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DRUG CLASS:

CD19 inhibitor

1d
Study of JANX011 in Healthy Adult Volunteers to Assess Safety and Tolerability. (clinicaltrials.gov)
P1, N=60, Recruiting, Janux Therapeutics | Not yet recruiting --> Recruiting
Enrollment open • First-in-human
2d
Efficacy and Safety of Inebilizumab in the Treatment of Relapsing Neuromyelitis Optica Spectrum Disorder : A Multicenter, Randomized Controlled, Open-Label Study (ChiCTR2600119728)
P4, N=80, Completed, Affiliated Provincial Hospital of Shandong First Medical University (Shandong Provincial Hospital); Affiliated Provincial Hospital of Shandong First M
New P4 trial
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Uplizna (inebilizumab-cdon)
3d
Retrospective data • Journal
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ABL1 (ABL proto-oncogene 1)
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dasatinib • Blincyto (blinatumomab)
3d
Trial suspension
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cyclophosphamide • NKX019
4d
A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P1/2, N=26, Not yet recruiting, Memorial Sloan Kettering Cancer Center | Phase classification: P2 --> P1/2 | Initiation date: Mar 2026 --> Jun 2026
Phase classification • Trial initiation date
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
6d
CAR-NK Cells in B-cell Lymphoma: A New Frontier toward Accessible and Scalable Cellular Therapy. (PubMed, Blood Cancer Discov)
In this phase II study, TAK-007, an off-the-shelf allogeneic CD19 CAR NK-cell therapy expressing IL-15, demonstrates encouraging response rates, rapid treatment availability, and an excellent safety profile in heavily pretreated B-cell lymphoma, including post-CAR-T patients, albeit with limited durability. These findings, supported by integrated translational analyses, provide important mechanistic insights into CAR-NK biology that may guide future optimization and bring this approach closer to broader clinical application. See related article by Darrah et al., p. XX .
Journal
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IL15 (Interleukin 15)
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TAK-007
9d
Trial initiation date
11d
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
P1, N=18, Recruiting, TCRx Therapeutics Co.Ltd | N=30 --> 18 | Initiation date: May 2025 --> Sep 2025 | Trial primary completion date: Jun 2028 --> Dec 2028
Enrollment change • Trial initiation date • Trial primary completion date
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CD19 positive
11d
Single Ascending Dose Study of HB2198 in Healthy Participants (clinicaltrials.gov)
P1, N=32, Recruiting, Hinge Bio | Not yet recruiting --> Recruiting
Enrollment open
11d
Soundtrack-E: A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies (clinicaltrials.gov)
P1/2, N=408, Recruiting, AstraZeneca | N=276 --> 408 | Trial completion date: Feb 2028 --> Jun 2029
Enrollment change • Trial completion date
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CD19 (CD19 Molecule)
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Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • Calquence (acalabrutinib) • vincristine • prednisone • surovatamig (AZD0486)
15d
New P1/2 trial
16d
Challenges of Hepatitis B Virus Reactivation and CD19 Testing Following Tafasitamab Plus Lenalidomide for Relapsed Diffuse Large B-Cell Lymphoma. (PubMed, J Med Cases)
CD19 expression may be diminished by exams using a tafasitamab-competitive-binding clone. This case highlights not only the concern of HBV reactivation, but also the diagnostic challenge due to CD19 epitope masking following tafasitamab therapy.
Journal • IO biomarker
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CD19 (CD19 Molecule)
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lenalidomide • Monjuvi (tafasitamab-cxix)