Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)Phase 1/2NCT06909877
Study to Evaluate Efficacy and Safety of HH2853 in Relapsed/Refractory Peripheral T-cell Lymphoma
A Phase 1/2 study testing HH2853 Tablets in people with Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL), run by Haihe Biopharma Co., Ltd. at 1 site in China.
Trial summary
This study is a an open-label, multinational, multicenter, single-arm Phase Ⅰb/Ⅱ Study to Evaluate Efficacy and Safety of Oral HH2853 in Patients with Relapsed/Refractory Peripheral T-cell Lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)
- What is being tested?
- HH2853 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2022to 30 Jul 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- main inclusion:
- Tumor types and prior antitumor therapy: Phase Ib:Dose Escalation: All enrolled patients must have histologically confirmed diagnosis NHL who have received at least one line of prior systematic treatment (and ≤ 5 lines) and relapses or refractory. Phase Ib dose expansion part: All enrolled patients must have histologically confirmed diagnosis of PTCL, including subtypes: PTCL-NOS, AITL, ALK + ALCL, ALK-ALCL, NKTCL, enteropathy associated T-cell lymphoma (EATL), monomorphic epitheliotropic internal T-cell lymphoma (MEITL), Hepatosplenic T-cell lymphoma (HSTCL), follicular T-cell lymphoma (FTCL), Nodal peripheral T-cell lymphoma with TFH phenotype (Nodal PTCL-TFH) and other invasive T-cell sources NHL at the investigator and sponsor's discretion (except highly invasive). All enrolled patients had relapsed or refractory diseases after receiving 1-line systematic treatment (≤ 3 lines). Phase II: All enrolled patients must have histologically confirmed diagnosis of PTCL, including subtypes: PTCL-NOS, AITL, ALK+ALCL, ALK-ALCL, NKTCL, EATL, MEITL, HSTCL, FTCL, Nodal PTCL-TFH et al. Patients must have histologically confirmed diagnosis of R/R PTCL who have received at least one line of prior systematic combination chemotherapy and at least one new drug therapy (prior antitumor treatment lines ≤4 lines) : relapse and/or refractory.
- Availability of qualified tissue samples by patient for pathological diagnosis by the central laboratory.
- The Eastern cooperative oncology group (ECOG) score 0-1.
- Life expectancy ≥ 3 months before starting HH2853 treatment.
- Sufficient bone marrow, liver and renal functions.
Who cannot join
- main criteria:
- Previous treatment with EZH2 or EZH1/2 inhibitors.
- Central nervous system invasion.
- Any previous history of bone marrow malignancy, including myelodysplastic syndrome (MDS).
- Received medications that are known potent CYP3A4 inducers/inhibitors within 1 week prior to first dose.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sichuan Cancer Hospital
Chengdu, Chengdu
Huangming Hong, MD, 86-13570431657, honghm3@mail.sysu.edu.cn
About this study
Official title: An Open-label, Multinational, Multicenter, Single-arm Phase Ⅰb/Ⅱ Study to Evaluate Efficacy and Safety of Oral HH2853, a Selective EZH1/2 Inhibitor, in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma
This study is a an open-label, multinational, multicenter, single-arm Phase Ⅰb/Ⅱ Study to Evaluate Efficacy and Safety of Oral HH2853 in Patients with Relapsed/Refractory Peripheral T-cell Lymphoma.
Read the detailed description
This study includes Phase Ib and Phase II. In the Phase Ib, patients with R/R NHL (dose escalation) or R/R PTCL (dose expansion) who have received at least 1 line of prior systematic treatment and meet the inclusion/exclusion criteria in the protocol will be enrolled. Safety run-in study (Japan only): The objective of the safety run-in study in Japan is to evaluate the safety, tolerability, and PK profile of HH2853 in Japanese patients. The primary objective of the Phase Ib study is to determine the RP2D of HH2853 in PTCL patients. The secondary objectives are to evaluate the safety, preliminary efficacy and characterize the pharmacokinetic profile of HH2853 in R/R PTCL patients. A "3+3" design will be used in the dose escalation part with a starting dose of 400 mg BID. Based on the safety, efficacy and PK/PD data and HH2853-G101 data, 1-2 dose levels could be expanded, 10-15 R/R PTCL patients for each dose level. Approximately 21-48 patients will be enrolled in total.
In the Phase II (multi-national): patients with R/R PTCL who have received at least one prior systemic combination chemotherapy and at least one new drug therapy and meet the inclusion/exclusion criteria in the protocol will be enrolled. The Phase II study will be started once the RP2D is determined. The Phase II study is a single-arm study and will be enrolled in approximately 66 efficacy-evaluable R/R PTCL patients who had received at least one prior systemic combination chemotherapy and at least one new drug therapy. The primary objective of the Phase II study is to evaluate the efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug therapy (ORR, BIRC evaluation); The secondary objectives will be continued to further evaluate the efficacy, safety, tolerability and PK characteristics of HH2853 of R/R PTCL patients who have received at least 1 line of prior systemic therapy.
- Being tested
- HH2853 Tablets
- Keywords
- Relapsed/Refractory, Peripheral T-cell Lymphoma
- Medical subject headings
- Recurrence, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HH2853 TabletsDrug
Also called HH2853
25mg, 100mg and 200 mg BID oral administration
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation and expansion study of HH2853 | Experimental | To determine the RP2D of HH2853 in PTCL patients. Receives: Drug: HH2853 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: To determine the RP2D of HH2853 in PTCL patients
Determine RP2D of HH2853
Measured: 28-day treatment cycles
Phase II: To evaluate the efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug
ORR will be based on the blinded independent review committee (BIRC). Assessment of oncologic response will be performed according to the 2014 edition of the Lugano Criteria for Efficacy [Lugano]
Measured: 28-day treatment cycles
Secondary outcomes (25)
Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;
Investigator assessed: complete response rate (CRR)
Measured: 28-day treatment cycles
Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;
Duration of response (DoR)
Measured: 28-day treatment cycles
Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;
Disease control rate (DCR)
Measured: 28-day treatment cycles
Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;
Time to response (TTR)
Measured: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Area under the concentration-time curve (AUC)
Measured: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Maximum plasma concentration (Cmax)
Measured: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Trough concentration (Cmin)
Measured: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Time to maximum plasma concentration (Tmax)
Measured: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Apparent clearance (CL/F)
Measured: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Terminal half-life (t1/2)
Measured: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
ORR assessed by investigator
Measured: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Complete response rate (CRR)
Measured: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Progression-free survival (PFS)
Measured: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Duration of response (DoR)
Measured: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Disease control rate (DCR)
Measured: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Time to response (TTR)
Measured: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Overall survival (OS) by BIRC
Measured: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Overall survival (OS) by investigator
Measured: 28-day treatment cycles
Phase II: 2. To evaluate the safety and tolerability of HH2853
Duration and severity of adverse events (AEs)
Measured: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Area under the concentration-time curve (AUC)
Measured: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Maximum plasma concentration (Cmax)
Measured: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Steady-state trough concentration (Cmin)
Measured: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Time to maximum plasma concentration (Tmax)
Measured: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Apparent clearance (CL/F)
Measured: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Half life (t1/2)
Measured: 28-day treatment cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start27 Jul 2022
- Primary completion31 Oct 2025
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haihe Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tongyu Li, MD, Principal investigator, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909877
- Sponsor's protocol ID
- HH2853-G202
- Status last verified
- Jan 2026
- First submitted
- 20 Mar 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD based on business strategy.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multinational, Multicenter, Single-arm Phase Ⅰb/Ⅱ Study to Evaluate Efficacy and Safety of Oral HH2853, a Selective EZH1/2 Inhibitor, in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06909877
- Acronym / sponsor ID
- HH2853-G202
- Keywords
- Relapsed/Refractory, Peripheral T-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Haihe Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 4 Apr 2025 (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.
This study is a an open-label, multinational, multicenter, single-arm Phase Ⅰb/Ⅱ Study to Evaluate Efficacy and Safety of Oral HH2853 in Patients with Relapsed/Refractory Peripheral T-cell Lymphoma.
Detailed description
This study includes Phase Ib and Phase II. In the Phase Ib, patients with R/R NHL (dose escalation) or R/R PTCL (dose expansion) who have received at least 1 line of prior systematic treatment and meet the inclusion/exclusion criteria in the protocol will be enrolled. Safety run-in study (Japan only): The objective of the safety run-in study in Japan is to evaluate the safety, tolerability, and PK profile of HH2853 in Japanese patients. The primary objective of the Phase Ib study is to determine the RP2D of HH2853 in PTCL patients. The secondary objectives are to evaluate the safety, preliminary efficacy and characterize the pharmacokinetic profile of HH2853 in R/R PTCL patients. A "3+3" design will be used in the dose escalation part with a starting dose of 400 mg BID. Based on the safety, efficacy and PK/PD data and HH2853-G101 data, 1-2 dose levels could be expanded, 10-15 R/R PTCL patients for each dose level. Approximately 21-48 patients will be enrolled in total.
In the Phase II (multi-national): patients with R/R PTCL who have received at least one prior systemic combination chemotherapy and at least one new drug therapy and meet the inclusion/exclusion criteria in the protocol will be enrolled. The Phase II study will be started once the RP2D is determined. The Phase II study is a single-arm study and will be enrolled in approximately 66 efficacy-evaluable R/R PTCL patients who had received at least one prior systemic combination chemotherapy and at least one new drug therapy. The primary objective of the Phase II study is to evaluate the efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug therapy (ORR, BIRC evaluation); The secondary objectives will be continued to further evaluate the efficacy, safety, tolerability and PK characteristics of HH2853 of R/R PTCL patients who have received at least 1 line of prior systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation and expansion study of HH2853 | Experimental | Drug: HH2853 TabletsTo determine the RP2D of HH2853 in PTCL patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- main inclusion:
Key exclusion criteria (5 listed)
- main criteria:
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 |
|---|---|---|
| HH2853 TabletsAlso: HH285325mg, 100mg and 200 mg BID oral administration | Drug | Dose escalation and expansion study of HH2853 |
Primary outcome
Phase Ib: To determine the RP2D of HH2853 in PTCL patients
Time frame: 28-day treatment cycles
Determine RP2D of HH2853
Phase II: To evaluate the efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug
Time frame: 28-day treatment cycles
ORR will be based on the blinded independent review committee (BIRC). Assessment of oncologic response will be performed according to the 2014 edition of the Lugano Criteria for Efficacy [Lugano]
25 secondary outcomes
Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;
Time frame: 28-day treatment cycles
Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;
Time frame: 28-day treatment cycles
Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;
Time frame: 28-day treatment cycles
Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;
Time frame: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Time frame: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Time frame: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Time frame: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Time frame: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Time frame: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Time frame: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Time frame: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Time frame: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Time frame: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Time frame: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Time frame: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Time frame: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Time frame: 28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
Time frame: 28-day treatment cycles
Phase II: 2. To evaluate the safety and tolerability of HH2853
Time frame: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Time frame: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Time frame: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Time frame: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Time frame: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Time frame: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Time frame: 28-day treatment cycles
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 30 Jan 2026.
- Individual participant dataSharing planned: No. There is no plan to share IPD based on business strategy.
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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.
Tongyu Li, MD principal investigator
Sichuan Cancer Hospital and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HH2853 Tablets in people with Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL), run by Haihe Biopharma Co., Ltd. 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 6 inclusion and 5 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 30 Jan 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 Haiying Jia (86-20568888, haiying.jia@haihepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: To determine the RP2D of HH2853 in PTCL patients (time frame: 28-day treatment cycles). 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?
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 30 Jan 2026.