Peripheral T-cell LymphomaPhase 1COURAGENCT06914037
A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies
A Phase 1 study testing CHT101 in people with Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma (CTCL), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma (CTCL), NHL (Non-Hodgkin Lymphoma)
- What is being tested?
- CHT101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to 31 Mar 2028
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent.
- Aged 18 to 70 years, male or female.
- Confirmed CD70 positive in tumor tissue by immunohistochemistry (IHC).
- Only the following subtypes of hematological malignancies with measurable disease will be enrolled:
- Peripheral T cell lymphoma (including peripheral T cell lymphoma NOS, angioimmunoblastic T cell lymphoma, anaplastic large cell lymphoma, etc.) who have failed ≥1 line of systemic therapy.
- Cutaneous T cell lymphoma (including mycosis fungoides (MF) or Sézary syndrome (SS) [stage ≥IIB with disease involving two or more compartments or single-compartment disease with large-cell transformation]) who have failed ≥2 lines of systemic therapies.
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- Aggressive B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody and anthracyclines.
- Indolent B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody.
- Chronic lymphocytic leukemia (CLL) who are refractory or relapsed post ≥2 lines of systemic therapies which contain BTK inhibitor and BCL-2 inhibitor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Estimated life expectancy ≥12 weeks.
- Female patients of childbearing potential and male patients must agree to use a highly effective method of contraception from signing ICF through 2 years after last CHT101 infusion.
Who cannot join
- History or presence of CNS metastasis, or clinically relevant CNS pathology such as seizure, stroke, severe brain injury, etc.
- History of solid organ transplantation.
- Prior treatment with CD70-targeting agents.
- Prior treatment with CAR-T or other cellular/gene therapies.
- Ongoing bacterial, viral or fungal infection requiring systemic anti-infectives.
- Active autoimmune disease requiring immunosuppression.
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
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality
Huilai Zhang, 086-02223340123, zhlwgq@126.com
About this study
Official title: A Phase 1, Open-Label, Single-Arm Study of the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies
Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies
Read the detailed description
3 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) reviewing available safety, PK and preliminary efficacy data.
- Being tested
- CHT101
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHT101Drug
CD70 UCAR-T
| Study group | Role | What they receive |
|---|---|---|
| CHT101 | Experimental | CD70 UCAR-T Receives: Drug: CHT101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Safety
Measured: 28 days of first infusion of CHT101
Maximum tolerated dose (MTD)
Tolerability
Measured: 28 days of first infusion of CHT101
Secondary outcomes (7)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Adverse events post infusion of CHT101 infusion
Measured: 2 years
Objective response rate (ORR)
The proportion of subjects who achieve CR or PR after CHT101 infusion
Measured: 2 years
Duration of response (DOR)
The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause
Measured: 2 years
Progression-free survival (PFS)
The period from the day when the subject receives the infusion of cells to the first recorded tumor progression or death of any cause, which occurs first
Measured: 2 years
Overall survival (OS)
The period from the first infusion to any cause of death
Measured: 2 years
Pharmacokinetics (PK)
Concentration levels of CHT101
Measured: 2 years
Pharmacodynamics (PD)
Concentration levels of cytokines
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start31 Mar 2025 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914037
- Sponsor's protocol ID
- CHT101HIIT-01
- Acronym
- COURAGE
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Arm Study of the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies
- ClinicalTrials.gov ID
- NCT06914037
- Acronym / sponsor ID
- COURAGE / CHT101HIIT-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 6 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.
Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies
Detailed description
3 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) reviewing available safety, PK and preliminary efficacy data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHT101 | Experimental | Drug: CHT101CD70 UCAR-T |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Willing and able to provide written informed consent.
- Aged 18 to 70 years, male or female.
- Confirmed CD70 positive in tumor tissue by immunohistochemistry (IHC).
- Only the following subtypes of hematological malignancies with measurable disease will be enrolled:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Key exclusion criteria (6 listed)
- History or presence of CNS metastasis, or clinically relevant CNS pathology such as seizure, stroke, severe brain injury, etc.
- History of solid organ transplantation.
- Prior treatment with CD70-targeting agents.
- Prior treatment with CAR-T or other cellular/gene therapies.
- Ongoing bacterial, viral or fungal infection requiring systemic anti-infectives.
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 |
|---|---|---|
| CHT101CD70 UCAR-T | Drug | CHT101 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 28 days of first infusion of CHT101
Safety
Maximum tolerated dose (MTD)
Time frame: 28 days of first infusion of CHT101
Tolerability
7 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Pharmacokinetics (PK)
Time frame: 2 years
Pharmacodynamics (PD)
Time frame: 2 years
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 6 Apr 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.
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 CHT101 in people with Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma (CTCL), run by Tianjin Medical University Cancer Institute and Hospital 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 12 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: looking for participants now, as of the sponsor's last update on 6 Apr 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?
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 Huilai Zhang (+86-18622221228, huilaizhangtz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: 28 days of first infusion of CHT101). 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 6 Apr 2025.