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

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

7 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment called 1A46 for adults with advanced blood cancers that haven't responded to other treatments. The treatment works by targeting proteins on cancer cells, helping the immune system destroy them.

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.

Research Team

Clinical Trial Management

Principal Investigator

Chimagen Biosciences, Ltd

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+