Donor-Derived CD5 CAR T (CT125B) Cells for Relapsed or Refractory T- Cell Acute Lymphoblastic Leukemia/Lymphoma

  • STATUS
    Recruiting
  • End date
    Jul 27, 2024
  • participants needed
    18
  • sponsor
    Beijing Boren Hospital
Updated on 4 October 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 (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.

Details
Condition T-Cell Acute Lymphoblastic Leukemia/Lymphoma
Treatment CD5 CAR T (CT125B)
Clinical Study IdentifierNCT05487495
SponsorBeijing Boren Hospital
Last Modified on4 October 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 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
to 2
Have life expectancy of at least 60 days based on investigator's judgement
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

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
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
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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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