Metastatic TumorPhase 1NCT06383507
A Clinical Study of Anti-CD70 UCAR-T in Relapsed or Refractory Solid Tumors
A Phase 1 study testing CHT101 in people with Metastatic Tumor and Advanced Solid Tumor, run by Zhejiang University.
Trial summary
This is a single-center, single-arm ，open-label ，dose escalation and dose extension study. In this study we plan to evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive refractory or relapsed solid tumors, and obtain recommended doses and infusion patterns. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Tumor, Advanced Solid Tumor, Renal Cell Carcinoma
- What is being tested?
- CHT101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2024to 21 Apr 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and sign a written informed consent documen；
- Age ≥18 years old, male or female；
- Histopathological confirmed advanced or metastatic solid tumors failed to at least second-line treatment or initially diagnosed advanced/metastatic solid tumors that have no NCCN guideline recommended standard first-line therapy；
- Histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen) diagnosed as advanced/metastatic solid tumor (positive tumor CD70 expression (tumor CD70 positive (IHC 2+) confirmed by histology or pathology));
- At least one measurable lesion at baseline per RECIST version 1.1；
- The expected survival time is more than 12 weeks;
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- ECOG 0-1 points;
- The function of important organs is basically normal:Hematopoietic function:
- Hematopoietic function: neutrophils ≥ 1.5×109/L, platelets ≥ 90×109/L, hemoglobin ≥ 90g/dL;
- Renal function: serum creatinine≤1.5×ULN;
- WBC≥3.0×109/L,
- Liver function: Total bilirubin ≤ 1.5×ULN(Except Gilbert syndrome), extrahepatic metastasis：ALT and AST ≤ 3.0×ULN (Nonhepatic metastasis：it can be relaxed to ≤ 5.0×ULN);
- coagulation function：INR≤1.5×ULN，APTT≤1.5×ULN
- Subjects agree to use reliable and effective contraceptive methods for contraception within 6 months after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception);
Who cannot join
- Received anti-CD70 drug treatment before screening;
- Received anti-tumor therapy such as chemotherapy and targeted therapy within 2 weeks or at least 5 half-lives (whichever is longer) before Received;
- Received systemic corticosteroid therapy at doses greater than 10 mg/day prednisone (or equivalent doses of other corticosteroids) within 2 weeks prior to Received；
- Pregnant, lactating, or breastfeeding females;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA titer test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive; cytomegalovirus (CMV) DNA test positive;
- Have any of the following heart conditions:
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- New York Heart Association (NYHA) stage III or IV congestive heart failure; Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment; Clinically significant ventricular arrhythmia, echocardiography showed cardiac ejection fraction<50%,
- Active/symptomatic central nervous system metastases or meningeal metastases at the time of screening; subjects with brain metastases who have been treated must be confirmed to have no imaging evidence of progression ≥ 4 weeks after the end of treatment before they can be enrolled;
- Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation;
- Vaccination within 14 days of study enrollment;
- Received live attenuated vaccine within 4 weeks before screening;
- Malignant tumors other than the target tumor within 3 years prior to screening, except for the following: malignant tumors that have received radical treatment and no known active disease within ≥ 3 years prior to enrollment;
- Other investigators deem it inappropriate to participate in the study.
- Serious or uncontrollable systemic disease or any unstable systemic disease, including but not limited to uncontrolled hypertension, uncontrolled hyperglycemia, liver and kidney insufficiency or metabolic disease, central nervous system disease, etc
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-T in the Treatment of CD70-positive Refractory or Relapsed Solid Tumors
This is a single-center, single-arm ，open-label ，dose escalation and dose extension study. In this study we plan to evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive refractory or relapsed solid tumors, and obtain recommended doses and infusion patterns.
Read the detailed description
In the discovery phase, accelerated titration combined with the "3+3" dose escalation principle was adopted, starting from the initial dose of 3×106/kg. If a grade ≥3 AE occurs during DLT observation, the accelerated titration mode will switch to "3+3" dose escalation, at least 12 eligible patients will be enrolled and receive 4 doses of CD70 UCAR-T cell therapy (3 × 10^6 cells/kg, 6 × 10^6 cells/kg, 8× 10^6 cells/kg, 1 × 10^7 cells/kg).
In the dose expansion phase, each group will choose one or two dose groups to verify the safety and efficacy, and plan to recruit about 6 subjects in each dose group.
During the clinical study, after the completion of each dose group, the Safety Monitoring Committee (SMC) will determine whether it is possible to continue to increase to the next higher dose group, or add more subjects to the current dose group, or reduce to a lower dose group to continue to explore, or climb to a higher dose after reaching the highest dose (1 × 10^7 cells/kg).
Conditions Relapsed Tumor, Refractory Solid Tumor, Renal Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Nasopharyngeal carcinoma, Ovarian Cancer, Cervix Cancer etal
- Conditions
- Metastatic Tumor, Advanced Solid Tumor, Renal Cell Carcinoma, Ovarian Cancer, Cervix Cancer, Head and Neck Squamous Cell Carcinoma
- Being tested
- CHT101
- Medical subject headings
- Neoplasm Metastasis, Carcinoma, Renal Cell, Ovarian Neoplasms, Uterine Cervical Neoplasms, Squamous Cell Carcinoma of Head and Neck, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHT101Drug
After lymphodepletion with Fludarabine and Cyclophosphamide, CD70 UCAR T cells were transfused intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Anti-CD70 UCAR-T Cell Injection | Experimental | In the discovery phase, accelerated titration combined with the "3+3" dose escalation principle was adopted, starting from the initial dose of 3×106/kg. If a grade ≥3 AE occurs during DLT observation, the accelerated titration mode will switch to "3+3" dose escalation, at least 12 eligible patients will be enrolled and receive 4 doses of CD70 UCAR-T cell therapy (3 × 10^6 cells/kg, 6 × 10^6 cells/kg, 8× 10^6 cells/kg, 1 × 10^7 cells/kg).
In the dose expansion phase, each group will choose one or two dose groups to verify the safety and efficacy, and plan to recruit about 6 subjects in each dose group. Receives: Drug: CHT101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events after CD70 UCAR-T cells infusion (Safety and Tolerability)
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Measured: 28 days
Secondary outcomes (2)
Disease control rate (DCR)
The proportion of subjects who achieved CR, PR, SD after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.
Measured: 42 days
Objective response rate (ORR)
The proportion of subjects who achieved CR, PR after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start22 Apr 2024 (estimated)
- Primary completion21 Apr 2027 (estimated)
- Study completion21 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic TumorStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijia Fang, MD, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383507
- Sponsor's protocol ID
- CHT101
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 25 Apr 2024
- 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 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-T in the Treatment of CD70-positive Refractory or Relapsed Solid Tumors
- ClinicalTrials.gov ID
- NCT06383507
- Acronym / sponsor ID
- CHT101
- Conditions
- Metastatic Tumor, Advanced Solid Tumor, Renal Cell Carcinoma, Ovarian Cancer, Cervix Cancer, Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 22 Apr 2024 (estimated)
- Primary completion
- 21 Apr 2027 (estimated)
- Study completion
- 21 Apr 2029 (estimated)
- First posted
- 25 Apr 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.
This is a single-center, single-arm ，open-label ，dose escalation and dose extension study. In this study we plan to evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive refractory or relapsed solid tumors, and obtain recommended doses and infusion patterns.
Detailed description
In the discovery phase, accelerated titration combined with the "3+3" dose escalation principle was adopted, starting from the initial dose of 3×106/kg. If a grade ≥3 AE occurs during DLT observation, the accelerated titration mode will switch to "3+3" dose escalation, at least 12 eligible patients will be enrolled and receive 4 doses of CD70 UCAR-T cell therapy (3 × 10^6 cells/kg, 6 × 10^6 cells/kg, 8× 10^6 cells/kg, 1 × 10^7 cells/kg).
In the dose expansion phase, each group will choose one or two dose groups to verify the safety and efficacy, and plan to recruit about 6 subjects in each dose group.
During the clinical study, after the completion of each dose group, the Safety Monitoring Committee (SMC) will determine whether it is possible to continue to increase to the next higher dose group, or add more subjects to the current dose group, or reduce to a lower dose group to continue to explore, or climb to a higher dose after reaching the highest dose (1 × 10^7 cells/kg).
Conditions Relapsed Tumor, Refractory Solid Tumor, Renal Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Nasopharyngeal carcinoma, Ovarian Cancer, Cervix Cancer etal
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-CD70 UCAR-T Cell Injection | Experimental | Drug: CHT101In the discovery phase, accelerated titration combined with the "3+3" dose escalation principle was adopted, starting from the initial dose of 3×106/kg. If a grade ≥3 AE occurs during DLT observation, the accelerated titration mode will switch to "3+3" dose escalation, at least 12 eligible patients will be enrolled and receive 4 doses of CD70 UCAR-T cell therapy (3 × 10^6 cells/kg, 6 × 10^6 cells/kg, 8× 10^6 cells/kg, 1 × 10^7 cells/kg). In the dose expansion phase, each group will choose one or two dose groups to verify the safety and efficacy, and plan to recruit about 6 subjects in each dose group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ability to understand and sign a written informed consent documen；
- Age ≥18 years old, male or female；
- Histopathological confirmed advanced or metastatic solid tumors failed to at least second-line treatment or initially diagnosed advanced/metastatic solid tumors that have no NCCN guideline recommended standard first-line therapy；
- Histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen) diagnosed as advanced/metastatic solid tumor (positive tumor CD70 expression (tumor CD70 positive (IHC 2+) confirmed by histology or pathology));
- At least one measurable lesion at baseline per RECIST version 1.1；
Key exclusion criteria (14 listed)
- Received anti-CD70 drug treatment before screening;
- Received anti-tumor therapy such as chemotherapy and targeted therapy within 2 weeks or at least 5 half-lives (whichever is longer) before Received;
- Received systemic corticosteroid therapy at doses greater than 10 mg/day prednisone (or equivalent doses of other corticosteroids) within 2 weeks prior to Received；
- Pregnant, lactating, or breastfeeding females;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA titer test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive; cytomegalovirus (CMV) DNA test positive;
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 |
|---|---|---|
| CHT101After lymphodepletion with Fludarabine and Cyclophosphamide, CD70 UCAR T cells were transfused intravenously. | Drug | Anti-CD70 UCAR-T Cell Injection |
Primary outcome
Incidence of Adverse events after CD70 UCAR-T cells infusion (Safety and Tolerability)
Time frame: 28 days
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
2 secondary outcomes
Disease control rate (DCR)
Time frame: 42 days
Objective response rate (ORR)
Time frame: 42 days
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 25 Apr 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHT101 in people with Metastatic Tumor and Advanced Solid Tumor, run by Zhejiang University.
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 14 inclusion and 14 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 25 Apr 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 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 Weijia Fang, MD (691655, weijiafang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events after CD70 UCAR-T cells infusion (Safety and Tolerability) (time frame: 28 days). 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 25 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.