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Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple MyelomaPhase 1NCT05363800

Phase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma

A Phase 1 study testing HRS-3738 in people with Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma, run by Jiangsu HengRui Medicine Co., Ltd. at 3 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-3738 in patients with recurrent and refractory Non-Hodgkin's lymphoma and multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HRS-3738
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
3 sitesChina
Study dates
17 Jun 2022to 30 Dec 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Active multiple myeloma in accordance with IMWG criteria，or histopathologically and immunohistochemically confirmed non-Hodgkin's lymphoma in accordance with the 2016 WHO Classification of lymphoid neoplasias.
  • Recurred or did not alleviate after the previous treatment.
  • Have at least one measurable lesion.
  • With a life expectancy of ≥3 months.
  • Male or female ≥ 18 years old.
  • ECOG performance status of 0-1.
  • Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Who cannot join

  • Amyloidosis, plasma cell leukemia.
  • Corrected serum calcium>3.4mmol/L(13.5mg/dl).
  • Presence of metastasis to central nervous system.
  • Treatment of other investigational products.
  • Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.
  • Known history of hypersensitivity to any components of HRS-3738.
  • Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Zhejiang University School of Medicine The First Affiliated Hospital

    Hangzhou, Zhejiang, 310003

  • Sheng Jing Hospital of China Medical University

    Shengyang, Liaoning, 110004

  • Henan cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-3738 in patients with recurrent and refractory Non-Hodgkin's lymphoma and multiple myeloma.

Being tested
HRS-3738
Medical subject headings
Recurrence, Lymphoma, Non-Hodgkin, Multiple Myeloma

What participants receive

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

  • HRS-3738Drug

    HRS-3738 will be administrated per dose level in which the patients are assigned.

Study groups in NCT05363800
Study groupRoleWhat they receive
HRS-3738ExperimentalIn dose Escalation: HRS-3738 will be taken in oral. Seven dose levels are preset. In dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage. In indication Expansion: Indications will be selected to evaluate preliminary efficacy.
Receives: Drug: HRS-3738

What is being measured

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

  1. Maximum tolerated dose (MTD)

    Incidence and category of dose limiting toxicities (DLTs) during the first 28-day cycle of HRS-3738 treatment.

    Measured: From Day 1 to Day 28

  2. RP2D

    RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in dose escalation and dose expansion stages.

    Measured: From Day 1 to Day 28

Secondary outcomes (13)

  1. Safety endpoints: adverse events(AEs), serious adverse events（SAEs）

    Assess safety and tolerability of HRS-3738 by way of adverse events (CTCAE v5.0).

    Measured: From Day 1 to 30 days after last dose.

  2. Efficacy endpoints: Overall response rate (ORR)

    Evaluated using Lugano 2014 criteria and IMWG criteria.

    Measured: From Day 1 to 30 days after last dose.

  3. Efficacy endpoints: Best of response (BOR)

    Evaluated using Lugano 2014 criteria and IMWG criteria

    Measured: From Day 1 to 30 days after last dose

  4. Efficacy endpoints: time to response (TTR)

    Evaluated using Lugano 2014 criteria and IMWG criteria.

    Measured: From Day 1 to 30 days after last dose.

  5. Efficacy endpoints: Duration of response (DoR)

    Evaluated using Lugano 2014 criteria and IMWG criteria

    Measured: From Day 1 to 30 days after last dose

  6. Efficacy endpoints: Progression-free survival (PFS)

    Evaluated using Lugano 2014 criteria and IMWG criteria

    Measured: From Day 1 to 30 days after last dose

  7. Efficacy endpoints: overall survival (OS).

    Evaluated using Lugano 2014 criteria and IMWG criteria.

    Measured: From Day 1 to 30 days after last dose.

  8. Cmax

    Maximal plasma concentration

    Measured: From Day 1 to 30 days after last dose

  9. Tmax

    Time to Cmax

    Measured: From Day 1 to 30 days after last dose

  10. AUC

    Area under the plasma concentration-time curve

    Measured: From Day 1 to 30 days after last dose

  11. t1/2

    Terminal-phase elimination half-life

    Measured: From Day 1 to 30 days after last dose

  12. Vz/F

    Apparent volume of distribution during terminal phase after non-intravenous administration

    Measured: From Day 1 to 30 days after last dose

  13. CL/F

    Apparent total clearance of the drug from plasma after oral administration.

    Measured: From Day 1 to 30 days after last dose

Timeline

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

  1. First posted6 May 2022
  2. Study start17 Jun 2022
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (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
Model description
Single arm study of HRS-3738
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05363800
Sponsor's protocol ID
HRS-3738-I-102
Status last verified
Jun 2026
First submitted
25 Apr 2022
Last updated
5 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HRS-3738 in people with Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma, run by Jiangsu HengRui Medicine Co., Ltd. at 3 sites 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

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?

Maximum tolerated dose (MTD) (time frame: From Day 1 to Day 28). 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 NCT05363800.

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 5 Jun 2026.

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