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Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)Phase 1/2NCT07601607

Lisaftoclax Plus Chidamide and Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma

A Phase 1/2 study testing Lisaftoclax, Chidamide and rituximab in people with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL), run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a phase 1b/2a, open-label trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of lisaftoclax in combination with chidamide and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lisaftoclax, Chidamide and rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteChina
Study dates
30 May 2026to 30 Nov 2028
Phase
Phase 1/2
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

  • Age ≥18 years.
  • Histologically confirmed diffuse large B-cell lymphoma (DLBCL) according to the 2016 WHO classification with BCL-2 positivity by immunohistochemistry (defined as BCL-2 expression ≥30%).
  • Relapsed or refractory DLBCL after prior treatment with an anthracycline-containing regimen and an anti-CD20 antibody-containing regimen.
  • Received at least one prior line of therapy and considered ineligible for autologous stem cell transplantation (ASCT).
  • Estimated life expectancy ≥3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
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  • At least one measurable or evaluable lesion according to the Lugano 2014 lymphoma response criteria.
  • Adequate bone marrow, hepatic, and renal function.
  • Ability to understand and willingness to voluntarily sign a written informed consent form.

Who cannot join

  • Central nervous system (CNS) involvement by lymphoma, primary CNS lymphoma, or leukemic phase lymphoma.
  • Prior intolerance to BCL-2 inhibitors and chidamide, or disease refractory to or relapsed after treatment with both agents.
  • Known hypersensitivity to any component of the study drugs or their analogs.
  • Prior allogeneic hematopoietic stem cell transplantation within 6 months before the first dose, active graft-versus-host disease (GvHD), or requirement for immunosuppressive therapy within 28 days prior to study treatment.
  • Clinically significant active cardiovascular disease.
  • Uncontrolled or clinically unstable infection requiring parenteral antibacterial, antiviral, or antifungal therapy within 7 days before the first dose of study treatment.
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  • Pregnant or breastfeeding women.
  • Active human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
  • Malabsorption syndrome or other conditions that may interfere with enteral administration or absorption of study drugs.
  • Any other medical, psychiatric, or social condition that, in the investigator's judgment, would make the subject inappropriate for participation in this study.

Trial locations and contacts

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

Principal Investigator contact

0086-20-87342823

caiqq@sysucc.org.cn

China1 site

  • Sun yat-sen university cancer center

    Guangzhou, Guangdong, 510060

    Principal Investigator, 0086-20-87342823, caiqq@sysucc.org.cn

Other trials in China

About this study

Official title: A Phase Ib/IIa Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Lisaftoclax in Combination With Chidamide and Rituximab in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients（CLARITY Trial）

This is a phase 1b/2a, open-label trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of lisaftoclax in combination with chidamide and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).

Being tested
Lisaftoclax, Chidamide, rituximab
Medical subject headings
Recurrence, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • LisaftoclaxDrug

    Lisaftoclax will be administered orally once daily on Days 1-14 of each 21-day cycle for up to 6 cycles. During Cycle 1, a daily dose ramp-up schedule will be used. In the 600 mg cohort, participants will receive 200 mg on Day 1, 400 mg on Day 2, and 600 mg on Day 3, followed by 600 mg once daily on Days 4-14. In the 800 mg cohort, participants will receive 200 mg on Day 1, 400 mg on Day 2, 600 mg on Day 3, and 800 mg on Day 4, followed by 800 mg once daily on Days 5-14. From Cycles 2-6, participants will receive lisaftoclax at the target dose (600 mg or 800 mg) once daily on Days 1-14.

  • ChidamideDrug

    Chidamide will be administered orally at a dose of 20 mg on Days 1, 4, 8, and 11 of each 21-day cycle for up to 6 cycles.

  • rituximabDrug

    Rituximab will be administered intravenously at a dose of 375 mg/m² on Day 1 of each 21-day cycle for up to 6 cycles.

Study groups in NCT07601607
Study groupRoleWhat they receive
Lisaftoclax in combination with chidamide and rituximabExperimentalPatients will receive lisaftoclax orally once daily on Days 1-14 of each 21-day cycle for up to 6 cycles, with daily dose ramp-up during Cycle 1. Chidamide will be administered orally at 20 mg on Days 1, 4, 8, and 11 of each cycle, and rituximab will be administered intravenously at 375 mg/m² on Day 1 of each cycle.
Receives: Drug: Lisaftoclax; Drug: Chidamide; Drug: rituximab

What is being measured

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

  1. Dose-limiting toxicities (DLTs) (Phase 1b)

    DLTs will be assessed during the DLT evaluation period and graded according to NCI CTCAE version 5.0.

    Measured: During the first treatment cycle (21 days)

  2. Maximum tolerated dose (MTD) (Phase 1b)

    MTD is defined as the highest dose level at which fewer than one-third of patients experience a DLT during the DLT evaluation period.

    Measured: During the first treatment cycle (21 days)

  3. Recommended phase 2 dose (RP2D) (Phase 1b)

    RP2D will be determined based on the overall safety, tolerability, and DLT assessment results.

    Measured: During the first treatment cycle (21 days)

  4. Objective response rate (ORR)

    ORR is defined as the proportion of patients who achieve complete response or partial response according to Lugano 2014 criteria.

    Measured: Up to approximately 6 months

Secondary outcomes (7)

  1. Complete response rate (CRR)

    CRR is defined as the proportion of patients who achieve complete response according to Lugano 2014 criteria.

    Measured: Up to approximately 6 months

  2. Duration of response (DOR)

    DOR is defined as the time from the first documented response to disease progression or death from any cause.

    Measured: Up to 24 months

  3. Disease-free survival (DFS)

    DFS is defined as the time from first documented complete response to disease progression or death from any cause.

    Measured: Up to 24 months

  4. Progression-free survival (PFS)

    PFS is defined as the time from enrollment to disease progression or death from any cause.

    Measured: Up to 24 months

  5. Overall survival (OS)

    OS is defined as the time from enrollment to death from any cause.

    Measured: Up to 24 months

  6. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    The incidence and severity of adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

    Measured: Up to 30 days after the last study treatment

  7. Change in Quality of Life

    Quality of life will be assessed using the EORTC QLQ-C30 or EQ-5D questionnaire.

    Measured: Up to 24 months

Timeline

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

  1. First posted22 May 2026
  2. Study start30 May 2026 (estimated)
  3. Primary completion30 May 2028 (estimated)
  4. Study completion30 Nov 2028 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07601607
Sponsor's protocol ID
B2026-253
Status last verified
May 2026
First submitted
16 May 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
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 1/2 study testing Lisaftoclax, Chidamide and rituximab in people with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL), run by Sun Yat-sen University 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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 22 May 2026. 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 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?

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 Principal Investigator (0086-20-87342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (DLTs) (Phase 1b) (time frame: During the first treatment cycle (21 days)). The study lists 4 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 NCT07601607.

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 22 May 2026.

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