studies will be conducted to confirm the efficacy of GC012F. Clinical trial information: NCT04236011; NCT04182581.
Twelve pts received 2 cycles induction therapy of bortezomib, lenalidomide and dexamethasone (VRd), and one patient received 1 cycle bortezomib, epirubicin, and dexamethasone (PAD) and 1 cycle VRd prior to the infusion. GC012F was administered as a single infusion at 3 doses levels (DL) of 1x105/kg, 2x105/kg, or 3x105/kg, after receiving a conditioning chemotherapy consisting of cyclophosphamide and fludarabine...Conclusion In this phase I study for transplant-eligible newly diagnosed high-risk MM, BCMA-CD19 dual FasTCAR-T GC012F showed a very favorable safety profile, high efficacy with 100% ORR and 100% MRD negativity. The promising preliminary results warrants further assessment of GC012F for TE NDMM with more patients and longer follow-up.
Conclusion BCMA-CD19 dual FasT CAR-T GC012F continues to provide deep and durable responses with a favorable safety profile in additional RRMM pts across all dose levels demonstrating a very high MRD negativity rate including in pts refractory to anti-CD38, PI and IMIDs. Based on these promising results GC012F is being studied in earlier lines of therapy as well as additional indications.
All three pts achieved CR by PET-CT at day 28 after GC012F infusion, and response is ongoing at 3-months follow-up in the two assessable patients. Conclusion The preliminary safety and tolerability of GC012F in r/r B-NHL at three different dose levels ranging from 3.7*10 4 CAR-T/kg-3*10 5 CAR-T/kg showed promising early and potent activity in r/r B-NHL pts with 100% CR rate at 1-month which was maintained in pts that were available to be assessed at the 3-month visit including r/r DLBCL pts and pts with bulky disease whose treatment is often challenging. Additional pts and longer follow up are needed to further evaluate these promising early results of GC012F in r/r B-NHL and to determine the RP2D for phase 2.
BCMA-CD19 dual FasT CAR-T GC012F continues to provide deep and durable responses with a favorable safety profile in additional RRMM pts across all dose levels demonstrating a very high MRD negativity rate including in pts refractory to anti-CD38, PI and IMIDs. GC012F is currently being studied in earlier lines of therapy as well as additional indications.
At data cut off, the median time to follow up was 13.8 mths (6.1-16.4) – with the median duration of response not yet reached. Cytokine Release Syndrome (CRS) and ICANs were graded by ASBMTcriteria: grade 1-2 n=16 (84.2%), grade 3 n=2 (10.5%). Median duration of CRS was 4d (1-8d). No grade 4/5 CRS or Immunce effector cell-associated Neurotoxicity syndrome (ICANS) were observed. 2 deaths occurred on study and were assessed as not related to therapy – one reported previously; one patient was diagnosed with& Conclusion BCMA-CD19 dual FasT CAR-T GC012F showed early, deep and durable responses with a high ORR (94.7%; VGPR or better) including a high MRD negative sCR rate (DL3=100%, n=9) in high risk RRMM pts including those refractory to anti-CD38, PI and IMIDs with a favorable safety profile consistent with previous findings. BCMA-CD19 dual FasT CAR-T GC012F may present a new treatment approach for patients with RRMM including those with high-risk features refractory to standard of care.
BCMA-CD19 dual FasT CAR-T GC012F showed early, deep and durable responses with a high ORR (94.7% - VGPR and better) including a high MRD- sCR rate (DL3=100%, n=9) in high risk RRMM pts including those refractory to anti-CD38, PI and IMIDs with a favorable safety profile consistent with previous findings . BCMA-CD19 dual FasT CAR-T GC012F may present a new treatment approach for patients with RRMM including those with high-risk features refractory to standard of care.