T-Cell Acute Lymphoblastic Leukemia/LymphomaPhase 1NCT05487495
Donor-Derived CD5 CAR T (CT125B) Cells for Relapsed or Refractory T- Cell Acute Lymphoblastic Leukemia/Lymphoma
A Phase 1 study testing CD5 CAR T (CT125B) in people with T-Cell Acute Lymphoblastic Leukemia/Lymphoma, run by Beijing Boren Hospital at 1 site in China.
Trial summary
This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T (CT125B) cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma. 9-18 subjects will be enrolled. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- T-Cell Acute Lymphoblastic Leukemia/Lymphoma
- What is being tested?
- CD5 CAR T (CT125B)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2022to 31 Dec 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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Candidates with relapsed or refractory CD5+ T cell acute lymphoblastic leukemia/lymphoma, who have progressed after treatment with all standard therapies or been intolerant of standard care, have limited prognosis with currently available therapies and had no available curative treatment options (such as SCT or chemotherapy)
- Male or female, aged 1-70 years
- No serious allergic constitution
- Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2
- Have life expectancy of at least 60 days based on investigator's judgement
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- CD5 positive on blasts in bone marrow or CSF by flow cytometry, or CD5 positive on tumor tissues by immunohistochemistry; (CD5 positive criteria: Flow cytometry: Positive: > 80% of tumor cells expressed CD5 and the mean fluorescence intensity (MFI) of CD5 is the same as that in normal T cells; Dim: > 80% of tumor cells expressed CD5, but the MFI of CD5 is lower than that in normal T cells as least as 1 log; Partial positive: 20-80% of tumor cells expressed CD5 and the MFI of CD5 is the same as that in normal T cells. Tumor tissue immunohistochemistry: Positive > 30% tumor cells expressed CD5)
- Provide a signed informed consent before any screening procedure. Patients who voluntarily participate in the study should have the ability to understand and sign the informed consent form (ICF) and be willing to follow the visit schedule and relevant study procedure, as specified in the protocol. Candidates aged 19-70 years old need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. Candidates of 8-18 years old need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form, besides, their legal guardian or patient advocate also need to sign the treatment consent form and voluntary consent form. Children candidates of 1-7 years old can be recruited after the legal guardian or patient advocate need to sign the treatment consent form and voluntary consent form.
- Have suitable and available allogeneic hematopoietic stem cell transplantation donor, and is willing to proceed to SCT if achieve CR.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Intracranial hypertension or disorder of consciousness
- Symptomatic heart failure or severe arrhythmia
- Symptoms of severe respiratory failure
- Complicated with other types of malignant tumors
- Diffuse intravascular coagulation
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- Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value
- Suffering from septicemia or other uncontrollable infections
- Patients with uncontrollable diabetes
- Severe mental disorders
- Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI)
- Have received organ transplantation (excluding bone marrow transplant)
- Reproductive-aged female patients with positive blood HCG test
- Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS or syphilis
- Post-CAR SCT is not feasible in patients
- No donor is applicable for peripheral blood mononuclear cell (PBMC) collection or no frozen donor's PBMC is available for manufacturing CAR T cells.
- Patients unable to discontinue nucleoside antiviral drugs that have a similar mechanism to ganciclovir
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-in-Human (FIH), Open-Label, Non-Randomized, Single-Arm Phase 1 Study to Evaluate the Safety and Tolerability of Donor-Derived CD5 CAR T (CT125B) Cells ForRelapsed or Refractory T-Cell Acute Lymphoblastic Leukemia/Lymphoma
This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T (CT125B) cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma. 9-18 subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days.
Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 2×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) /kg.
- Being tested
- CD5 CAR T (CT125B)
- Keywords
- CAR-T, Leukemia, acute lymphoblastic leukemia/lymphoma
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD5 CAR T (CT125B)Biological
Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| CD5 CAR T (CT125B) | Experimental | All patients who receive CD5 CAR T (CT125B) cell infusion. Receives: Biological: CD5 CAR T (CT125B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and type of dose-limiting toxicity (DLT)
DLT assessment according to the clinical study protocol.
Measured: 21 days post intravenous injection
Incidence and severity of adverse events (AE)
Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0.
Measured: 30 days post intravenous injection
Secondary outcomes (5)
Objective response rate (ORR)
Objective response rate (ORR) according to NCCN.
Measured: 30 days post infusion
Counts and persistence of CAR T cells
Blood samples for determination of persistence/counts of infused CAR T cells will be analysed.
Measured: 30 days post infusion
Incidence and grade of severe adverse events (SAEs)
Incidence and severity of severe adverse events as assessed by NCI-CTCAE 5.0.
Measured: 2 years post infusion
Best overall response (BOR) rate
Best overall response (BOR) rate according to NCCN.
Measured: 3 months post infusion
The counts of CART cells after using CAR T suicidal switch drugs .
The counts of CART cells change when CAR T suicidal switch drugs ( ganciclovir ) are used for 3 days and 7 days respectively.
Measured: 7 days post administration of ganciclovir
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start3 Aug 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: ethic commitee decisiong
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-Cell Acute Lymphoblastic Leukemia/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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Boren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Pan, MD/PhD, Principal investigator, Beijing Gaobo Boren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487495
- Sponsor's protocol ID
- BRYY-IIT-LCYJ-2022-026
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human (FIH), Open-Label, Non-Randomized, Single-Arm Phase 1 Study to Evaluate the Safety and Tolerability of Donor-Derived CD5 CAR T (CT125B) Cells ForRelapsed or Refractory T-Cell Acute Lymphoblastic Leukemia/Lymphoma
- ClinicalTrials.gov ID
- NCT05487495
- Acronym / sponsor ID
- BRYY-IIT-LCYJ-2022-026
- Keywords
- CAR-T, Leukemia, acute lymphoblastic leukemia/lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: ethic commitee decisiong
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beijing Boren HospitalUniversity, hospital or other
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Aug 2022 (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 FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T (CT125B) cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma. 9-18 subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days.
Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 2×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) /kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD5 CAR T (CT125B) | Experimental | Biological: CD5 CAR T (CT125B)All patients who receive CD5 CAR T (CT125B) cell infusion. |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Candidates with relapsed or refractory CD5+ T cell acute lymphoblastic leukemia/lymphoma, who have progressed after treatment with all standard therapies or been intolerant of standard care, have limited prognosis with currently available therapies and had no available curative treatment options (such as SCT or chemotherapy)
- Male or female, aged 1-70 years
- No serious allergic constitution
- Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2
Key exclusion criteria (17 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Intracranial hypertension or disorder of consciousness
- Symptomatic heart failure or severe arrhythmia
- Symptoms of severe respiratory failure
- Complicated with other types of malignant tumors
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 |
|---|---|---|
| CD5 CAR T (CT125B)Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days. | Biological | CD5 CAR T (CT125B) |
Primary outcome
Incidence and type of dose-limiting toxicity (DLT)
Time frame: 21 days post intravenous injection
DLT assessment according to the clinical study protocol.
Incidence and severity of adverse events (AE)
Time frame: 30 days post intravenous injection
Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0.
5 secondary outcomes
Objective response rate (ORR)
Time frame: 30 days post infusion
Counts and persistence of CAR T cells
Time frame: 30 days post infusion
Incidence and grade of severe adverse events (SAEs)
Time frame: 2 years post infusion
Best overall response (BOR) rate
Time frame: 3 months post infusion
The counts of CART cells after using CAR T suicidal switch drugs .
Time frame: 7 days post administration of ganciclovir
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 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. This study is not recruiting at the moment.
Jing Pan, MD/PhD principal investigator
Beijing Gaobo Boren 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 CD5 CAR T (CT125B) in people with T-Cell Acute Lymphoblastic Leukemia/Lymphoma, run by Beijing Boren 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 9 inclusion and 17 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: withdrawn, as of the sponsor's last update on 14 Nov 2024. 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 withdrawn before enrolling participants, so there are no results.
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?
Incidence and type of dose-limiting toxicity (DLT) (time frame: 21 days post intravenous injection). 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 14 Nov 2024; AzTrials last refreshed its copy on 1 Nov 2026.