Lymphoma, B-CellPhase 1NCT06210243
C752 for Refractory/Relapsed B Cell Non-Hodgkin Lymphoma
A Phase 1 study testing C752 in people with Lymphoma, B-Cell and CAR-T, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China at 1 site in China.
Trial summary
It is a single-arm, open-label clinical study to assess the safety and efficacy of the C752 CAR-T Cells for patients with CD19+ refractory/relapsed B cell non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell, CAR-T
- What is being tested?
- C752
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2023to 24 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Written informed consent in accordance with federal, local, and institutional guidelines, Males and females ≥18 years of age at the time of consent
- Documented diagnosis of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- Have progression by least one systemic treatment and no available standard of care treatment.
- At least one measurable lesion by Lugano 2014
- Expected survival ≥ 12 weeks
- Have an ECOG performance status of 0 or 1
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- Adequate organ function
- Screening test indicates histopathological CD19 + if the subject received CD19-targeted therapy
- Women of childbearing age must have a negative pregnancy test, and agree to take effective contraception during the trial
Who cannot join
- Treatment with any prior HSCT, gene therapy product, cell therapy product ect.
- Central nervous system involvement
- HBV/HCV
- HIV infection
- Concurrent use of systemic steroids or immunosuppression
- Uncontrolled active infection
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- Wash-out period of from the last anti-cancer treatment
- Active second malignancy
- Have not recovered from the effects of previous therapy
- Have psychological or physical conditions that do not permit compliance with the protocol
- Pregnant or nursing (lactating) women
Trial locations and contacts
1 site in 1 country.
China1 site
920th Hospital of Joint LogisticsSupport Force of People's Liberation
Kunming, Yunnan, 650000
About this study
Official title: A Single-arm, Open-label Clinical Study to Assess the Safety and Efficacy of the C752 CAR-T Cells for Patients With CD19+ Refractory/Relapsed B Cell Non-Hodgkin Lymphoma
It is a single-arm, open-label clinical study to assess the safety and efficacy of the C752 CAR-T Cells for patients with CD19+ refractory/relapsed B cell non-Hodgkin lymphoma.
- Conditions
- Lymphoma, B-Cell, CAR-T
- Being tested
- C752
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C752Biological
C752 will be administered on Day 0
| Study group | Role | What they receive |
|---|---|---|
| C752 | Experimental | Not described Receives: Biological: C752 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events (AEs)
Measured: 1 year
Dose Limiting Toxicities
Measured: First 28 days s after C752 injection
Secondary outcomes (3)
Objective response rate (ORR)
Objective response rate after C752 injection as defined by Lugano 2014
Measured: 1 year
PFS
Measured: 1 year
Pharmacokinetic - AUC
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start24 Dec 2023
- Primary completion24 Dec 2024
- Study completion24 Dec 2024
Why it stopped: Due to the PI's determination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai PerHum Therapeutics Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Sanbin Wang, M.D., Principal investigator, 920th Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210243
- Sponsor's protocol ID
- PH02001
- Status last verified
- Feb 2025
- First submitted
- 7 Jan 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Clinical Study to Assess the Safety and Efficacy of the C752 CAR-T Cells for Patients With CD19+ Refractory/Relapsed B Cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06210243
- Acronym / sponsor ID
- PH02001
- Conditions
- Lymphoma, B-Cell, CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the PI's determination
- Enrolment
- 2 participants (actual)
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of ChinaUniversity, hospital or other
- Collaborators
- Shanghai PerHum Therapeutics Co., Ltd.
- Study start
- 24 Dec 2023 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 18 Jan 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.
It is a single-arm, open-label clinical study to assess the safety and efficacy of the C752 CAR-T Cells for patients with CD19+ refractory/relapsed B cell non-Hodgkin lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C752 | Experimental | Biological: C752 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent in accordance with federal, local, and institutional guidelines, Males and females ≥18 years of age at the time of consent
- Documented diagnosis of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- Have progression by least one systemic treatment and no available standard of care treatment.
- At least one measurable lesion by Lugano 2014
- Expected survival ≥ 12 weeks
Key exclusion criteria (11 listed)
- Treatment with any prior HSCT, gene therapy product, cell therapy product ect.
- Central nervous system involvement
- HBV/HCV
- HIV infection
- Concurrent use of systemic steroids or immunosuppression
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 |
|---|---|---|
| C752C752 will be administered on Day 0 | Biological | C752 |
Primary outcome
The incidence and severity of adverse events (AEs)
Time frame: 1 year
Dose Limiting Toxicities
Time frame: First 28 days s after C752 injection
3 secondary outcomes
Objective response rate (ORR)
Time frame: 1 year
PFS
Time frame: 1 year
Pharmacokinetic - AUC
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Due to the PI's determination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sanbin Wang, M.D. principal investigator
920th Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C752 in people with Lymphoma, B-Cell and CAR-T, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China 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 11 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: stopped early, as of the sponsor's last update on 18 Feb 2025. 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 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?
The study was stopped early (reason given: Due to the PI's determination). Results are not available in the source record.
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?
The incidence and severity of adverse events (AEs) (time frame: 1 year). 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 18 Feb 2025.