BridgeMD
New treatment option for Acute Lymphoblastic Leukemia
Official title A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy
ClinicalTrials.gov ID: NCT04227015
What this study is testing
What is CTA101?
CTA101 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute lymphoblastic leukemia.
Also referred to as CTA101 UCAR-T cell injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A study of CTA101 UCAR-T cell injection in patients with relapsed or refractory CD19+ B-line hematological malignancy
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 70
You may be able to join if
- 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...
- Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
- CR not achieved after standardized chemotherapy;
You likely can't join 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 with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome (for...
- patients with intracranial extralateral lesions (cerebrospinal fluid tumor cells and/or intracranial lymphoma invasion shown by MRI) (for NHL...
- extensive involvement of gastrointestinal lymphoma (for NHL patients only);
- radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening;
See the full eligibility criteria
Who can join
- 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; 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...
- 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.
What rules you out
- 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, people 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...
- 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...
- 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.