1A46 Injection for Non-Hodgkin's Lymphoma and Acute Lymphoblastic Leukemia

No longer recruiting at 4 trial locations

Overseen By Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Chimagen Biosciences, Ltd

Must not be taking: Corticosteroids, Immunosuppressive

Disqualifiers: Brain metastasis, Active infection, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new injection called 1A46 to determine its safety and effectiveness for certain advanced blood cancers. It focuses on treating non-Hodgkin's lymphoma (NHL) and acute lymphoblastic leukemia (ALL), specifically targeting cells with CD20 or CD19 markers. Candidates for this trial have NHL or ALL that did not respond well to other treatments and need new options. This trial could be an option to consider for those in this situation. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take certain medications like high-dose corticosteroids or immunosuppressive drugs shortly before starting the trial. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that 1A46 Injection is likely to be safe for humans?

In a previous study, researchers tested the 1A46 injection on patients with advanced blood cancers, such as certain types of non-Hodgkin's lymphoma and leukemia. This study marked one of the first human trials of 1A46, focusing primarily on its safety.

As an early trial, researchers continue to carefully examine the treatment's safety. The trial's phase suggests that 1A46 showed promise in being well-tolerated during initial tests. Although the treatment is new, it has passed early safety checks to reach this stage of testing.

Researchers are closely monitoring 1A46 for side effects and patient tolerance. More detailed results will become available as the trial progresses and more participants receive the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Non-Hodgkin's Lymphoma and Acute Lymphoblastic Leukemia, which often include chemotherapy and targeted therapies like rituximab, 1A46 Injection is unique because it introduces a new mechanism of action by directly targeting cancer cells. Researchers are excited about 1A46 because it may offer a more precise approach, potentially leading to fewer side effects and greater effectiveness. This novel injection might transform the way these cancers are treated, providing hope for patients who have not responded well to existing therapies.

What evidence suggests that 1A46 Injection might be an effective treatment for non-Hodgkin's lymphoma and acute lymphoblastic leukemia?

Research has shown that the 1A46 Injection targets specific proteins called CD20 and CD19, found on some cancer cells. These proteins often appear in cancers such as non-Hodgkin's lymphoma (NHL) and acute lymphoblastic leukemia (ALL). The 1A46 Injection aims to help the immune system locate and destroy these cancer cells. Early studies suggest that treatments targeting these proteins have shown promise in shrinking tumors or slowing the disease. Although data on 1A46 remains limited, its method is based on strategies that have succeeded in similar conditions. ^{1 2 4 6 7}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Chimagen Biosciences, Ltd

Are You a Good Fit for This Trial?

Adults with advanced B-cell non-Hodgkin's lymphoma or acute lymphoblastic leukemia that have tried at least two other treatments and can't undergo or haven't benefited from stem cell transplant. They must not be using high-dose steroids, have active hepatitis, recent heart issues, major surgery, uncontrolled diseases, severe allergies to monoclonal antibodies, COVID-19 infection, another cancer within the last 5 years (with some exceptions), certain heart conditions or neurological issues.

Inclusion Criteria

ALL Patients meeting specified criteria

I need treatment for my non-Hodgkin lymphoma.

I have NHL and meet the specific treatment history requirements.

Exclusion Criteria

I do not have an active hepatitis B or C infection.

Illicit drug use, drug abuse, or alcohol abuse

I haven't taken steroids or immunosuppressants recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of 1A46 to determine the maximum tolerated dose

28 days per cycle

Multiple visits per cycle

Dose Expansion

Participants receive the recommended phase 2 dose to further evaluate safety and efficacy

Up to 1 year

Regular visits throughout the treatment period

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• 1A46 Injection

Trial Overview The trial is testing a new injection called 1A46 for its safety and effectiveness in treating adults with specific types of blood cancers that express CD20 and/or CD19 proteins. The study will include patients who have already undergone multiple previous therapies without success.

How Is the Trial Designed?

Group I: Dose Escalation Experimental Treatment 1 Intervention

Open label, single arm trial where 1A46 will be administered

Who Is Running the Clinical Trial?

Chimagen Biosciences, Ltd

Lead Sponsor

Trials

1

Recruited

7+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05348889

NCT05348889 | First-in-Human (FIH) Trial of 1A46 ... This study will evaluate the safety and efficacy of 1A46 in adult patients with advanced CD20 and/or CD19 positive B-cell non-Hodgkin's lymphoma (NHL) or acute ...

2. withpower.com withpower.com/trial/phase-2-non-hodgkins-lymphoma-disorder-3-2022-aedd0

1A46 Injection for Non-Hodgkin's Lymphoma and Acute ... This trial tests a new treatment called 1A46 for adults with advanced blood cancers that haven't responded to other treatments.

3. synapse.patsnap.com synapse.patsnap.com/drug/168cabc430e8434d80ef7e514302e93e

CMG1A46 - Drug Targets, Indications, Patents A Phase I/II, open-label, first-in-human, single-arm study evaluating the safety and efficacy of a trispecific T-cell mediator antibody (1A46) in adult ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11866492/

CD70-targeted iPSC-derived CAR-NK cells display potent ... CD70-targeted therapies, including antibody-drug conjugates, antibodies, and CAR-T cells, have shown promising efficacy in treating acute ...

5. sigma.larvol.com sigma.larvol.com/facility.php?e1=586&e2=&FacilityId=586&tab=FacilityOTT&sr=now&er=1+month&itype=0,1&ipwnd=on&rlink=,FacilityId=586,itype=0,1&rflag=1&page=6

University of Maryland Trials ... efficacy outcomes data for ... 1/2. 7. US. 1A46 Injection, CMG1A46. Chimagen Biosciences, Ltd. Non ... Non-Hodgkin Lymphoma, B-cell Acute Lymphoblastic Leukemia.

6. ctv.veeva.com ctv.veeva.com/study/first-in-human-fih-trial-of-1a46-in-subjects-with-advanced-cd20-and-or-cd19-positive-b-cell-hemato

First-in-Human (FIH) Trial of 1A46 in Subjects with Advanced ... This study will evaluate the safety and efficacy of 1A46 in adult patients with advanced CD20 and/or CD19 positive B-cell non-Hodgkin's lymphoma (NHL) or acute ...

7. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/non-hodgkin-lymphoma

Non-Hodgkin Lymphoma clinical trials at UCSF This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab or glofitamab in combination with CELMoDs (CC-220 and/or CC ...