RecruitingPhase 1Phase 2NCT05827835

CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases

A Study to Evaluate the Efficacy and Safety of CD7CAR-T Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed CD7 Positive Malignant Hematologic Diseases

Sponsor

Zhejiang University

Enrollment

30 participants

Start Date

Apr 30, 2023

Study Type

INTERVENTIONAL

Conditions

Neoplasms Hematologic Diseases

Summary

This is a single-arm, open-label, single-center, phase I/II study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases

Eligibility

Min Age: 18 Years

Inclusion Criteria18

Provision of signed and dated informed consent form (ICF)
Male or female, older than 18 years (including 18 years)
Anticipated survival time more than 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia and Acute Myeloid Leukemia (2016. v1), patients diagnosed as CD7+ALL and AML
Consistent with r/r CD7+acute leukemia diagnosis, including any of the following conditions
a. No CR after standard chemotherapy
b. The first induction reaches CR, but CR ≤ 12 months
c. Patients with r/r CD7+acute leukemia have not responded to the first or multiple remedial treatments
d. Multiple recurrences
Philadelphia chromosome negative (Ph -) subjects; Or cannot tolerate tyrosine kinase inhibitor (TKI) treatment; Or Philadelphia chromosome positive (Ph+) subjects who did not respond to both TKI treatments
Normal lung function, oxygen saturation greater than 92% without oxygen inhalation
The blood biochemical test results are consistent with the following results
a. (AST) and (ALT) ≤ 2.5 × (ULN)
b. Total bilirubin ≤ 1.5 × ULN
c. 24-hour serum creatinine clearance ≥ 30 mL/min
d. Lipase and amylase ≤ 2 × ULN
Fertility capable men and women of childbearing age must agree to use effective contraception starting with the signing of an informed consent form until within 2 years after the use of the study drug. Women of reproductive age include pre menopausal women and women within 2 years after menopause. The blood pregnancy test for women of reproductive age must be negative at screening

Exclusion Criteria13

Patients with the history of epilepsy or other CNS disease
Pregnant or breastfeeding
Active infection with no cure
Patients with prolonged QT interval time or severe heart disease
Have experienced hypersensitivity or intolerance to any drug used in this study
Patients who received anticancer chemotherapy or other drug treatment within 2 weeks before screening
Previous malignant tumors that require treatment or have evidence of recurrence within the previous 5 years of screening
Clinically significant central nervous system lesions such as seizures, cerebral vascular ischemia/hemorrhage, dementia, cerebellar disease, psychosis, active central nervous system involvement, or cancerous meningitis
In the past 2 years, terminal organ damage caused by autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or the need for systematic application of immunosuppressive or other systemic disease control drugs
Severe active viral, bacterial, or uncontrolled systemic fungal infections; Genetic bleeding/coagulation disorders, a history of non-traumatic bleeding or thromboembolism, and other diseases that may increase the risk of bleeding
Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during this study
Participated in clinical trials of other drugs within 4 weeks or 5 drug half-lives (T1/2) before screening
Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

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Interventions

DRUGCD7 CAR-T cells injection

CD7 CAR T cells treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases

OTHERAllogeneic hematopoietic stem cell transplantation

In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases