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DRUG:

AZD0120

i
Other names: GC-012F, AZD 0120, GC 012, GC 012F, AZD0120, GC012F, GC012, Dual CAR-BCMA-19, BCMA/CD19 dual-target CAR-T cell immunotherapy, AZD-0120, GC-012
Company:
AstraZeneca
Drug class:
CD19-targeted CAR-T immunotherapy, BCMA-targeted CAR-T immunotherapy
Related drugs:
7d
A Study of GC012F (AZD0120), a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
P1/2, N=80, Recruiting, AstraZeneca | Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Mar 2026 --> Dec 2026
Trial completion date • Trial primary completion date • CAR T-Cell Therapy
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AZD0120
10d
A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus (clinicaltrials.gov)
P1/2, N=118, Recruiting, Gracell Biotechnologies (Shanghai) Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open
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AZD0120
4ms
A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus (clinicaltrials.gov)
P1/2, N=118, Not yet recruiting, Gracell Biotechnologies (Shanghai) Co., Ltd.
New P1/2 trial
|
AZD0120
4ms
An Exploratory Clinical Study of GC012F Injection for Refractory gMG (clinicaltrials.gov)
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
Trial completion date • Trial initiation date • Trial primary completion date
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AZD0120
5ms
A Study of GC012F, a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
P1/2, N=71, Recruiting, Gracell Biopharmaceuticals, Inc. | Phase classification: P1b/2 --> P1/2
Phase classification • CAR T-Cell Therapy
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AZD0120
9ms
Study of FasT CAR-T GC012F Injection NDMM Patients (clinicaltrials.gov)
P1, N=18, Recruiting, Shanghai Changzheng Hospital | Not yet recruiting --> Recruiting
Enrollment open
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AZD0120
10ms
New P1/2 trial
|
AZD0120
12ms
CD19/BCMA Dual-Targeting Fastcar-T GC012F for Patients with Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma: An Update (ASH 2023)
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.
Clinical
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CD19 (CD19 Molecule)
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CD19 expression
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Rituxan (rituximab) • AZD0120
over1year
UPDATED CLINICAL RESULTS OF FIRST-IN-HUMAN STUDY OF CD19/BCMA DUAL-TARGETING FAST CAR-T GC012F FOR PATIENTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN’S LYMPHOMA (EHA 2023)
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
Clinical • P1 data
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CD19 (CD19 Molecule)
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CD19 expression • CD19 expression + TNFRSF17 expression
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Rituxan (rituximab) • AZD0120
over1year
UPDATED RESULTS OF A PHASE I, OPEN-LABEL STUDY OF BCMA/CD19 DUAL-TARGETING FASTCAR-T GC012F FOR PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) (EHA 2023)
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
Clinical
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AZD0120
over1year
Updated clinical results of first-in-human study of CD19/BCMA dual-targeting fast CAR-T GC012F for patients with relapsed/refractory B-cell non-Hodgkin’s lymphoma. (ASCO 2023)
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.
Clinical • P1 data
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CD19 (CD19 Molecule)
|
CD19 expression • CD19 expression + TNFRSF17 expression
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Rituxan (rituximab) • AZD0120
over1year
Updated results of a phase I, open-label study of BCMA/CD19 dual-targeting fast CAR-T GC012F for patients with relapsed/refractory multiple myeloma (RRMM). (ASCO 2023)
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.
Clinical
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AZD0120
2years
Phase I Open-Label Single-Arm Study of BCMA/CD19 Dual-Targeting FasTCAR-T Cells (GC012F) As First-Line Therapy for Transplant-Eligible Newly Diagnosed High-Risk Multiple Myeloma (ASH 2022)
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.
Clinical • P1 data • CAR T-Cell Therapy
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CD19 (CD19 Molecule)
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lenalidomide • bortezomib • cyclophosphamide • epirubicin • dexamethasone • fludarabine IV • AZD0120
over2years
UPDATED RESULTS OF A MULTICENTER FIRST-IN-HUMAN STUDY OF BCMA/CD19 DUAL-TARGETING FAST CAR-T GC012F FOR PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) (EHA 2022)
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.
Clinical • P1 data
|
CD19 (CD19 Molecule)
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AZD0120
over2years
FIRST-IN-HUMAN STUDY OF CD19/BCMA DUAL-TARGETING FAST CAR-T GC012F FOR PATIENTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN'S LYMPHOMA (EHA 2022)
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.
Clinical • P1 data • IO biomarker
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MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • CD19 (CD19 Molecule)
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BCL2 expression • MYC expression
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AZD0120
over2years
Updated results of a multicenter first-in-human study of BCMA/CD19 dual-targeting fast CAR-T GC012F for patients with relapsed/refractory multiple myeloma (RRMM). (ASCO 2022)
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.
Clinical • P1 data
|
CD19 (CD19 Molecule)
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AZD0120
almost3years
GC012F-32: Study of FasT CAR-T GC012F Injection in High Risk TE NDMM Patients (clinicaltrials.gov)
P1/2, N=20, Recruiting, Shanghai Changzheng Hospital | Not yet recruiting --> Recruiting
Clinical • Enrollment open
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IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10)
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AZD0120
over3years
Study of FasT CAR-T GC012F Injection in High Risk TE NDMM Patients (clinicaltrials.gov)
P1/2, N=20, Not yet recruiting, Shanghai Changzheng Hospital
Clinical • New P1/2 trial
|
IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10)
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AZD0120
over3years
[VIRTUAL] LONG-TERM FOLLOW-UP RESULTS OF A MULTICENTER FIRST-IN-HUMAN STUDY OF THE DUAL BCMA/CD19 TARGETED FAST CAR-T GC012F FOR PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (EHA 2021)
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.
Clinical • P1 data
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CD19 (CD19 Molecule)
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AZD0120
over3years
[VIRTUAL] Long-term follow-up results of a multicenter first-in-human study of the dual BCMA/CD19 Targeted FasT CAR-T GC012F for patients with relapsed/refractory multiple myeloma. (ASCO 2021)
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.
Clinical • P1 data
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CD19 (CD19 Molecule)
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AZD0120