Peripheral T Cell LymphomaPhase 1NCT04828174
Anti-TRBC1 CAR-T Cell Therapy in Patients With TRBC1 Positive T Cell Malignancies
A Phase 1 study testing anti-TRBC1 CAR-T cell therapy in people with Peripheral T Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment targeting TRBC1 in patients with relapsed or refractory TRBC1 positive T-cell hematological maliganacies Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral T Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Anaplastic Lymphoma
- What is being tested?
- anti-TRBC1 CAR-T cell therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2021to 26 Nov 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1)18 to 70 Years Old, Male and female; (2) Expected survival > 12 weeks; (3) ECOG score 0-2; (4) Confirmed diagnosis of acute T cell leukemia and screened for TRBC1 positive, including following conditions:
- Patients who do not get a CR with ≥2 prior lines of therapy
- Those who achieves CR, but have a early relapse(<12months),or a late relapse (>=12months) failing to acheive a CR after 1 line salvage chemotherapy
- For any Patiens failed ASCT/allo-SCT (5) Relapsed and refractory patients with diagnosis of T cell lymphoma have had≥2 prior lines of therapy,including:
- Peripheral T cell lymphoma NOS, or b. Angioimmunoblastic T cell lymphoma, or c. Anaplastic large cell lymphoma (6) Confirmed T lymphoblatic lymphoma
- Patients who do not get a CR with ≥2 prior lines of therapy
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- Relapsed patients failing to acheive a CR after 1 line salvage chemotherapy
- For any Patiens failed ASCT/allo-SCT (7) The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators; (8) Liver, kidney and cardiopulmonary functions meet the following requirements:
- Ccr≥60mL/min(Cockcroft Gault) b. Left ventricular ejection fraction >50%; c. Baseline oxygen saturation>92%; d. Total bilirubin ≤ 1.5×ULN; e. ALT and AST ≤ 3×ULN; (9) Able to understand and sign the In
Who cannot join
- Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
- Uncontrolled infection;patients with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 10^2 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA positive; syphilis positive;
- Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
- Any uncontrolled disease may affect entry
- Current or history of CNS involvement by malignancy.Known history or presence of clinically relevant central nervous system (CNS) pathology. Patients with a known history or prior diagnosis other immunologic or inflammatory disease affecting the CNS (such as epilepsy)
- Patients who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
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- Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pr egnancy within 1 year after cell transfusion;
- Active or uncontrollable infection requiring systemic therapy
- Received CAR-T treatment or other gene therapies before enrollment;
- Kown be allergic to anti-TRBC1 CAR-T cells or drugs(Fludarabine or Cyclophophamide)
- The investigators consider other conditions unsuitable for enrollment.
- Patients who may not be able to sign the Informed Consent due to disease,or who do not understand or unwillingness or inability to comply with research requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Clinical Efficacy of Human TRBC1 CAR-T Cell Therapy for Patients With Relapsed/Refractory TRBC1 Positive T Cell Hematological Maliganacies
The purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment targeting TRBC1 in patients with relapsed or refractory TRBC1 positive T-cell hematological maliganacies
- Conditions
- Peripheral T Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Anaplastic Lymphoma, Acute T Cell Leukemia, T-lymphoblastic Lymphoma
- Being tested
- anti-TRBC1 CAR-T cell therapy
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Immunoblastic Lymphadenopathy, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-TRBC1 CAR-T cell therapyDrug
TRBC1 positve patients with relapsed or refractory T cell malignacy will receive CAR-T cell therapy targetting TRBC1
| Study group | Role | What they receive |
|---|---|---|
| anti-TRBC1 CAR-T cell | Experimental | Administration with anti-TRBC1 CAR-T cells in the relapsed/refractory T cell hematological malignancy patients. Receives: Drug: anti-TRBC1 CAR-T cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Safety measured by occurence of study related adverse effects defined by NCI CTCAE5.0
Measured: 28 days post infusion
Secondary outcomes (5)
CAR-T cell expansion and persistence
To evaluate anti-TRBC1 CAR-T cell expansion and persistence after infusion
Measured: 2 years post infusion
Total response rate (ORR) after administration
CR+CRi for T-ALL CR+PR for T cell lyphoma
Measured: 3 months post infusion
Duration of remission (DOR) after administration
Duration of remission (DOR) after administration
Measured: 2 years post infusion
Overall Survival (OS)after administration
Overall Survival (OS)after administration
Measured: 2 years post infusion
Progression Free Survival (PFS) after infusion
Progression Free Survival (PFS) after infusion
Measured: 2 years after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start31 Mar 2021
- Primary completion26 Nov 2023 (estimated)
- Study completion26 Nov 2023 (estimated)
Why it stopped: The trial was suspended due to the inability to enroll qualified participants
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.
- 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
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828174
- Sponsor's protocol ID
- SHYSXY-202101-CART
- Status last verified
- Nov 2023
- First submitted
- 31 Mar 2021
- Last updated
- 29 Nov 2023
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Clinical Efficacy of Human TRBC1 CAR-T Cell Therapy for Patients With Relapsed/Refractory TRBC1 Positive T Cell Hematological Maliganacies
- ClinicalTrials.gov ID
- NCT04828174
- Acronym / sponsor ID
- SHYSXY-202101-CART
- Conditions
- Peripheral T Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Anaplastic Lymphoma, Acute T Cell Leukemia, T-lymphoblastic Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The trial was suspended due to the inability to enroll qualified participants
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 26 Nov 2023 (estimated)
- Study completion
- 26 Nov 2023 (estimated)
- First posted
- 1 Apr 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 purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment targeting TRBC1 in patients with relapsed or refractory TRBC1 positive T-cell hematological maliganacies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-TRBC1 CAR-T cell | Experimental | Drug: anti-TRBC1 CAR-T cell therapyAdministration with anti-TRBC1 CAR-T cells in the relapsed/refractory T cell hematological malignancy patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- (1)18 to 70 Years Old, Male and female; (2) Expected survival > 12 weeks; (3) ECOG score 0-2; (4) Confirmed diagnosis of acute T cell leukemia and screened for TRBC1 positive, including following conditions:
- Patients who do not get a CR with ≥2 prior lines of therapy
- Those who achieves CR, but have a early relapse(<12months),or a late relapse (>=12months) failing to acheive a CR after 1 line salvage chemotherapy
- For any Patiens failed ASCT/allo-SCT (5) Relapsed and refractory patients with diagnosis of T cell lymphoma have had≥2 prior lines of therapy,including:
- Peripheral T cell lymphoma NOS, or b. Angioimmunoblastic T cell lymphoma, or c. Anaplastic large cell lymphoma (6) Confirmed T lymphoblatic lymphoma
Key exclusion criteria (12 listed)
- Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
- Uncontrolled infection;patients with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 10^2 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA positive; syphilis positive;
- Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
- Any uncontrolled disease may affect entry
- Current or history of CNS involvement by malignancy.Known history or presence of clinically relevant central nervous system (CNS) pathology. Patients with a known history or prior diagnosis other immunologic or inflammatory disease affecting the CNS (such as epilepsy)
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 |
|---|---|---|
| anti-TRBC1 CAR-T cell therapyTRBC1 positve patients with relapsed or refractory T cell malignacy will receive CAR-T cell therapy targetting TRBC1 | Drug | anti-TRBC1 CAR-T cell |
Primary outcome
Safety and Tolerability
Time frame: 28 days post infusion
Safety measured by occurence of study related adverse effects defined by NCI CTCAE5.0
5 secondary outcomes
CAR-T cell expansion and persistence
Time frame: 2 years post infusion
Total response rate (ORR) after administration
Time frame: 3 months post infusion
Duration of remission (DOR) after administration
Time frame: 2 years post infusion
Overall Survival (OS)after administration
Time frame: 2 years post infusion
Progression Free Survival (PFS) after infusion
Time frame: 2 years after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 anti-TRBC1 CAR-T cell therapy in people with Peripheral T Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 12 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: paused, as of the sponsor's last update on 29 Nov 2023. 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?
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?
Safety and Tolerability (time frame: 28 days post infusion). 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 29 Nov 2023.