Hematology Today—April 6, 2026

This week’s Hematology update highlights regulatory momentum, advancing cell therapies, pivotal trial initiations, guideline updates, and continued focus on equity and access.

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🩸 Bristol Myers Squibb expands Standing in the Gaap [1] [US • 31 Mar 2026]

https://news.bms.com/news/details/2026/Bristol-Myers-Squibb-Evolves-and-Expands-Standing-in-the-Gaap-to-Advance-More-Equitable-Care-in-Multiple-Myeloma-as-Program-Marks-Ten-Years/default.aspx
Context: Standing in the Gaap began in 2016, initially focused on African Americans with multiple myeloma, and has reached more than 5,000 attendees through 50-plus educational programs [1].
Key point: Bristol Myers Squibb said it is broadening the program and launching a US survey of more than 1,000 people with multiple myeloma, caregivers, and clinicians to better map care gaps in underserved communities [1].
Implication: May expand screening, initiation, and follow-up at scale.

🧬 Caribou wins FDA RMAT for CB-011 in multiple myeloma [2] [US • 31 Mar 2026]

https://investor.cariboubio.com/news-releases/news-release-details/caribou-biosciences-announces-fda-granted-regenerative-0
Context: CB-011 is an allogeneic anti-BCMA CAR-T in the Phase 1 CaMMouflage trial for relapsed or refractory multiple myeloma; Caribou said dose expansion is ongoing in BCMA-naïve and BCMA-exposed cohorts [2].
Key point: Caribou Biosciences announced FDA RMAT designation for CB-011, citing previously disclosed early data including a 92% ORR and 75% at least CR rate in a 12-patient BCMA-naïve cohort at the recommended dose for expansion [2].
Implication: May influence prescriber choice and payer reviews pending full data.

💊 CellCentric starts pivotal DOMMINO-1 for inobrodib [3] [UK/US • 31 Mar 2026]

https://www.cellcentric.com/press-release/cellcentric-initiates-dommino-1-a-pivotal-phase-2-clinical-trial-of-inobrodib-in-combination-with-pomalidomide-and-dexamethasone-inopd-in-relapsed-or-refractory-multiple-myeloma/
Context: DOMMINO-1 is an open-label, single-arm Phase 2 study in about 100 adults in the UK and US who previously received a bispecific antibody and are refractory to pomalidomide [3].
Key point: CellCentric said the first patient was dosed in DOMMINO-1, a registration-supporting trial of inobrodib plus pomalidomide and dexamethasone, with overall response rate as the primary endpoint [3].
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 CERo advances CER-1236 in AML, with MDS and MF expansion planned [4] [US • 30 Mar 2026]

https://www.cero.bio/press-release?storyId=4648490001655926
Context: CER-1236 is in a first-in-human Phase 1/1b study in hematologic malignancies; CERo said the protocol was amended to add transfusion-dependent MDS, high-risk MDS, and post-JAK-inhibitor myelofibrosis [4].
Key point: CERo Therapeutics reported dosing the second patient in cohort 2, the fifth patient overall, with ongoing safety, PK, PD, and clinical activity monitoring [4].
Implication: May influence prescriber choice and payer reviews pending full data.

🌞 Soligenix publishes HyBryte versus Valchlor CTCL data [5] [US • 02 Apr 2026]

https://ir.soligenix.com/2026-04-02-Positive-Clinical-Results-from-HyBryte-TM-Comparative-Study-Evaluating-HyBryte-TM-Against-Valchlor-R-in-the-Treatment-of-Cutaneous-T-Cell-Lymphoma-Published-in-Oncology-and-Therapy
Context: In this 12-week comparative study, treatment success was defined as at least 50% improvement in cumulative mCAILS score; the sample was small [5].
Key point: Soligenix said HyBryte showed a more rapid and more robust response than Valchlor in early-stage CTCL, with 60% versus 20% meeting treatment success, though the company noted the study did not reach statistical significance because of small sample size [5].
Implication: May influence prescriber choice and payer reviews pending full data.

🔬 AvenCell doses first patient with AVC-203 in QUADvance [6] [US/EU • 02 Apr 2026]

https://avencell.com/avencell-therapeutics-announces-first-patient-dosed-in-phase-i-quadvance-study-with-avc-203-a-novel-allogeneic-cd19-cd20-dual-targeting-car-t-investigational-therapy-for-the-treatment-of-relapsed-ref/
Context: AVC-203 is a CRISPR-engineered allogeneic CAR-T designed to target CD19 and CD20, with a switchable RevCAR component for future target expansion [6].
Key point: AvenCell Therapeutics announced first-patient dosing in the Phase I QUADvance study of AVC-203 for relapsed or refractory B-cell malignancies [6].
Implication: Signals pipeline investment and modality expansion.

🧪 Beam publishes BEACON data for risto-cel in NEJM [7] [US • 01 Apr 2026]

https://investors.beamtx.com/news-releases/news-release-details/beam-therapeutics-announces-publication-beacon-phase-12-data
Context: Beam said the ongoing Phase 1/2 BEACON study included 31 treated patients with sickle cell disease and severe VOCs, with follow-up from 0.3 to 20.4 months as of 06 Aug 2025 [7].
Key point: Beam Therapeutics announced NEJM publication of interim risto-cel data showing no investigator-reported severe VOCs after engraftment, durable HbF above 60%, HbS below 40%, and a planned US BLA submission as early as year-end 2026 [7].
Implication: May influence prescriber choice and payer reviews pending full data.

🩺 Agios moves mitapivat toward possible accelerated approval in SCD [8] [US • 31 Mar 2026]

https://investor.agios.com/news-releases/news-release-details/agios-advances-mitapivat-toward-potential-us-accelerated
Context: Agios said RISE UP Phase 3 met the hemoglobin response primary endpoint, while the pain-crisis primary endpoint did not reach statistical significance [8].
Key point: Agios said it plans to file an sNDA for mitapivat in sickle cell disease in the coming months after a pre-sNDA FDA meeting, and has already submitted a proposed confirmatory trial for review [8].
Implication: May influence prescriber choice and payer reviews pending full data.

📘 ASH issues new aplastic anemia practice guidelines [9] [01 Apr 2026]

https://www.hematology.org/newsroom/press-releases/2026/ash-guidelines-on-severe-acquired-aplastic-anemia
Context: The guidelines, published in Blood Advances, include 33 recommendations and four good practice statements for children and adults with severe and very severe acquired aplastic anemia [9].
Key point: ASH published evidence-based guidance covering diagnosis, advanced testing, initial treatment selection, eltrombopag use with immunosuppression, and management after non-response or relapse [9].
Implication: Could inform practice and payer discussions, interpretation depends on study design and confounding control.

🩸 Roche launches cobas MPX-E blood donor screening assay [10] [EU • 30 Mar 2026]

https://www.roche.com/investors/updates/inv-update-2026-03-30
Context: Roche said the CE-marked assay runs on cobas x800 systems and reports HIV, HCV, HBV, and HEV results in one multiplex NAT workflow [10].
Key point: Roche launched cobas MPX-E in countries accepting the CE mark, positioning it as a 4-in-1 donor screening test intended to improve laboratory efficiency and add HEV screening without extra instrumentation [10].
Implication: Introduces competition that may affect pricing and formulary access.

Why it matters

Multiple myeloma remained the densest theme this week, spanning equity programs, allogeneic CAR-T, and a registration-supporting oral regimen [1][2][3].
Cell therapy momentum continued across myeloma, B-cell malignancies, AML, and sickle cell disease, with several companies emphasizing access, manufacturing speed, and off-the-shelf potential [2][4][6][7].
Sickle cell disease had two notable regulatory and clinical readouts, Beam with peer-reviewed BEACON data, and Agios with an accelerated approval path discussion for mitapivat [7][8].
Non-drug practice changes also stood out, including ASH guideline publication and Roche’s donor-screening assay launch, both of which could affect standard workflows in hematology and transfusion medicine [9][10].
Soligenix’s HyBryte update adds another signal in rare oncology dermatology, but the company’s own release flags the small sample size, so interpretation should stay cautious [5].

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FAQ

What changed for CB-011 at Caribou Biosciences?

Caribou said the FDA granted RMAT designation to CB-011 for relapsed or refractory multiple myeloma. The designation was based on early CaMMouflage data, including previously disclosed activity in a 12-patient BCMA-naïve cohort [2].

What is DOMMINO-1 testing for CellCentric’s inobrodib?

DOMMINO-1 is a pivotal Phase 2, single-arm study of inobrodib plus pomalidomide and dexamethasone in heavily pretreated relapsed or refractory multiple myeloma. The primary endpoint is overall response rate [3].

What did Beam report for risto-cel in sickle cell disease?

Beam said interim BEACON data published in NEJM showed no investigator-reported severe VOCs after engraftment, rapid engraftment, and durable shifts in hemoglobin markers in 31 treated patients. The company said a BLA could come as early as year-end 2026 [7].

Why is Agios talking about accelerated approval for mitapivat?

Agios said FDA discussions after its pre-sNDA meeting support a potential accelerated approval pathway in sickle cell disease, with a confirmatory trial proposal already submitted. The company plans an sNDA in the coming months [8].

What is new in the ASH aplastic anemia guidelines?

ASH said the recommendations cover diagnosis, advanced testing, age- and donor-based treatment choice, adding eltrombopag to immunosuppressive therapy, and earlier second-line planning after non-response or relapse [9].

What does Roche’s cobas MPX-E add to blood screening?

Roche said the CE-marked test combines HIV, HCV, HBV, and HEV screening in one assay on cobas x800 systems. The company positions it as a faster, more efficient workflow, especially for labs adding HEV screening [10].

Entities / Keywords

Bristol Myers Squibb, BMS, Standing in the Gaap, multiple myeloma, health equity, underserved communities
Caribou Biosciences, CB-011, CaMMouflage, allogeneic CAR-T, anti-BCMA, RMAT, relapsed or refractory multiple myeloma
CellCentric, inobrodib, DOMMINO-1, p300/CBP inhibitor, InoPd, pomalidomide, dexamethasone, RRMM
CERo Therapeutics, CER-1236, CERTAIN-T, AML, MDS, MF, CER-T
Soligenix, HyBryte, SGX301, Valchlor, CTCL, cutaneous T-cell lymphoma, mCAILS
AvenCell Therapeutics, AVC-203, QUADvance, allogeneic CAR-T, CD19, CD20, RevCAR, B-cell malignancies
Beam Therapeutics, risto-cel, BEAM-101, BEACON, base editing, sickle cell disease, VOCs
Agios, mitapivat, RISE UP, sickle cell disease, accelerated approval, sNDA
American Society of Hematology, ASH, severe acquired aplastic anemia, Blood Advances, eltrombopag
Roche Diagnostics, cobas MPX-E, donor screening, NAT, HIV, HCV, HBV, HEV, cobas x800