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Non-Hodgkin's Lymphoma (disorder)Phase 1/2NCT05348889

First-in-Human (FIH) Trial of 1A46 in Subjects with Advanced CD20 And/or CD19 Positive B-cell Hematologic Malignancies

A Phase 1/2 study testing 1A46 Injection in people with Non-Hodgkin's Lymphoma (disorder) and Acute Lymphoid Leukemia, Disease (disorder), run by Chimagen Biosciences, Ltd at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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 lymphoblastic leukemia (ALL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
1A46 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
5 sitesUnited States
Study dates
30 Aug 2022to 31 Oct 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Dose Escalation Part:
  • Aggressive NHL Patients：
  • Aggressive NHL including mantle cell lymphoma and DLBCL histologies, NOS and/or BCL2, BCL6, and or MY B-cell lymphoma with intermediate features between DLBCL, FL grade 3B, and aggressive B-cell lymphoma unclassifiable
  • have previously R-CHOP, R-EPOCH or equivalent anti-CD20 containing therapy
  • with ≥ 2 prior lines of systemic therapy
  • received or ineligible for autologous stem cell transplant (ASCT)
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  • have received or been intolerant of all other standard therapies thought to confer clinical benefit.
  • Indolent NHL Patients:
  • including FL of Grades 1-3A and marginal zone lymphoma (MZL)
  • refractory or relapsed after ≥ 2 prior lines of systemic therapy who have received or been intolerant of all other standard therapies thought to confer clinical benefit.
  • Patients must require systemic therapy based on disease-specific criteria.
  • NHL patients should meet the following requirements:
  • The following considerations pertain to prior treatment regimens for NHL:
  • Preinduction salvage chemotherapy and ASCT should be considered 1 therapy.
  • Patients with gastric extranodal MZL, should have failed H. pylori eradication therapy (when H. pylori positive).
  • NHL patients must have expression of CD20 and/or CD19-expression
  • NHL patients in the dose escalation part of the study must have ≥ 1 measurable target lesion as defined by Lugano 2014 criteria ALL Patients：
  • Ph-positive or Ph-negative B-cell ALL refractory to or relapsed after frontline treatment and 1 salvage regimen, have received or been intolerant of all other standard therapies thought to confer clinical benefit. ALL patients should meet the following requirements:
  • Relapsed after or not a candidate for allogeneic SCT.
  • No active acute or chronic graft-versus-host disease for 2 months prior to enrollment and currently receiving no immunosuppressive therapy.
  • persistent CD19 staining of ≥ 50% of blasts.

Who cannot join

  • Patient has brain metastasis or other significant neurological conditions.
  • Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period.
  • Active serious infection requiring antibiotics within 14 days before study entry.
  • Treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or immunosuppressive medication ≤ 7 days before the first dose of 1A46, with the following exceptions:
  • Topical, ocular, intra-articular, intranasal, or inhalational corticosteroids.
  • Dexamethasone used to reduce peripheral blast counts in ALL patients.
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  • Active hepatitis B or C.
  • Known human immunodeficiency virus (HIV) infection.
  • Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.
  • Cerebrovascular accident, transient ischemic attack, myocardial infarction, unstable angina, or New York Heart Association class III or IV heart failure < 6 months of study entry; uncontrolled arrhythmia < 3 months of study entry.
  • Major surgery < 4 weeks or minor surgery < 2 weeks prior to screening.
  • Live virus vaccines < 30 days prior to screening.
  • Inflammatory chronic diseases, or any other diseases the investigator considers can be exacerbated in the setting of immune activation.
  • History of Grade 3-4 allergic reaction to treatment with another mAb, or known to be allergic to protein drugs or recombinant proteins or excipients in 1A46 drug formulation.
  • Concurrent malignancy < 5 years prior to entry other than adequately treated cervical carcinoma in situ, localized squamous cell cancer of the skin, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or < T1 urothelial carcinoma.
  • History of Grade 3-4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies.
  • Pleural effusion, pericardial effusion or ascites requiring frequent drainage or medical intervention.
  • QTc > 480 msec using Fredericia's QT correction formula
  • Patients in the dose escalation part who weigh < 40 kg.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4000

  • Norton Cancer Institute

    Louisville, Kentucky, 40202-1840

  • Froedtert & the Medical College of Wisconsin Froedtert Hospital

    Milwaukee, Wisconsin, 53226-3522

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510-3220

  • UPMC CancerCenter

    Pittsburgh, Pennsylvania, 15232-1309

Other trials in United States

About this study

Official title: A Phase 1/2, First in Human, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Triple-specific T-cell Engager 1A46 in Adult Patients with Advanced CD20 And/or CD19 Positive B-cell Hematologic Malignancies

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 lymphoblastic leukemia (ALL).

Read the detailed description

This study is an open-label, multicenter, 2-part study of 1A46 in adult patients with advanced relapsed/refractory (r/r) CD20 and/or CD19 positive B-cell non-Hodgkin lymphoma (NHL) and B-cell acute lymphoblastic leukemia (ALL) who do not have effective standard treatment available. This FIH study will include a dose escalation part and a dose expansion part in 4 cohorts.

Being tested
1A46 Injection
Medical subject headings
Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1A46 InjectionDrug

    Also called CMG1A46

    Participants will receive IV 1A46 weekly for Cycles 1-8, then every 3 weeks (Q3W) for Cycles 9-16 (21 days/cycle).

Study groups in NCT05348889
Study groupRoleWhat they receive
Dose EscalationExperimentalOpen label, single arm trial where 1A46 will be administered
Receives: Drug: 1A46 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Escalation: Incidence of Adverse Events

    To assess the safety and tolerability of 1A46

    Measured: Adverse Events are assessed during the first cycle (28 days) in each cohort

  2. Escalation: Dose liming toxicity (DLT)

    To identify the RP2D and the MTD, if reached

    Measured: DLTs are assessed during the first cycle (28 days) in each cohort

Secondary outcomes (11)

  1. Escalation: Maximum observed concentration (Cmax)

    To characterize the PK properties of 1A46

    Measured: At enrollment and at multiple timepoints until treatment discontinuation, assessed up to 1 year

  2. Escalation: Time to reach Cmax (Tmax)

    To characterize the PK properties of 1A46

    Measured: At enrollment and at multiple timepoints until treatment discontinuation, assessed up to 1 year

  3. Escalation: Area Under the Concentration-Time Curve (AUC) from Time 0 to t

    To characterize the PK properties of 1A46

    Measured: At enrollment and at multiple timepoints until treatment discontinuation, assessed up to 1 year

  4. Escalation: Area under the serum concentration-time curve from time 0 to infinity (AUCinf)

    To characterize the PK properties of 1A46

    Measured: At enrollment and at multiple timepoints until treatment discontinuation, assessed up to 1 year

  5. Escalation: Terminal disposition phase half-life(t1/2)

    To characterize the PK properties of 1A46

    Measured: At enrollment and at multiple timepoints until treatment discontinuation, assessed up to 1 year

  6. Escalation: Total clearance after IV administration (CL)

    To characterize the PK properties of 1A46

    Measured: At enrollment and at multiple timepoints until treatment discontinuation, assessed up to 1 year

  7. Escalation: Anti-drug antibody (ADA)

    To characterize the PK properties of 1A46

    Measured: From Baseline up to end of study or discontinuation due to disease progression, up to 5 years

  8. Escalation: Objective Response Rate (ORR)

    To evaluate preliminary anti-tumor efficacy of 1A46

    Measured: From Baseline up to end of study or discontinuation due to disease progression, up to 5 years

  9. Escalation: Disease control rate (DCR)

    To evaluate preliminary anti-tumor efficacy of 1A46

    Measured: From Baseline up to end of study or discontinuation due to disease progression, up to 5 years

  10. Escalation: Progression free survival (PFS)

    To evaluate preliminary anti-tumor efficacy of 1A46

    Measured: From Baseline up to end of study or discontinuation due to disease progression, up to 5 years

  11. Escalation: Overall survival (OS)

    To evaluate preliminary anti-tumor efficacy of 1A46

    Measured: From Baseline up to end of study or discontinuation due to disease progression, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2022
  2. Study start30 Aug 2022
  3. Primary completion31 Oct 2024
  4. Study completion31 Oct 2024

Why it stopped: Sponsor's Research and Development strategy adjustment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05348889
Sponsor's protocol ID
CMG1A46-US01
Status last verified
Feb 2025
First submitted
29 Mar 2022
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 1A46 Injection in people with Non-Hodgkin's Lymphoma (disorder) and Acute Lymphoid Leukemia, Disease (disorder), run by Chimagen Biosciences, Ltd at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor's Research and Development strategy adjustment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Escalation: Incidence of Adverse Events (time frame: Adverse Events are assessed during the first cycle (28 days) in each cohort). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05348889.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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