A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy

STATUS

Recruiting
End date

May 31, 2027
participants needed

72
sponsor

He Huang

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Updated on 19 February 2024

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cancer

remission

ejection fraction

chronic lymphocytic leukemia

lymphoid leukemia

cell transplantation

hematologic malignancy

lymphoma

flow cytometry

oxygen saturation

oximetry

leukemia

b-cell lymphoma

follicular lymphoma

diffuse large b-cell lymphoma

lymphoblastic lymphoma

b-cell acute lymphoblastic leukemia

lymphoblastic leukemia

autologous hematopoietic stem cell transplant

acute lymphoblastic leukemia

Summary

A study of CTA101 UCAR-T cell injection in patients with relapsed or refractory CD19+ B-line hematological malignancy

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 number of subjects are based on clinical tiral of similar foreign products. 2 groups of patients will be enrolled, 36 in each group. Primary objective is to explore the safety, main consideration is dose-related safety.

Details

Condition	childhood ALL, Lymphoma, Lymphoma
Age	3years - 70years
Treatment	CTA101
Clinical Study Identifier	NCT04227015
Sponsor	He Huang
Last Modified on	19 February 2024

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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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A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy