Classic Hodgkin LymphomaPhase 3NCT06465446
A Study of IMM01 Plus Tiselizumab Versus Physician's Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma
A Phase 3 study testing Tislelizumab, IMM01 and Bendamustine in people with Classic Hodgkin Lymphoma, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc..
Trial summary
The purpose of this study is to compare efficacy of IMM01 plus Tiselizumab with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of IMM01 plus Tiselizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Classic Hodgkin Lymphoma
- What is being tested?
- Tislelizumab, IMM01 and Bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Jul 2029
- Phase
- Phase 3
- 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
- Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL).
- PD (L)-1 refractory cHL and exhausted all available treatment options with known clinical benefit.
- Has adequate bone marrow reserves and organ functions.
Who cannot join
- History of central nervous system (CNS) metastases or active CNS involvement.
- Received prior systemic anticancer therapy within 4 weeks before randomization.
- Received prior ani-CD47 or SIRPa treatment.
- History of human immunodeficiency virus (HIV).
- Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
- History of severve allergic reactions to any components of trail durg, humanized antibodies or fusion proteins.
About this study
Official title: A Phase III Randomized, Open-label, Multicenter Clinical Study of IMM01 (Timdarpacept) in Combiniation With Tiselizumab Versus Physician's Choice Chemotherapy in PD-(L)1-refractory Classical Hodgkin Lymphoma
The purpose of this study is to compare efficacy of IMM01 plus Tiselizumab with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of IMM01 plus Tiselizumab. The primary study hypotheses are that IMM01 plus Tiselizuma is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).
- Conditions
- Classic Hodgkin Lymphoma
- Being tested
- Tislelizumab, IMM01, Bendamustine, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabBiological
IV infusion
IMM01Biological
Also called Timdarpacept
2.0mg/kg, IV infusion
BendamustineDrug
IV infusion
GemcitabineDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| IMM01 plus Tiselizuma | Experimental | Participants will receive IMM01 (2.0mg/kg) intravenously each week and tislelizumab (200mg) once every 3 weeks in 3-week treatment cycle, for up to 2 years. Receives: Biological: Tislelizumab; Biological: IMM01 |
| Physician's Choice Chemotherapy | Active comparator | Participants will receive physician's choice of either bendamustine or gemcitabie.
Gemciabine: 90 or 120 mg/m^2 on Day 1 and Day 2, IV, 4-week cycle, for up to 6 cycles.
Gemcitabine: 1000 mg/m^2 on Day 1 and Day 8, IV, 3-week cycle, for up to 6 cycles. Receives: Drug: Bendamustine; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC)
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: approximately 24 months
Secondary outcomes (3)
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: approximately 36 months
Duration of Response (DOR)
DOR is defined as the time from the first documented evidence of complete response or partial response until disease progression or death due to any cause, whichever occurs first.
Measured: approximately 24 months
Number of Participants Who Experienced At Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classic Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465446
- Sponsor's protocol ID
- IMM01-008
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Open-label, Multicenter Clinical Study of IMM01 (Timdarpacept) in Combiniation With Tiselizumab Versus Physician's Choice Chemotherapy in PD-(L)1-refractory Classical Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06465446
- Acronym / sponsor ID
- IMM01-008
- Conditions
- Classic Hodgkin Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare efficacy of IMM01 plus Tiselizumab with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of IMM01 plus Tiselizumab. The primary study hypotheses are that IMM01 plus Tiselizuma is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMM01 plus Tiselizuma | Experimental | Biological: Tislelizumab, Biological: IMM01Participants will receive IMM01 (2.0mg/kg) intravenously each week and tislelizumab (200mg) once every 3 weeks in 3-week treatment cycle, for up to 2 years. |
| Physician's Choice Chemotherapy | Active comparator | Drug: Bendamustine, Drug: GemcitabineParticipants will receive physician's choice of either bendamustine or gemcitabie. Gemciabine: 90 or 120 mg/m^2 on Day 1 and Day 2, IV, 4-week cycle, for up to 6 cycles. Gemcitabine: 1000 mg/m^2 on Day 1 and Day 8, IV, 3-week cycle, for up to 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL).
- PD (L)-1 refractory cHL and exhausted all available treatment options with known clinical benefit.
- Has adequate bone marrow reserves and organ functions.
Key exclusion criteria (6 listed)
- History of central nervous system (CNS) metastases or active CNS involvement.
- Received prior systemic anticancer therapy within 4 weeks before randomization.
- Received prior ani-CD47 or SIRPa treatment.
- History of human immunodeficiency virus (HIV).
- Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabIV infusion | Biological | IMM01 plus Tiselizuma |
| IMM01Also: Timdarpacept2.0mg/kg, IV infusion | Biological | IMM01 plus Tiselizuma |
| BendamustineIV infusion | Drug | Physician's Choice Chemotherapy |
| GemcitabineIV infusion | Drug | Physician's Choice Chemotherapy |
Primary outcome
Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC)
Time frame: approximately 24 months
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
3 secondary outcomes
Overall Survival (OS)
Time frame: approximately 36 months
Duration of Response (DOR)
Time frame: approximately 24 months
Number of Participants Who Experienced At Least One Adverse Event (AE)
Time frame: approximately 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
Related trials for Classic Hodgkin Lymphoma
RecruitingPhase 3
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
Active, not recruitingPhase 2
Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)
Hodgkin Lymphoma
Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
Grade 3b Follicular Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between DLBCL and Classic HL
Active, not recruitingPhase 3
Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
Ann Arbor Stage IIB Hodgkin Lymphoma, Ann Arbor Stage IIIB Hodgkin Lymphoma
RecruitingPhase 1/2
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
Hodgkin Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tislelizumab, IMM01 and Bendamustine in people with Classic Hodgkin Lymphoma, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc..
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 3 inclusion and 6 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 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Progression Free Survival (PFS) per Lugano 2014 as Assessed by Independent Review Committee (IRC) (time frame: approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2024.