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AzTrials

Relapsed B Cell Acute Lymphoblastic Leukemia (ALL)Phase 1NCT04653493

CD19 Targeted CAR T Cell Therapy in Patients With Relapsed/ Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)

A Phase 1 study testing CD19 CAR engineered autologous T-cells, Cyclophosphamide and Fludarabine in people with Relapsed B Cell Acute Lymphoblastic Leukemia (ALL) and Refractory B Cell Acute Lymphoblastic Leukemia (ALL), run by Sabz Biomedicals at 2 sites in Iran.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-arm, open-label, phase I study (safety and dose escalation) of autologous Chimeric Antigen Receptor (CAR) T-cells targeting CD19 in patients with relapsed/refractory B cell acute lymphoblastic leukemia (ALL). Read more about this study

Who is it for?
Ages Up to 25 years
What is being tested?
CD19 CAR engineered autologous T-cells, Cyclophosphamide and Fludarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesIran
Study dates
Aug 2021to Aug 2024
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 Up to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • CD19+ ALL patients with any of the following:
  • Relapsed or Refractory CD19 positive B-cell acute lymphoblastic leukemia (R/R B-ALL) A. Primary refractory disease despite at least 2 cycles of an intensive chemotherapy regimen designed to induce remission B. Refractory disease despite salvage therapy C. 2nd or greater relapse D. Any relapse after allogeneic hematopoietic stem cell transplantation
  • Informed consent explained to and signed by patient/parents or legal guardian.
  • The Karnofsky (age ≥10 years)/Lansky (age <10 years) performance status score over 50 points.
  • Expected to survive for more than 3 months.
  • Patients with a history of prior allogeneic hematopoietic stem cell transplant (HSCT) must be at least 3 months from HSCT at the time of CD19 CAR-T cells infusion and also have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis.
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  • Important organ function is satisfied: Heart ultrasound indicates cardiac ejection fraction ≥ 50%, no obvious abnormality in ECG; Adequate pulmonary function defined as forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if the patient is unable to perform pulmonary function testing; creatinine clearance calculated by Cockcroft-Gault formula ≥ 50 ml/min/1.73m2; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age; Total Bilirubin ≤ 3 times the upper limit of normal for age.
  • Absolute lymphocyte count ≥ 0.5 x 10⁹/L.
  • Hemoglobin ≥ 8 g/dl (can be transfused).
  • Platelet count ≥ 20,000/μL (can be transfused).
  • Meets eligibility criteria to undergo autologous apheresis.

Who cannot join

  • Isolated extra-medullary disease relapse.
  • Active CNS involvement of ALL (CNS Grade 3 per National Comprehensive Cancer Network guidelines).
  • Severe, uncontrolled bacterial, fungal or viral infections (Active hepatitis B or C, history of HIV infection)
  • Pre-existing significant neurological disorder.
  • Active significant acute graft versus host disease (GVHD) or moderate/severe chronic GVHD requiring systemic steroids or other immunosuppressants within 4 weeks of enrolment.
  • Pregnant or lactating female.
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  • The patient did not agree to use effective contraception during the treatment period and for the following 1 year.
  • A history of other malignant tumors.
  • Receiving systemic steroids therapy exceeding the equivalent of 0.5 mg/ kg/day of methylprednisolone, in the 7 days prior to CAR T-cell infusion
  • Receiving systemic immunosuppressive therapy in the 14 days prior to CAR T-cell infusion
  • Receiving intrathecal chemotherapy in the 7 days prior to CAR T-cell infusion

Trial locations and contacts

2 sites in 1 country.

Tahereh Rostami, M.D contact

+9821-88004140

trostami@sina.tums.ac.ir

Naser Ahmadbeigi, PhD contact

+9821-82415103

n-ahmadbeigi@sina.tums.ac.ir

Iran2 sites

  • Gene therapy research center, Shariati hospital, Tehran university of medical sciences, Iran

    Tehran

    Naser Ahmadbeigi, Phd, +9821-82415103, n-ahmadbeigi@sina.tums.ac.ir

  • Research Institute for Oncology- Hematology and Cell Therapy (RIOHCT), Tehran University of Medical Sciences

    Tehran

    Tahereh Rostami, M.D, +982188004140, trostami@sina.tums.ac.ir

Other trials in Iran

About this study

Official title: Phase I Clinical Trial Evaluating Safety of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)

This is a single-arm, open-label, phase I study (safety and dose escalation) of autologous Chimeric Antigen Receptor (CAR) T-cells targeting CD19 in patients with relapsed/refractory B cell acute lymphoblastic leukemia (ALL).

Read the detailed description

In this single-center, open-label, nonrandomized, no control, prospective clinical trial, pediatric or adolescent/young adult patients with CD19+ relapsed or refractory B cell acute lymphoblastic leukemia (R/R B-ALL) will be enrolled.

Eligible patients will receive CAR T product intravenously as a single or split dose following pre-conditioning by a lymphodepleting chemotherapeutic regimen and will then enter a 30-day follow-up period to monitor adverse events using the NCI CTCAE (version 5.0).

Being tested
CD19 CAR engineered autologous T-cells, Cyclophosphamide, Fludarabine, Mesna
Keywords
CD19+ B-cell Acute Lymphoblastic Leukemia, CAR T cell, Relapsed/Refractory B cell acute lymphoblastic leukemia
Medical subject headings
Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD19 CAR engineered autologous T-cellsBiological

    Given IV

    Following preconditioning with lymphodepleting chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) T cells as a single or split dose (day 0, 1 and 2, CAR cells will be intravenously infused at the 10%, 30% and 60% ratio respectively). Dosing of CD19 CAR-T cells will follow a dose-escalation schema, with dose changes based on dose-limiting toxicities.

  • CyclophosphamideDrug

    Given IV

  • FludarabineDrug

    Given IV

  • MesnaDrug

    Given IV

Study groups in NCT04653493
Study groupRoleWhat they receive
CD19 CAR-T cellsExperimentalPediatric or adolescent/young adult patients with CD19+ relapsed or refractory B cell acute lymphoblastic leukemia (R/R B-ALL)
Receives: Biological: CD19 CAR engineered autologous T-cells; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna

What is being measured

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

  1. Maximum Tolerated Dose (MTD) and Dose-limiting Toxicities (DLT) of CD19 CAR-T cells

    Patients will be continually assessed for unexpected adverse events using the NCI CTCAE (version 5.0) or unexpected early mortality 30 days post-infusion.

    The primary objectives for the Phase I study portion are to determine the maximum tolerated dose (MTD) and characterize the safety profile and dose-limiting toxicities (DLTs) of treatment with CD19 CAR-T cells in pediatric, adolescent and young adult patient's ≤ 25 years of age, with relapsed/refractory CD19+ ALL.

    Measured: Within 30 days after the last dose of CD19 CAR-T cells

Secondary outcomes (1)

  1. Number of patients who achieve complete morphological remission

    Number of patients who achieve complete morphological remission (Complete Response (CR) or Complete Response with Incomplete count recovery (CRi) in the bone marrow)

    Measured: Within 30 days post CD19 CAR-T cells

Timeline

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

  1. First posted4 Dec 2020
  2. Study startAug 2021 (estimated)
  3. Primary completionAug 2024 (estimated)
  4. Study completionAug 2024 (estimated)

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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04653493
Sponsor's protocol ID
CD19 CAR T Cells for R/R ALL
Status last verified
Mar 2021
First submitted
22 Nov 2020
Last updated
19 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD19 CAR engineered autologous T-cells, Cyclophosphamide and Fludarabine in people with Relapsed B Cell Acute Lymphoblastic Leukemia (ALL) and Refractory B Cell Acute Lymphoblastic Leukemia (ALL), run by Sabz Biomedicals at 2 sites in Iran.

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 11 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Iran. 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?

Contact Tahereh Rostami, M.D (+9821-88004140, trostami@sina.tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) and Dose-limiting Toxicities (DLT) of CD19 CAR-T cells (time frame: Within 30 days after the last dose of CD19 CAR-T cells). 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 NCT04653493.

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 19 Mar 2021.

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