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T-cell Acute Lymphoblastic LeukemiaEarly Phase 1NCT04860817

A Study of Anti-CD7 CAR-T Cells in Pediatric and Young Adult Patients With Relapse and Refractory T-ALL/ T-LBL

A Early Phase 1 study testing Target CD7 CAR-T cells in people with T-cell Acute Lymphoblastic Leukemia and T-lymphoblastic Lymphoma, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

T cells are a type of immune cell. Like other cells of the body, T Cells can develop cancer. T cell cancers mainly include T cell leukaemia and T cell lymphoma, both of which have a relatively poor prognosis. Read more about this study

Who is it for?
Ages 2 to 25 years
What is being tested?
Target CD7 CAR-T cells
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
1 Dec 2021to 1 Nov 2023
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 2 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 2 to 25 years
  • Diagnosed with relapsed and refractory CD7 + T cell acute lymphocytic leukemia (T-ALL) or relapsed and refractory CD7 + T lymphoblastic lymphoma (T-LBL)
  • Quantifiable tumor burden
  • Eastern cooperative oncology group (ECOG) performance status of 0 to 1
  • Life expectancy ≥12 weeks
  • Adequate organ function defined as:
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  • Serum ALT/AST ≤2.5 ULN
  • Creatinine clearance (as estimated by Cockcroft Gault) ≥60 mL/min
  • PT and APTT≤1.5 ULN
  • Total bilirubin ≤1.5 ULN
  • Cardiac ejection fraction ≥45%
  • No clinically significant ECG findings
  • Baseline oxygen saturation >90% on room air
  • Recovered from acute toxic effects of prior chemotherapy ≥one week before entering this study
  • Agreement to use of medical-approved-contraception during the period of trial and in 1 year after cell transfusion therapy
  • Signed informed consent form

Who cannot join

  • Diagnosis of other malignancy (except non-melanoma and cervical carcinoma in situ, bladder cancer, breast cancer that have a disease-free survival of more than 5 years)
  • Severe mental disorders
  • History of hereditary diseases, including but not limited to: Fanconi anemia, Shut-Dai syndrome, Costman syndrome or any other known bone marrow failure syndrome
  • Grade 2-4 acute graft-versus-host disease (GVHD) (Glucksberg criteria) or extensive chronic GVHD (Seattle criteria)
  • Grade III-IV heart failure or myocardial infarction, angioplasty or stent placement, unstable angina pectoris, or other clinically prominent heart disease within one year before enrollment
  • History or presence of CNS disorder, including but not limited to: seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
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  • Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled
  • Severe allergies
  • History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
  • History or diagnosis of pulmonary fibrosis
  • Participation in other clinical trials ≤4 weeks prior to enrollment
  • Concomitant disease that require systemic steroids or other immune suppressive therapy during the study period in researcher's judgement
  • Patients who are contraindicated to cyclophosphamide, fludarabine
  • Allogeneic cell therapy (such as donor lymphocyte infusion, DLI) ≤6 weeks prior to enrollment
  • Poor adherence due to physical, family, social, geographic, and other factors, who cannot follow the research plan and follow-up plan
  • Pregnant and lactating women
  • Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

    Kunming, Yunnan, 650100 P.R.China

Other trials in China

About this study

Official title: Investigating the Safety and Efficacy of Anti-CD7 CAR-T Cell Immunotherapy in Patients With Relapse and Refractory T-cell Acute Lymphoblastic Leukemia or T Lymphoblastic Lymphoma

T cells are a type of immune cell. Like other cells of the body, T Cells can develop cancer. T cell cancers mainly include T cell leukaemia and T cell lymphoma, both of which have a relatively poor prognosis. Currently, patients with relapsed/refractory type (the name given to cancer that reappears or grows again after a period of no changes or signs of cancer) of this leukaemia or lymphoma have limited choices for treatment. CAR-T cells are immune cells that are engineered to target specific cell markers. For example, CAR-T cells targeting the marker CD19 have shown great effectiveness in the treatment of B cell tumors that carry this marker. Here investigators construct a new universal CAR-T design targeting CD7 which is found on the cells of relapsed/refractory type T cell leukaemia and lymphoma and hope to test its safety and efficiency in the treatment of relapsed/refractory type T cell leukaemia and lymphoma.

Read the detailed description

Who can participate? Patients diagnosed with relapsed/refractory T cell leukaemia or lymphoma. Both genders, aged 2-25 years old.

What does the study involve? Enrolled participants are randomly chosen to receive one of three different dose levels of CAR-T cells.

  1. Dose level one: 0.6×10^7 cells/kg;
  2. Dose level two: 1×10^7 cells/kg;
  3. Dose level three: 1.5×10^7 cells/kg. Before CAR-T infusion, all participants will receive a preconditioning therapy including several chemotherapy agents or other interventions that are required to help the effect of the CAR-T cells. After completion of preconditioning therapy, infusion of the CAR-T cells via a tube into the vein needs to start within 1 week. Participants will receive one infusion of CAR-T cells which will take between 15 and 30 mins. All participants will have a blood test before infusion and at 4, 7, 10 and 14 days following infusion to measure their response to the treatment and some further tests will be required in some participants.

What are the possible benefits and risks of participating? The universal CAR-T cells targeting CD7 may lead to durable disease control and long term survival. The main risks of participating include cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS).

Where is the study run from? Haematology department of 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China (China).

Being tested
Target CD7 CAR-T cells
Keywords
CAR-T, CD7, T-ALL/LBL
Medical subject headings
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.

  • Target CD7 CAR-T cellsBiological

    Enrolled participants are allocated to one of three different dose levels of target CD7 CAR-T cells. The infusion dose of CAR-T cells will start at low dose and then rise to higher dose after completion of low dose group.

    1. Dose level one: 0.6×10^7 cells/kg;
    2. Dose level two: 1×10^7 cells/kg;
    3. Dose level three: 1.5×10^7 cells/kg. Before CAR-T infusion, all participants will receive a preconditioning therapy suggested as: Fludarabine 30 mg/m^2×6d, Cyclophosphamide 300 mg/m^2×6d or Cyclophosphamide 600 mg/m^2×6d. After completion of preconditioning therapy, infusion of CAR-T cells needs to start within 1 week. Participants will receive one infusion of CAR-T cells which will take between 15 and 30 mins.
Study groups in NCT04860817
Study groupRoleWhat they receive
Target CD7 CAR-T cellsExperimentalThree dose levels will be evaluated. The CAR-T cells will be administered with Cytoxan and fludarabine.
Receives: Biological: Target CD7 CAR-T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with dose-limiting toxicity

    Dose-limiting toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0) at 4 weeks following target CD7 CAR-T cells infusion

    Measured: up to 4 weeks after target CD7 CAR-T cells infusion

Secondary outcomes (4)

  1. Overall response rate (ORR)

    ORR of patients, determined by National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology: Acute Lymphoblastic Leukemia (2016.V2) for T-ALL response rate and Lugano 2014 for T-LBL response rate.

    Measured: 4 weeks, 12 weeks, 24 weeks after target CD7 CAR-T cells infusion

  2. Progression-free survival (PFS)

    PFS determined from patient notes at 24 weeks following target CD7 CAR-T cells infusion.

    Measured: 24 weeks after target CD7 CAR-T cells infusion

  3. Overall survival (OS)

    OS determined from patient notes at 24 weeks.

    Measured: 24 weeks after target CD7 CAR-T cells infusion

  4. Duration of remission (DOR)

    DOR determined from patient notes at 24 weeks.

    Measured: 24 weeks after target CD7 CAR-T cells infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2021
  2. Study start1 Dec 2021 (estimated)
  3. Primary completion30 Apr 2023 (estimated)
  4. Study completion1 Nov 2023 (estimated)

Why it stopped: No proper participant is found.

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04860817
Sponsor's protocol ID
GUT03
Status last verified
Nov 2022
First submitted
22 Apr 2021
Last updated
29 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Target CD7 CAR-T cells in people with T-cell Acute Lymphoblastic Leukemia and T-lymphoblastic Lymphoma, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China 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 16 inclusion and 18 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 29 Nov 2022. 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?

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?

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?

Number of patients with dose-limiting toxicity (time frame: up to 4 weeks after target CD7 CAR-T cells infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04860817.

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 2022.

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