CD180 CART for Relapsed or Refractory CD180 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 objective of this study was to evaluate the safety and efficacy of CD180 CART cells in the treatment of patients with relapsed/refractory CD180-positive hematological malignancies. In this single-arm, open-label, single-center, Phase I clinical trial, two cohorts were set up: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory B-ALL/LBL cohort. CD180 CART cells will be administered intravenously using a 3+3 dose escalation and rapid titration design, with CART dose groups of (1) 0.5×10\^6 CART cells/kg;(2)1×10\^6 CART cells/kg; and (3) 3×10\^6 CART cells/kg. Each cohort was planned to enroll 6-12 patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 and <70 years, regardless of gender;
B-ALL/LBL was diagnosed according to the criteria of NCCN Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020.v1) and B-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 CD180 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
CD180 CART
Biological/VaccineSubjects screened to meet the requirements for CD180 CART use will enter clinical trials. Subjects were assessed at baseline. Fludarabine and cyclophosphamide based preconditioning should be performed within 1 week prior to CD180 CART 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 CD180 CART must be performed 24 hours after completion of chemotherapy preconditioning. CD180 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: CD180 CARTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicity（DLT）
Any toxicity associated with CD180 CART cells, or life-threatening hematological or non-hematological toxicity.
Time frame
3 months after CD180 CART cells infusion2
Number of adverse event of CD180 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
within 3 months after CD180 CART cells infusion2
Duration of remission (DOR)
Time to first CR/CRi + PR (B-ALL/LBL) or CRc + PR (AML) to disease relapse or death due to leukemia after CD180 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