A Phase 1 interventional study of CD7CAR T cells in Relapsed/Refractory, High Risk Hematologic Malignancies and T-ALL/Lymphoma, sponsored by iCell Gene Therapeutics. Status unknown at 1 site in China. Open to participants aged 2 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-07-06.
Sponsored by iCell Gene Therapeutics · Phase 1, Interventional, and Treatment
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD7 CAR-T cells in patients with relapsed and/or refractory, high risk hematologic malignancies.
T-acute lymphoblast leukemia (T-ALL) accounts for 15-20% of all ALL cases. It is a neoplastic lymphoid leukemia characterized by the proliferation of immature precursor T cells. T-ALL is a highly aggressive tumor. Adults need intensive chemotherapy, and the cure rate is \<50%, even with stem cell transplantation. The prognosis is also very poor. The combined chemotherapy has significantly improved the prognosis of T-acute lymphoblast leukemia/lymphoma. However, once the disease appears to be relapsed/refractory, there is limited treatment options, and the overall prognosis is extremely poor. Therefore, exploring safe and effective treatments is a critical unmet medical need. Since 95% of T-ALLs express CD7, this might provide an effective targeting approach for the vast majority of T-ALL cases.
4,347 studies on the registry are indexed under Recurrence; 1,004 are open to participants now.
This study's planned enrollment of 24 is below the median of 50 across 3,429 interventional studies indexed under Recurrence.
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Dose escalation phase: CD7 CAR T cells will be transduced with a lentiviral vector to express a CD7 CARs. with an escalation approach, 1 e6 to 7 e6 CAR-T cells/kg
Biological: CD7CAR T cells
CD7 CAR T cells are used to treat patients. Patient will be administered either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
The number and incidence of adverse events after CD7 CAR infusion.
Evaluation all possible adverse reactions, including the number, incidence, and severity of symptoms such as cytokine release syndromes and neurotoxicity within 3 months after CAR infusion
Time frame: Up to 3 months
Disease response to CD7 CAR T cells
The disease response to CD7 CAR T cells is evaluated by bone marrow biopsy and aspirate within 1 years after CAR infusion. The proportion of subjects receiving CD7 CAR T infusion to 1) morphological remission (blasts \<5%): 2) flow cytometry analysis was blast negative, and 3) molecular biological remission (if applicable).
Time frame: Up to 1 year
Evaluation of curative effects
Evaluation of curative effects within 1 year including 1)completion remission (CR), 2) complete remission with incomplete recovery of blood cells (CRi), 3) minimal residual disease positive (MRD+), 4)minimal residual disease negative (MRD-), and 4) disease recurrence or progression
Time frame: Up to 1 year
Overall survival
Overall survival {1 year after CAR infusion\] . The time from the start of CD7 CAR T injection to death is determined as the overall survival
Time frame: Up to 1 year
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Anti-CD7 CAR T-cells
iCell Gene Therapeutics