T-cell Non-Hodgkin's LymphomaEarly Phase 1NCT05013372
CD147-CAR T Cells for Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma
A Early Phase 1 study testing CD147- CAR T cells in people with T-cell Non-Hodgkin's Lymphoma, run by Peking University People's Hospital.
Trial summary
The safety and preliminary effectiveness of CD147-CAR T cells in patients with relapsed or refractory T cell non-Hodgkin's lymphoma will be investigated in this pioneering study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- T-cell Non-Hodgkin's Lymphoma
- What is being tested?
- CD147- CAR T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to 1 Jan 2025
- Phase
- Early 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must meet all of the following criteria:
- 18-65 years old;
- Relapsed or refractory T-NHLs, including peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), ALK-positive ALCL, ALK-negative Image result for anaplastic large cell lymphoma (ALCL), enteropathy-related T-cell lymphoma, hepatosplenic T-cell lymphoma, etc.;
- Previously received ≥2 lines of treatment without a complete response;
- Immunohistochemical detection of tumor cells CD147 positive;
- ECOG score 0-2;
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- The collection of mononuclear cells can be performed upon the judgment of the researcher;
- No contraindications for allogeneic hematopoietic stem cell transplantation (AlloHCT);
- Have donors for AlloHCT;
- Agree for sequential treatment of AlloHCT;
- Without serious organ dysfunction in 2 weeks before CAR-T infusion:
- Heart: without arrhythmia, LVEF≥50%, and without pericardial effusion; without heart failure (NYHA class III or IV) within12 months before CAR-T infusion; without myocardial infarction within 12 months before CAR-T infusion; without long-QT syndrome or secondary QT interval prolongation;
- Liver: ALT<2 times the upper limit of normal (ULN) and TBIL<1.5 times ULN, without active hepatitis;
- APTT and PT<1.5 times ULN;
- Kidney: Serum creatinine <1.5 mg/dl; or if the serum creatinine exceeds the upper limit, eGFR (CKD-EPI formula) needs to be > 50 ml/min;
- Fingertip blood oxygen saturation ≥ 92%.
- Estimated survival ≥ 3 months;
- Sexually active patients must be willing to use an effective method of birth control during the study period and within 6 months after the study ending, and male partners should use condoms;
- The patient is willing to join this clinical trial and sign an informed consent.
Who cannot join
- Anyone who has one or more of the following:
- A history of other malignancies with a disease-free period < 5 years (except for cured basal cell carcinoma of the skin, cured cervical carcinoma in situ, and gastrointestinal tumors proven to be cured by endoscopic mucosal resection);
- Those who have received allogeneic hematopoietic stem cell transplantation or organ transplantation;
- Patients with bone marrow involvement;
- Those who are allergic to the biological agents in CAR-T cell product ;
- Pregnant or breastfeeding;
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- Active bacterial, fungal or viral infection;
- Receiving systemic hormone therapy 1 week before participating in the clinical trial;
- Have received other gene therapy before;
- HBV or HCV infection or carrier is defined as: HBsAg positive or HBV-DNA positive; anti-HCV positive and HCV-RNA positive;
- Active HIV infection;
- Clinical diagnosis of virus infection or uncontrolled virus activation, including cytomegalovirus (CMV), adenovirus (ADV), BK virus or human herpesvirus 6 (HHV-6), etc.;
- Central nervous system lymphoma (CNSL) is defined as the presence of ≥5 tumor cells/ ul in cerebrospinal fluid (CSF) or MRI suggested CNSL; any other CNS diseases, such as uncontrolled epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease or any autoimmune disease involving the central nervous system, or received treatment for central nervous system or brain metastasis (radiotherapy, surgery or other treatments);
- Imaging determined lung infection;
- Inappropriate to participate in the trial with investigators' decision.
Trial locations and contacts
No sites are listed yet.
Xiaojun Huang, MD. PhD. contact
About this study
Official title: A Pioneering Study on the Safety and Efficacy of CD147-Chimeric Antigen Receptor (CAR) T Cells in Patients With Relapsed or Refractory T-cell Non-Hodgkin's Lymphoma
The safety and preliminary effectiveness of CD147-CAR T cells in patients with relapsed or refractory T cell non-Hodgkin's lymphoma will be investigated in this pioneering study.
Read the detailed description
CD147 has been demonstrated higher and relatively specific expression on T cell non-Hodgkin's lymphoma. Preclinical studies have shown that CAR T cells targeting CD147 antigen can continuously eliminate Jurkat T-cell lymphoma in mice and extend survival without severe adverse events including hemolysis. Preliminary investigation of CD147-CAR T cells in solid tumors has started and shown an acceptable safety profile. The safety and preliminary effectiveness of CD147-CAR T cells in patients with relapsed or refractory T cell non-Hodgkin's lymphoma will be investigated in this pioneering study.
- Conditions
- T-cell Non-Hodgkin's Lymphoma
- Being tested
- CD147- CAR T cells
- Keywords
- CAR T cells, T-cell Non-Hodgkin's lymphoma, CD147
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD147- CAR T cellsDrug
Also called CAR T cells targeting CD147
CAR T cells targeting CD147
| Study group | Role | What they receive |
|---|---|---|
| Dose-escalation | Other | Dose -1：0.1×10E+6/kg Dose 1：0.25×10E+6/kg Dose 2：0.5×10E+6/kg Dose 3：1.0×10E+6/kg Dose 4：2.0×10E+6/kg Receives: Drug: CD147- CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
The highest dose that does not cause unacceptable side effects.
Measured: within 12 months
Dose-limiting toxicity (DLT)
Side effects serious enough to prevent an increase in dose.
Measured: within 12 months
Adverse events
Adverse events
Measured: within 12 months
Serious adverse events (SAE)
Serious adverse events (SAE)
Measured: within 12 months
Adverse events of special interest (AESI)
Measured: within 12 months
Secondary outcomes (6)
Overall response rate (ORR)
Overall response rate (ORR) evaluated according to the Lugano2014 criteria
Measured: At the 12th week, 6th month, 9th month and 12th month
Complete response rate (CR)
Complete response rate (CR) evaluated according to the Lugano2014 criteria
Measured: At the 12th week, 6th month, 9th month and 12th month
Duration of response (DOR)
Duration of response (DOR)
Measured: At the 12th week, 6th month, 9th month and 12th month
Cmax of CD147-CAR T cells
Measured: within 4 weeks
Tmax of CD147-CAR T cells
Measured: within 4 weeks
AUC of CD147-CAR T cells
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study startJan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Non-Hodgkin's 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
- Investigators
- Xiaojun Huang, MD. PhD., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013372
- Sponsor's protocol ID
- CD147-CAR T for R/R T-NHL
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2021
- Last updated
- 2 Aug 2022
- 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 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pioneering Study on the Safety and Efficacy of CD147-Chimeric Antigen Receptor (CAR) T Cells in Patients With Relapsed or Refractory T-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT05013372
- Acronym / sponsor ID
- CD147-CAR T for R/R T-NHL
- Conditions
- T-cell Non-Hodgkin's Lymphoma
- Keywords
- CAR T cells, T-cell Non-Hodgkin's lymphoma, CD147
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 19 Aug 2021 (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 safety and preliminary effectiveness of CD147-CAR T cells in patients with relapsed or refractory T cell non-Hodgkin's lymphoma will be investigated in this pioneering study.
Detailed description
CD147 has been demonstrated higher and relatively specific expression on T cell non-Hodgkin's lymphoma. Preclinical studies have shown that CAR T cells targeting CD147 antigen can continuously eliminate Jurkat T-cell lymphoma in mice and extend survival without severe adverse events including hemolysis. Preliminary investigation of CD147-CAR T cells in solid tumors has started and shown an acceptable safety profile. The safety and preliminary effectiveness of CD147-CAR T cells in patients with relapsed or refractory T cell non-Hodgkin's lymphoma will be investigated in this pioneering study.
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 | Other | Drug: CD147- CAR T cellsDose -1：0.1×10E+6/kg Dose 1：0.25×10E+6/kg Dose 2：0.5×10E+6/kg Dose 3：1.0×10E+6/kg Dose 4：2.0×10E+6/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- The subject must meet all of the following criteria:
Key exclusion criteria (15 listed)
- Anyone who has one or more of the following:
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 |
|---|---|---|
| CD147- CAR T cellsAlso: CAR T cells targeting CD147CAR T cells targeting CD147 | Drug | Dose-escalation |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: within 12 months
The highest dose that does not cause unacceptable side effects.
Dose-limiting toxicity (DLT)
Time frame: within 12 months
Side effects serious enough to prevent an increase in dose.
Adverse events
Time frame: within 12 months
Adverse events
Serious adverse events (SAE)
Time frame: within 12 months
Serious adverse events (SAE)
Adverse events of special interest (AESI)
Time frame: within 12 months
6 secondary outcomes
Overall response rate (ORR)
Time frame: At the 12th week, 6th month, 9th month and 12th month
Complete response rate (CR)
Time frame: At the 12th week, 6th month, 9th month and 12th month
Duration of response (DOR)
Time frame: At the 12th week, 6th month, 9th month and 12th month
Cmax of CD147-CAR T cells
Time frame: within 4 weeks
Tmax of CD147-CAR T cells
Time frame: within 4 weeks
AUC of CD147-CAR T cells
Time frame: within 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- 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.
Xiaojun Huang, MD. PhD. contact
Xiaojun Huang, MD. PhD. principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD147- CAR T cells in people with T-cell Non-Hodgkin's Lymphoma, run by Peking University People's Hospital.
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 19 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 2 Aug 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shenmiao Yang, MD. (13439999810, yangshenmiao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: within 12 months). The study lists 5 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 2 Aug 2022.