A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy
Recruiting now · Early Phase 1
Conditions studied: Acute Lymphoblastic Leukemia, Non-hodgkin Lymphoma
In brief
A study of CTA101 UCAR-T cell injection in patients with relapsed or refractory CD19+ B-line hematological malignancy
Key facts
- Study ID
- NCT04227015
- Run by
- He Huang
- People needed
- 72
- Starts
- 2020-01-08
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2020-12-28
Who can join
Age: 3 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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 number≤1000, 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;
Where it is running
- The First Hospital of Zhejiang Medical Colleage Zhejiang University — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.