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Not yet recruitingNCT07784101Updated Aug 25, 2026

A Phase 3 Study to Compare the Efficacy of ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL).

A Phase 3 interventional study of ICP-248 and Pirtobrutinib in Relapsed or Refractory Mantle Cell Lymphoma (MCL), sponsored by Beijing InnoCare Pharma Tech Co., Ltd.. Not yet recruiting at 24 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Primary conditionLymphoma, Mantle-CellRegistry: RecurrenceReclassifiedWhy we changed it
Registry
Recurrence — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lymphoma, Mantle-Cell
Why
  1. Recurrence describes something many studies share rather than a condition a study is about.
  2. The study's listed conditions name Lymphoma, Mantle-Cell.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Beijing InnoCare Pharma Tech Co., Ltd. (part of InnoCare Pharma Limited) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to compare the efficacy and safety of ICP-248 in combination with orelabrutinib versus pirtobrutinib in patients with relapsed or refractory mantle cell lymphoma (r/r MCL).

02

Conditions studied

  • Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Browse trials for

03

In context

Lymphoma, Mantle-Cell Reclassified

1,220 studies on the registry are indexed under Lymphoma, Mantle-Cell; 154 are open to participants now.

This study's planned enrollment of 280 is above the median of 37 across 1,001 interventional studies indexed under Lymphoma, Mantle-Cell.

Browse Lymphoma, Mantle-Cell studies →

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd. is the lead sponsor of 61 studies on the registry; 38 are open to participants now.

Browse Beijing InnoCare Pharma Tech Co., Ltd. studies →All InnoCare Pharma Limited studies →

Compared within Lymphoma, Mantle-Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Known intolerance to orelabrutinib or pirtobrutinib treatment.
  2. Received hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the product. Received allogeneic hematopoietic stem cell transplantation at any time in the past.
  3. Patients with other within 2 years prior to enrollment.
  4. Uncontrolled or significant cardiovascular disease.
  5. Hemophilia A, Hemophilia B, von Willebrand disease history or requiring the use of warfarin or equivalent vitamin K antagonist anticoagulants (such as phenprocoumon, etc.) or assessed by the investigator to have a tendency for spontaneous bleeding.
  6. Participants with severe central nervous system diseases.
  7. Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy.
  8. Underwent major surgery within 4 weeks prior to the first dose.
  9. Active infections require systemic treatment.
  10. Active diseases.
  11. Known central nervous system lymphoma.
  12. Known alcohol or drug dependence.

Exclusion criteria

Exclusion Criteria:

  1. Known intolerance to orelabrutinib or pirtobrutinib treatment.
  2. Received hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the product. Received allogeneic hematopoietic stem cell transplantation at any time in the past.
  3. Patients with other within 2 years prior to enrollment.
  4. Uncontrolled or significant cardiovascular disease.
  5. Hemophilia A, Hemophilia B, von Willebrand disease history or requiring the use of warfarin or equivalent vitamin K antagonist anticoagulants (such as phenprocoumon, etc.) or assessed by the investigator to have a tendency for spontaneous bleeding.
  6. Participants with severe central nervous system diseases.
  7. Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy.
  8. Underwent major surgery within 4 weeks prior to the first dose.
  9. Active infections require systemic treatment.
  10. Active diseases.
  11. Known central nervous system lymphoma.
  12. Known alcohol or drug dependence.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
280 participants (estimated)

Study arms

  • Experimental
    ICP-248 in combination with Orelabrutinib

    Drug: ICP-248 · Drug: Orelabrutinib

  • Active comparator
    Pirtobrutinib

    Drug: Pirtobrutinib

Interventions

06

What researchers measure

Primary outcomes

  1. Progression-free survival (PFS) as assessed by Independent Review Committee (IRC).

    Time frame: 6 years

Secondary outcomes

  1. Investigator-assessed PFS according to Lugano 2014.

    Time frame: 6 years

  2. IRC-assessed and investigators-assessed overall response rate (ORR) according to Lugano 2014

    Time frame: 6 years

  3. IRC-assessed and investigators-assessed complete response rate (CRR) according to Lugano 2014

    Time frame: 6 years

  4. IRC-assessed and investigators-assessed duration of response (DOR) according to Lugano 2014

    Time frame: 6 years

  5. IRC-assessed and investigators-assessed time to first response (TTR) according to Lugano 2014

    Time frame: 6 years

  6. Time to next treatment (TTNT)

    Time frame: 6 years

  7. Overall Survival (OS)

    Time frame: 6 years

  8. Eastern Cooperative Oncology Group (ECOG) performance status

    Time frame: 6 years

07

Study locations

24 sites
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2032, 72 months later.

Of 27 phase 3 interventional studies under Lymphoma, Mantle-Cell, half reached primary completion within 97 months of starting (the median), counting those still running; a quarter within 68. This study's planned 72 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 25, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2032
CompletionEst.
Dec 2033
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07784101
Lead sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2032 (estimated)
Completion
Dec 2033 (estimated)
Last update
Aug 25, 2026

Study contacts

Alexia Lu
Contact
CO_HGRAC@innocarepharma.com
010-66609745

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Mesutoclax

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