uCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
The aim of this study was to evaluate the safety and efficacy of universal CD7 CART (uCD7 CART) cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase 1 clinical trial, two cohorts were set up: (1) relapsed and refractory acute myeloid leukemia (AML) cohort; and (2) relapsed and refractory T lymphoblastic leukemia/lymphoma (T-ALL/LBL) cohort. Each cohort was planned to enroll 4-12 patients. uCD7 CART cells will be administered intravenously to explore the maximum tolerated dose (MTD) of each cohort using a 3+3 dose escalation and rapid titration design.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 and <70 years, regardless of gender;
T-ALL/LBL was diagnosed according to the criteria of NCCN Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020.v1) and T-cell Lymphoma Clinical Practice Guidelines (2020.v1);
Patients diagnosed with AML with reference to the Guidelines for Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2018 Edition) issued by the Health Commission;
Cytology confirmed that the tumor cells were CD7 positive.
Disqualifiers
acute promyelocytic leukemia (APL);
Presence of a genetic syndrome such as Fanconi's anemia, Kostmann's syndrome, Shwachman syndrome or any other known syndrome of bone marrow failure;
Patients with uncontrolled active central nervous system leukemia (CNSL), i.e. cerebrospinal fluid grades CNS 2 and CNS 3;
Systemic chemotherapy (except for pretreatment) within 1 week;
Trial design
Design model
Single group
Treatments tested in this trial
uCD7 CART
Biological/VaccineSubjects screened to meet the requirements for uCD7 CART use will enter clinical trials. Subjects were assessed at baseline. Fludarabine (Flu) and cyclophosphamide (CTX) based preconditioning should be performed within 1 week prior to uCD7 CART infusion: Flu 30mg/m2 ×3 days; CTX 500mg/m2 ×3 days. The investigator can adjust the pretreatment regimen appropriately according to the condition of the subject, such as increasing the dose of CTX to 600mg/m2 ×3 days, increasing the application of cytarabine and etoposide. Infusion of uCD7 CART must be performed 24 hours after completion of chemotherapy preconditioning. uCD7 CART can be infused at D-1 if the requirement of 24 hours after completion of preconditioning is met.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: uCD7 CARTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicity（DLT） Any toxicity associated with uCD7 CAR-T cells, or life-threatening hematological or non-hematological toxicity.
Any toxicity associated with uCD7 CART cells, or life-threatening hematological or non-hematological toxicity.
Time frame
3 months after uCD7 CART cells infusion2
Number of adverse event of CD7 CART cells treatment
Time frame
Participants will be followed for the duration of the treatment, an expected average of 24 months.Secondary outcomes
1
Response rate in 3 months
Time frame
3 months after uCD7 CART cells infusion2
Duration of remission (DOR）
Time to first CR/CRi + PR (T-ALL/LBL) or CRc + PR (AML) to disease relapse or death due to leukemia after uCD7 CART infusion.
Time frame
Participants will be followed for the duration of the treatment, an expected average of 24 months.3
Event-free survival (EFS)
Time frame
Participants will be followed for the duration of the treatment, an expected average of 24 months.4
Leukemia-free Survival (LFS）
Time from first CR/CRi (ALL/LBL) or CRc (AML) to relapse or death.
Time frame
Participants will be followed for the duration of the treatment, an expected average of 24 months.Sponsors and contacts
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Source ClinicalTrials.gov