250 Participants Needed

CCS1477 for Blood Cancers

Recruiting at 20 trial locations
KC
TK
TK
KC
Overseen ByKaren Clegg, MD, MFPM
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 (inobrodib) in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop some medications. You must stop taking any chemotherapy, investigational agents, or other anti-cancer drugs at least 14 days before the trial. You also need to stop strong inhibitors or inducers of CYP3A4, statins, and CYP2C8 substrates within 2-4 weeks before starting the trial.

What safety data exists for CCS1477 (Inobrodib) in blood cancers?

The provided research does not contain specific safety data for CCS1477 (Inobrodib) in blood cancers. The articles focus on immune checkpoint inhibitors and their associated hematological toxicities, but do not mention CCS1477 or Inobrodib. Further research specific to CCS1477 is needed to determine its safety profile in blood cancer clinical trials.12345

Is the drug CCS1477 a promising treatment for blood cancers?

The information provided does not directly mention CCS1477 or its effects on blood cancers, so we cannot determine if it is a promising treatment based on this data.678910

What data supports the idea that CCS1477 for Blood Cancers is an effective treatment?

The available research does not provide specific data on the effectiveness of CCS1477 for Blood Cancers. Instead, it focuses on other treatments for chronic myeloid leukemia, such as tyrosine kinase inhibitors (TKIs) like imatinib, dasatinib, bosutinib, and nilotinib. These studies highlight the challenges of resistance and side effects associated with these drugs, but do not mention CCS1477. Therefore, there is no direct evidence from the provided information to support the effectiveness of CCS1477 for Blood Cancers.1112131415

Who Is on the Research Team?

TS

Tim Somervaille

Principal Investigator

The Christie NHS Foundation Trust

Are You a Good Fit for This Trial?

This trial is for adults with certain blood cancers like Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome who have relapsed after standard treatments. They must be relatively active (ECOG 0-2), have good organ function and not have taken other cancer drugs recently. People with severe diseases, recent major surgeries or those on specific drugs that affect the body's drug processing enzymes are excluded.

Inclusion Criteria

I can take care of myself and perform daily activities.
I have undergone standard treatment for my condition.
Provision of consent
See 2 more

Exclusion Criteria

I will stop taking statins before starting the study treatment.
I haven't taken any sensitive CYP2C8 drugs in the last 2 weeks.
I haven't taken any cancer drugs or experimental treatments in the last 14 days.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CCS1477 as monotherapy or in combination with other drugs for dose escalation and expansion

35 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • CCS1477
Trial Overview The study is testing CCS1477 alone or in combination with other drugs like Pomalidomide, Azacitidine, Dexamethasone, and Venetoclax to see how safe they are and how well they work against different blood cancers. It's an early-stage trial (Phase 1/2a) which means it's partly about finding the right dose as well as checking for any signs of effectiveness.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: CCS1477 monotherapy expansion and combination dose finding and expansion - MMExperimental Treatment3 Interventions
Group II: CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDSExperimental Treatment3 Interventions
Group III: CCS1477 monotherapy expansion and combination dose finding and expansion - AMLExperimental Treatment3 Interventions
Group IV: CCS1477 expansion phase NHL/Peripheral T-cell lymphomaExperimental Treatment1 Intervention
Group V: CCS1477 dose escalation NHL/MMExperimental Treatment1 Intervention
Group VI: CCS1477 dose escalation AML/Higher risk MDSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

CellCentric Ltd.

Lead Sponsor

Trials
3
Recruited
620+

Published Research Related to This Trial

In a study of 79 patients with chronic myeloid leukaemia, early increases in ABCB1 mRNA expression during imatinib therapy were found to predict poor treatment responses, indicating a potential for resistance to therapy.
Patients with a significant rise in ABCB1 mRNA (≥2.2 fold) were less likely to achieve early and major molecular responses, and this trend continued even when switched to nilotinib, suggesting that monitoring ABCB1 levels could help identify those needing alternative treatments.
The clinical significance of ABCB1 overexpression in predicting outcome of CML patients undergoing first-line imatinib treatment.Eadie, LN., Dang, P., Saunders, VA., et al.[2022]
A meta-analysis of 70 studies found that dasatinib is associated with the highest prevalence of hematological adverse events (AEs) in chronic myeloid leukemia (CML) patients, particularly anemia (54.5%), neutropenia (51.2%), and thrombocytopenia (62.2%).
Compared to imatinib, dasatinib significantly increases the odds of developing anemia (OR = 1.65), neutropenia (OR = 1.72), and thrombocytopenia (OR = 2.04), while nilotinib shows a lower risk for these AEs, indicating varying safety profiles among different TKIs.
Hematological Adverse Events with Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia: A Systematic Review with Meta-Analysis.Kronick, O., Chen, X., Mehra, N., et al.[2023]
Dendritic cells (DC) can be effectively generated from the blood of chronic myeloid leukemia (CML) patients, especially those treated with tyrosine kinase inhibitors (TKI), indicating a potential for DC immunotherapy in patients who do not achieve complete remission.
Patients treated with TKI showed a higher yield of mature DC and differences in immune cell populations, such as increased T regulatory and Th17 cells, suggesting these cells may play a role in the immune response against CML and warrant further investigation for enhancing immunotherapy outcomes.
Evaluation of monocyte-derived dendritic cells, T regulatory and Th17 cells in chronic myeloid leukemia patients treated with tyrosine kinase inhibitors.Hus, I., Tabarkiewicz, J., Lewandowska, M., et al.[2019]

Citations

The clinical significance of ABCB1 overexpression in predicting outcome of CML patients undergoing first-line imatinib treatment. [2022]
Hematological Adverse Events with Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia: A Systematic Review with Meta-Analysis. [2023]
Evaluation of monocyte-derived dendritic cells, T regulatory and Th17 cells in chronic myeloid leukemia patients treated with tyrosine kinase inhibitors. [2019]
Expression of the CTLA-4 ligand CD86 on plasmacytoid dendritic cells (pDC) predicts risk of disease recurrence after treatment discontinuation in CML. [2020]
NKG2D gene polymorphisms are associated with disease control of chronic myeloid leukemia by dasatinib. [2018]
Spectrum of Immune Checkpoint Inhibitor Anemias: Results From a Single Center, Early-Phase Clinical Trials Case Series Experience. [2022]
Current challenges of hematologic complications due to immune checkpoint blockade: a comprehensive review. [2022]
The risks of hematological toxicities of nivolumab in cancer patients: A PRISMA-compliant meta-analysis. [2023]
Management of immune checkpoint blockade dysimmune toxicities: a collaborative position paper. [2022]
Toxicity of Immune-Checkpoint Inhibitors in Hematological Malignancies. [2021]
ST1571, a tyrosine kinase inhibitor for the treatment of chronic myelogenous leukemia: validating the promise of molecularly targeted therapy. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Pharmacological and genomic profiling identifies NF-κB-targeted treatment strategies for mantle cell lymphoma. [2023]
Tyrosine kinase inhibitors in the treatment of chronic myeloid leukaemia: so far so good? [2015]
Olverembatinib: First Approval. [2022]
15.United Statespubmed.ncbi.nlm.nih.gov
Status of bcr-abl tyrosine kinase inhibitors in chronic myelogenous leukemia. [2019]
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