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B-cell Non Hodgkin LymphomaPhase 1NCT06725524

A Study of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma

A Phase 1 study testing JMT601 in people with B-cell Non Hodgkin Lymphoma, run by Shanghai JMT-Bio Inc. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a Phase 1, open-label, multi-center study to evaluate the safety of JMT601 in the treatment of relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma and to determine the recommended dose for Phase 2 studies (RP2D). Study consists of 2 parts. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
B-cell Non Hodgkin Lymphoma
What is being tested?
JMT601
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
1 siteChina
Study dates
12 Oct 2021to 31 Dec 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants diagnosed with CD20-positive B-cell non-Hodgkin lymphoma confirmed by histopathology and/or cell biology who have previously received 2 or more lines of therapy
  • Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2
  • Participants must have at least one evaluable or measurable lesion according to Lugano 2014 criteria.
  • Expected survival of at least 3 months;
  • Suitable organ and hematopoietic function:
  • The absolute count of neutrophil (ANC) ≥1.0×109/L;
Show all 11Show fewer
  • Platelets ≥75×10^9/L (if bone marrow invasion doesn't exist)/≥50.0×10^9/L (if bone marrow invasion exists);
  • Hemoglobin ≥90 g/L;
  • Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min;
  • Total bilirubin ≤1.5×ULN, alanine aminotransferase ≤2.5×ULN, aspartate aminotransferase ≤2.5×ULN; Subjects with liver lesion: TBIL≤3×ULN, ALT≤5×ULN, AST≤5×ULN;
  • International Standardized ratio and activated partial thromboplastin time ≤1.5 × ULN;

Who cannot join

  • Confirmed central nervous system (CNS) lymphoma.
  • Subjects who have received allogeneic hematopoietic stem cell transplantation (HSCT) or other organ transplantation
  • Those who have previously received targeted CD47 or signal regulatory protein α (SIRRP α) therapy.
  • Previous or current hemolytic anemia, Evans syndrome, arteritis;
  • Subjects with previous or current other malignant tumors;
  • Previous or current history of active autoimmune diseases;
  • Subjects who had undergone major surgery within 4 weeks prior to initial dosing or expected to have major surgery during the study period;
  • HIV infection, active syphilis, hepatitis B surface antigen (HBsAg) positive and HBV-DNA higher than the lower limit or 1000 copies /ml(500 IU/ml), HCV antibody positive and HCV-RNA higher than the lower limit or 1000 copies /ml

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qingjie Li contact

86-15877976037

liqingjie@cspc.cn

China1 site, 1 recruiting

  • Ruijin Hospital

    Shanghai

    Weili Zhao, 86-13512112076, zwl_trial@163.com

    Weili Zhao

    Recruiting

Other trials in China

About this study

Official title: A Phase 1, Open-Label, Multi-center Study Evaluating the Safety and Tolerability of of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma

This is a Phase 1, open-label, multi-center study to evaluate the safety of JMT601 in the treatment of relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma and to determine the recommended dose for Phase 2 studies (RP2D). Study consists of 2 parts. The first part is a dose-escalation part using a 3+3 design with up to 6 dose(0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 12 mg/kg and 20 mg/kg) escalation cohorts at increasing levels. The second part is a dose-expansion part at R2PD dose to assess preliminary efficacy of JMT601.

Being tested
JMT601
Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • JMT601Biological

    intravenous infusion on day 1 once a week

Study groups in NCT06725524
Study groupRoleWhat they receive
JMT601ExperimentalSubjects will receive JMT601 once a week. The first 4-week period is for DLT observation. Dose escalation part will be carried out according to 3+3 dose-escalation design with up to 6 dose(0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 12 mg/kg and 20 mg/kg) escalation cohorts. Dose expansion part will continue at the determined RP2D. Dose expansion part consists of two cohorts: Cohort A: Subjects with CD20-positive diffuse large B-cell lymphoma, prior at least two lines of therapy. Cohort B: Subjects with CD20-positive follicular lymphoma, prior at least two lines of therapy.
Receives: Biological: JMT601

What is being measured

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

  1. Dose-limiting toxicity(DLT) and maximum tolerated dose(MTD)

    Measured: DLTs and MTD: Up to 28 days after the first dose

  2. Incidence of treatment-emergent adverse events (TEAEs)

    Measured: TEAEs: Up to 90 days after last dose

Secondary outcomes (13)

  1. Overall response rate (ORR)

    Defined as the proportion of participants with complete response or partial response measured by Lugano 2014

    Measured: Up to 12 months

  2. Duration of response (DOR)

    Defined as the time from complete response or partial response to progression disease or death

    Measured: Up to 12 months

  3. Progression free survival (PFS)

    Defined as the time from initiation of treatment to progression disease or death

    Measured: Up to 12 months

  4. Overall survival (OS)

    Defined as the time from initiation of treatment to death of any cause

    Measured: Up to 12 months

  5. Aera under the curve from 0 to the last measurable concentration(AUClast)

    Aera under the curve from 0 to the last measurable concentration

    Measured: Up to 12 months

  6. Aera under the curve from 0 to the infinite time(AUC0-∞)

    Aera under the curve from 0 to the infinite time

    Measured: Up to 12 months

  7. Time to maximum concentration(Tmax)

    time to maximum concentration

    Measured: Up to 12 months

  8. Terminal phase half-life(T1/2)

    terminal phase half-life

    Measured: Up to 12 months

  9. Clearance(CL)

    clearance

    Measured: Up to 12 months

  10. Volume(Vd)

    volume

    Measured: Up to 12 months

  11. Maximum concentration( Cmax)

    maximum concentration

    Measured: Up to 12 months

  12. Minimum concentration(Cmin)

    minimum concentration

    Measured: Up to 12 months

  13. Accumulation ratio(AR)

    accumulation ratio

    Measured: Up to 12 months

Timeline

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

  1. First posted10 Dec 2024
  2. Study start12 Oct 2021
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06725524
Sponsor's protocol ID
JMT601-001
Status last verified
Dec 2024
First submitted
19 Jul 2023
Last updated
10 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JMT601 in people with B-cell Non Hodgkin Lymphoma, run by Shanghai JMT-Bio Inc. at 1 site in China.

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 11 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 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.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Qingjie Li (86-15877976037, liqingjie@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity(DLT) and maximum tolerated dose(MTD) (time frame: DLTs and MTD: Up to 28 days after the first dose). 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 NCT06725524.

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 10 Dec 2024.

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