SupCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
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 supCD7 CART cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase Ⅰ+Ⅱ clinical trial, two cohorts were set up: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory T-ALL/LBL cohort. Each cohort was planned to enroll 4-12 patients. SupCD7 CART cells will be administered intravenously to explore the 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;
Patients who have received anti-tumor therapy before infusion should be excluded if any of the following conditions are met: a. Systemic chemotherapy (except for pretreatment) within 1 week; b. For those who have received monoclonal antibody therapy, the last time of monoclonal antibody infusion is less than 5 half-lives or 4 weeks (whichever is shorter) at screening; c. Received donor lymphocyte infusion (DLI) within 6 weeks;
Trial design
Design model
Single group
Treatments tested in this trial
supCD7 CART cells
Biological/VaccineSubjects screened to meet the requirements for supCD7 CART cells use will enter clinical trials. Subjects were assessed at baseline. Fludarabine and cyclophosphamide based preconditioning should be performed within 1 week prior to supCD7 CART cells infusion: fludarabine (Flu) 30mg/m2 ×3 days; cyclophosphamide (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 VP-16. Infusion of supCD7 CART cells must be performed 24 hours after completion of chemotherapy preconditioning. supCD7 CART cells 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: The efficacy of supCD7 CART cell therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate (ORR)
1. The proportion of patients achieving CR (complete remission) or CRi (complete remission with incomplete hematologic recovery) for T-ALL/LBL. 2. The proportion of patients achieving CR, CRi, or PR (partial remission) for T-ALL/LBL. 3. The proportion of patients achieving CRc \[composite complete remission, including CR/CRh (complete remission with partial hematologic recovery)\] or CRi for AML.
Time frame
Efficacy will be evaluated at Weeks 4, 8, and 12 following supCD7 CART cell infusion.Secondary outcomes
1
Total MRD-negative response rate (MRD-ORR) in bone marrow after supCD7 CART cell infusion
The proportion of patients achieving CR/CRi (T-ALL/LBL) or CRc (AML) who are MRD-negative in the bone marrow.
Time frame
3 months after supCD7 CART cells infusion2
Duration of remission (DOR)
The time from first achieving CR/CRi + PR (T-ALL/LBL) or CRc + PR (AML) after supCD7 CAR-T infusion to disease relapse or death due to leukemia.
Time frame
Participants will be followed for the duration of the treatment, an expected average of 24 months3
Event-free survival (EFS)
The time from supCD7 CAR-T infusion to the earliest occurrence of any of the following events: death from any cause after remission, relapse, no response to treatment, or treatment discontinuation due to leukemia- and/or treatment-related death, adverse events, or initiation of new anti-tumor therapy (excluding bridging transplantation).
Time frame
Participants will be followed for the duration of the treatment, an expected average of 24 months.4
Leukemia-free survival (LFS)
The time from first achieving 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