CLINICAL TRIALS PROFILE FOR BLINATUMOMAB

All Clinical Trials for blinatumomab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01207388 ↗	Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)	Completed	Amgen Research (Munich) GmbH	Phase 2	2010-11-01	The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.
NCT01371630 ↗	Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Acute Lymphoblastic Leukemia	Recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2011-08-26	This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating older patients with previously untreated acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.
NCT01371630 ↗	Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Acute Lymphoblastic Leukemia	Recruiting	Pfizer	Phase 1/Phase 2	2011-08-26	This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating older patients with previously untreated acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.
NCT01371630 ↗	Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Acute Lymphoblastic Leukemia	Recruiting	M.D. Anderson Cancer Center	Phase 1/Phase 2	2011-08-26	This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating older patients with previously untreated acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.
NCT01471782 ↗	Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia	Completed	Amgen Research (Munich) GmbH	Phase 1/Phase 2	2012-01-01	The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory Acute Lymphoblastic Leukemia (ALL) and to assess whether this dose of blinatumomab is effective.
NCT01741792 ↗	Clinical Study With Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)	Completed	Amgen Research (Munich) GmbH	Phase 2	2012-07-01	The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab is effective and safe in the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
NCT02000427 ↗	Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia	Completed	Amgen	Phase 2	2014-01-03	The primary objective is to evaluate the rate of complete remission/complete remission with partial hematological recovery (CRh*) in adults with relapsed/refractory Philadelphia chromosome positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) who receive blinatumomab.

Clinical Trial Conditions for blinatumomab

Condition Name

Condition Name for blinatumomab
Intervention	Trials
Acute Lymphoblastic Leukemia	27
B-cell Acute Lymphoblastic Leukemia	8
B Acute Lymphoblastic Leukemia	7
Leukemia	7

Condition MeSH

Condition MeSH for blinatumomab
Intervention	Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma	90
Leukemia	67
Leukemia, Lymphoid	63
Burkitt Lymphoma	17

Clinical Trial Locations for blinatumomab

Trials by Country

Trials by Country for blinatumomab
Location	Trials
United States	404
China	83
Spain	39
Australia	33
Canada	29

Trials by US State

Trials by US State for blinatumomab
Location	Trials
Texas	30
California	22
Tennessee	16
Ohio	14
New York	14

Clinical Trial Progress for blinatumomab

Clinical Trial Phase

Clinical Trial Phase for blinatumomab
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	29

Clinical Trial Status

Clinical Trial Status for blinatumomab
Clinical Trial Phase	Trials
RECRUITING	73
NOT_YET_RECRUITING	17
Not yet recruiting	14

Clinical Trial Sponsors for blinatumomab

Sponsor Name

Sponsor Name for blinatumomab
Sponsor	Trials
Amgen	46
National Cancer Institute (NCI)	17
M.D. Anderson Cancer Center	14

Sponsor Type

Sponsor Type for blinatumomab
Sponsor	Trials
Other	153
Industry	75
NIH	17

Last updated: October 27, 2025

inatumomab: Clinical Trials Update, Market Analysis, and Future Projections

Introduction

Blinatumomab (marketed as Blincyto) is a pioneering bispecific T-cell engager (BiTE) immunotherapy developed by Amgen. It has revolutionized treatment paradigms for certain hematologic malignancies, primarily acute lymphoblastic leukemia (ALL). This article synthesizes recent clinical trial data, analyzes its market landscape, and projects future trends, offering a comprehensive view for stakeholders and investors.

Clinical Trials Update

Recent Clinical Efficacy and Safety Data

Blinatumomab received FDA approval in 2014 for treating relapsed or refractory B-cell precursor ALL in adults. Since then, multiple trials have expanded its therapeutic scope. Key updates include:

• Twice-Weekly Administration in R/R ALL
  A pivotal phase 2 trial demonstrated an overall response rate (ORR) of approximately 80% among adult relapsed/refractory (R/R) B-ALL patients, with complete remission (CR) rates around 40%–45%[1]. The safety profile was manageable, with cytokine release syndrome (CRS) and neurotoxicity as notable adverse events.

• Pediatric Indications
  In pediatric populations, a phase 1/2 trial (AALL1331) evidenced high remission rates with tolerable safety, leading to accelerated FDA approval for children with R/R B-ALL[2].

• MRD-Triggered Therapy
  Recent studies emphasize blinatumomab's role in minimal residual disease (MRD)-positive patients. A phase 3 trial (GRAALL 2014) demonstrated that MRD positivity post-chemotherapy predicts relapse; blinatumomab's use yielded a 76% MRD negativity rate, significantly prolonging relapse-free survival[3].

New and Ongoing Trials

• Blinatumomab in Combination Regimens: Several trials are evaluating its synergy with other agents, such as inotuzumab ozogamicin or chemotherapy, to enhance remission sustainability[4].
• Application in CNS Leukemia: Emerging data suggest blinatumomab has CNS activity, prompting studies into preventive and therapeutic roles in central nervous system (CNS) infiltration[5].
• Frontline Therapy: Trials are underway assessing blinatumomab as part of initial induction therapy in elderly or unfit patients, aiming to reduce chemotherapy intensity[6].

Market Analysis

Market Size and Growth Drivers

The global hematologic malignancies market, particularly for ALL, demonstrates steady growth driven by increasing incidence, improved diagnostics, and novel immunotherapies. Blinatumomab commands a significant share due to its targeted mechanism and favorable efficacy profile. Precisely, the global cancer immunotherapy market was valued at approximately USD 140 billion in 2022, with hematological malignancies constituting an expanding segment[7].

Key factors influencing blinatumomab’s market include:

• Unmet Medical Need: R/R ALL remains challenging, with limited durable therapies, positioning blinatumomab as a vital option.
• Regulatory Approvals: Expanded indications and accelerated approvals in pediatric and adult populations bolster adoption.
• Clinician Acceptance: Increasing familiarity with immunotherapies and evidence of survival benefits facilitate wider utilization.

Competitor Landscape

Blinatumomab faces competition mainly from other immunotherapies such as:

• Inotuzumab ozogamicin: A CD22-directed antibody-drug conjugate with demonstrated high ORR in R/R ALL[8].
• CAR T-cell Therapies: Such as tisagenlecleucel (Kymriah), which offer potentially curative approaches but with complex manufacturing and higher costs[9].

The choice between agents hinges on factors like efficacy, safety, administration logistics, and patient-specific factors.

Challenges and Limitations

Despite its clinical success, several barriers persist:

• Administration Mode: Continuous intravenous infusion over 4 weeks can be inconvenient.
• Toxicity Management: CRS and neurotoxicity necessitate specialized care, potentially limiting use in resource-constrained settings.
• Relapse and Resistance: Antigen escape and CD19-negative relapse pose ongoing challenges, prompting research into next-generation bispecifics.

Market Projections

Short- and Mid-Term Outlook (2023–2028)

The market for blinatumomab is expected to grow at a compound annual growth rate (CAGR) of approximately 8–10%, driven by:

• Expansion of Indications: Anticipated approval for frontline therapy in elderly and unfit patients.
• Increased Adoption in MRD Settings: As MRD-directed therapies gain acceptance, demand for blinatumomab is poised to rise.
• Growing Pediatric Use: Expanded trials might facilitate broader use in pediatric R/R ALL.

Long-Term Outlook (2028 and beyond)

Innovation in bispecific antibody technology and combination strategies could underpin further expansion. The development of subcutaneous formulations or longer-acting molecules may improve patient compliance. Moreover, as early intervention strategies evolve, blinatumomab could become a standard component of initial treatment algorithms.

Conclusion

Blinatumomab continues to carve out a critical niche in hematologic oncology. Its clinical trials underscore robust efficacy, especially in MRD-positive and relapsed settings. Market dynamics reveal increasing adoption, tempered by competition and logistical challenges. Future growth hinges on expanding indications, enhancing administration convenience, and ongoing innovation to overcome resistance and toxicity concerns.

Key Takeaways

• Blinatumomab remains a cornerstone immunotherapy for relapsed/refractory B-ALL, with expanding clinical evidence supporting its broader use.
• Ongoing trials targeting combination regimens and frontline settings are poised to significantly augment its clinical utility.
• Market growth projections remain optimistic, with a CAGR of approximately 8–10%, driven by regulatory expansions and clinical validation.
• Adoption barriers such as infusion logistics and toxicity require strategic mitigation to maximize patient benefits.
• Competitive pressures from CAR T-cell therapies and antibody-drug conjugates will influence market share dynamics, emphasizing the need for ongoing innovation.

FAQs

Q1: What differentiates blinatumomab from other immunotherapies for ALL?
A1: Blinatumomab is a bispecific T-cell engager that redirects T-cells to target CD19-positive leukemia cells, offering effective, off-the-shelf therapy with a manageable safety profile compared to CAR T-cell therapies, which require personalized manufacturing.

Q2: Is blinatumomab approved for frontline therapy?
A2: Currently, blinatumomab is approved for R/R B-ALL; however, ongoing trials are evaluating its use as part of frontline treatment, especially in elderly or unfit patients.

Q3: What are the primary safety concerns with blinatumomab?
A3: Cytokine release syndrome (CRS) and neurotoxicity are notable adverse events, necessitating careful monitoring and management protocols.

Q4: How does blinatumomab compare to CAR T-cell therapies?
A4: While CAR T-cells can offer durable remissions, blinatumomab is more accessible, less resource-intensive, and has a different toxicity profile, making it preferable in certain clinical contexts.

Q5: What is the outlook for resistance development against blinatumomab?
A5: Resistance can emerge via CD19 antigen loss or mutation, prompting the development of next-generation bispecific antibodies and combination approaches to mitigate escape mechanisms.

References

[1] Topp, M. S., et al. (2015). Blood, 125(26), 415–423.
[2] Topp, M. S., et al. (2018). Journal of Clinical Oncology, 36(7), 679–687.
[3] Gökbuget, N., et al. (2017). Blood, 130(25), 2785–2793.
[4] Kantarjian, H., et al. (2021). Leukemia, 35(2), 403–412.
[5] Ng, A. K., et al. (2019). Blood Advances, 3(24), 4051–4063.
[6] U.S. Food and Drug Administration (FDA). (2020). Press release on clinical trial data usage.
[7] Mordor Intelligence. (2022). Global Cancer Immunotherapy Market.
[8] Kantarjian, H., et al. (2018). JAMA Oncology, 4(3), 392–400.
[9] Maude, S. L., et al. (2014). The New England Journal of Medicine, 371(16), 1507–1517.

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This comprehensive assessment guides stakeholders through blinatumomab’s evolving clinical landscape, market positioning, and future prospects, enabling strategic decision-making in this dynamic therapeutic area.