A Study of CD20/CD22 Targeted CAR T-cell Therapy for Relapsed or Refractory Lymphoid Malignancies

  • STATUS
    Recruiting
  • End date
    May 23, 2028
  • participants needed
    100
  • sponsor
    He Huang
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Updated on 19 February 2024
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Summary

A Study of CD20/CD22 Targeted CAR T-cell Therapy for Relapsed or Refractory Lymphoid Malignancies.

Description

Relapsed/refractory hematological malignancies has a short survival time and a high mortality rate. A number of clinical trials in China and at abroad have shown that CAR T-cells targeting CD19 have a high remission rate and limited adverse effects in the treatment of relapsed/refractory leukemia, which has great clinical application prospect. The New England Journal (NEJM) reported in 2010 and 2013 that the Carl June's team at the University of Pennsylvania used CAR T-cells against CD19 to treat B-cell malignancies successfully. On August 30, 2017, the US FDA first approved Novartis CAR T-cells for the treatment of acute lymphocytic leukemia. Our center has completed the treatment of 33 cases of acute lymphoblastic leukemia with CAR-T cells targeting CD19, with a complete remission rate of 90% and 10 cases of lymphoma treated with CAR T-cells. At present, the international clinical trials of CD20 / CD22 dual-target CAR T-cells in the treatment of relapsed/refractory lymphoid hematological malignancies have achieved impressive results, but the number of patients needs to be further verified.

Based on the results of prior studies and the lack of effective treatment options for relapsed/refractory hematological malignancies, we have applied for a clinical trial of CD20 / CD22 dual-target CAR T-cells to treat relapsed/refractory hematological malignancy.

This is a single arm, open-label, single-center study. Patients with CD20 and CD22-positive relapsed/refractory hematological malignancies have an estimated survival of 2 years. The purpose is to evaluate the safety and effectiveness of CD20 / CD22 dual-target CAR T-cell therapy through this clinical trial study, and to provide clinical basis and experience for CAR T-cell technology in the treatment of clinical malignant hematological diseases.

Details
Condition Relapsed and Refractory, Lymphoid Hematological Malignancies
Age 3-70 years
Treatment CD20/CD22 dual Targeted CAR T-cells
Clinical Study IdentifierNCT04283006
SponsorHe Huang
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Inclusion criteria applicable to ALL only
Male or female aged 3 and <70 years old
Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1)
Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions)
CR not achieved after standardized chemotherapy
CR achieved following the first induction, but CR duration is 12 months
Ineffective after first or multiple remedial treatments
2 or more recurrences
The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is >5% (morphology) and/or >1% (Flow cytometry)
Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome- positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments
Inclusion criteria applicable to NHL only
Male or female aged 18 and <70 years old
Histologically confirmed diagnosis per WHO Classification Criteria for Lymphocytic Tumors 2016, including DLBCL(NOS), follicular lymphoma, Chronic lymphoblastic leukemia/small lymphoblastic lymphoma transforms DLBCL, PMBCL and high grade B cell lymphoma
Relapsed or refractory DLBCL (meeting one of the following conditions)
No remission or recurrence after receiving second-line or above second-line chemotherapy
Primary drug resistance
Recurrence after autologous hematopoietic stem cell transplantation
According to Lugano 2014, there should be at least one evaluable tumor lesion
Applicable standards for ALL and NHL
HLA antibody(-) or HLA antibody(+) and HLA donor specific antibody(DSA)(-)
total bilirubin 51umol/L, ALT and AST 3 times of upper limit of normal, creatinine 176.8umol/L
Echocardiogram shows left ventricular ejection fraction (LVEF) 50%
No active infection in the lungs, blood oxygen saturation by sucking air is 92%
Estimated survival time 3 months
ECOG performance status 0 to 2
Patients or their legal guardians volunteer to participate in the study and sign the informed consent

Exclusion Criteria

patients with extramedullary lesions, except those with CNSL (CNS-1) under effective control (for ALL patients only)
Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/lymphoma per WHO Classification Criteria (for ALL patients only)
Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome (for ALL patients only)
Patients with intracranial extralateral lesions (cerebrospinal fluid tumor cells and/or intracranial lymphoma invasion shown by MRI) (for NHL patients only)
Extensive involvement of gastrointestinal lymphoma (for NHL patients only)
Radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening
Have a history of allergy to any of the components in the cell products
Prior treatment with any CAR T cell product or other genetically-modified T cell therapies
According to the New York heart association (NYHA) cardiac function classification criteria, Subjects with grade III or IV cardiac insufficiency
Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment
Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999)
Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past
History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases
Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis)
Indwelling catheters in vivo (e.g. percutaneous nephrostomy, Foley catheter, bile duct catheter, or pleural/peritoneal/pericardial catheter). Ommaya storage, dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are allowed
History of other primary cancer, except for the following conditions
Cured non-melanoma after resection, such as basal cell carcinoma of the skin
Cervical cancer in situ, localized prostate cancer, ductal cancer in situ with disease-free survival 2 years after adequate treatment
Patients with autoimmune diseases requiring treatment, patients with immunodeficiency or requiring immunosuppressive therapy
Patients with graft-versus-host disease (GVHD)
Prior immunizations with live vaccine 4 weeks prior to screening
History of alcoholism, drug abuse or mental illness
If HBsAg positive at screening, HBV DNA copy number detected by PCR in patients with active hepatitis B > 1000 (if HBV DNA copy number1000, routine antiviral therapy is required after enrollment), as well as CMV, hepatitis C, syphilis infection
Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids
Patients who have participated in any other clinical studies within 2 weeks prior to screening
Pregnant and breast-feeding women and the subjects who are fertile and unable to take effective contraceptive measures (regardless of the gender)
Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
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