Donor-Derived CD5 CAR T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia

  • STATUS
    Recruiting
  • End date
    Sep 1, 2024
  • participants needed
    18
  • sponsor
    Beijing Boren Hospital
Updated on 16 May 2022

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 cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia. At least 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.

Details
Condition T-Cell Acute Lymphoblastic Leukemia
Treatment CD5 CART
Clinical Study IdentifierNCT05032599
SponsorBeijing Boren Hospital
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the
following criteria
Candidates with relapse or refractory CD5+ T cell acute lymphoblastic leukemia, who
have progressed on after treatment with all standard therapies or 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
to 2
Have life expectancy of at least 60 days based on investigator's judgement
CD5 positive in bone marrow or cerebrospinal fluid (CSF) by flow cytometry, or CD5
positive in tumor tissues by immunohistochemistry; (CD5 positive criteria: Flow
cytometry: Positive: > 80% of tumor cells expressed CD5 and the 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 1log; 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; subjects who
voluntarily participate in the study should have the ability to understand and sign
the informed consent form and be willing to follow the study visit schedule and
relevant study procedure, as specified in the protocol. Candidates aged 19-70 years
need to be sufficiently conscious and able to sign the treatment consent form and
voluntary consent form; Children candidates of 8-18 years old need to be sufficiently
conscious and able to sign the treatment consent form and voluntary consent form and
their legal guardian or patient advocate has also need to sign the treatment consent
form and voluntary consent form, respectively.Children candidates of 1-7 can be
recruited after the legal guardian or patient advocate has signed 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

Exclusion Criteria

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
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 who plan to receive new-donor derived CD5 CAR
T cells
No donor is applicable for peripheral blood mononuclear cell (PBMC) collection or no
frozen donor's PBMC is available for manufacturing CAR T cells
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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