Status:
COMPLETED
A Study of CTA30X Cell Injection in Patients With Relapsed or Refractory CD19-positive B-line Hematological Malignancies
Lead Sponsor:
He Huang
Collaborating Sponsors:
Nanjing Bioheng Biotech Co., Ltd.
Conditions:
Acute Lymphoblastic Leukemia
Non-hodgkin Lymphoma
Eligibility:
All Genders
3-70 years
Phase:
EARLY_PHASE1
Brief Summary
A study of CTA30X cell injection in the treatment of relapsed or refractory CD19-positive B-line hematological malignancies
Detailed Description
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy: B-ALL and B-NHL. the selection of dose levels and the n...
Eligibility Criteria
Inclusion
- 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 Philadelphiachromosome-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 chemotherapy;
- Primary drug resistance;
- Recurrence after autologous hematopoietic stem cell transplantation
- Applicable standards for ALL and NHL:
- 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;
Exclusion
- 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).
- 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);
- If HBsAg positive at screening, HBV DNA copy number detected by PCR in patients with active hepatitis B \> 1000 (if HBV DNA copy number≤1000, routine antiviral therapy is required after enrollment), as well as CMV, hepatitis C, syphilis infection;
- 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.
Key Trial Info
Start Date :
December 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04689204
Start Date
December 29 2020
End Date
May 31 2024
Last Update
January 24 2025
Active Locations (1)
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1
The First Affiliated Hospital，College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003