A Study of CT-RD06 Cell Injection in Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancy

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Recruiting
participants needed

72
sponsor

He Huang

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Updated on 19 February 2024

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cancer

chemotherapy regimen

ejection fraction

chronic lymphocytic leukemia

lymphoid leukemia

hematologic malignancy

lymphoma

flow cytometry

oxygen saturation

cancer chemotherapy

oximetry

leukemia

diffuse large b-cell lymphoma

b-cell acute lymphoblastic leukemia

lymphoblastic leukemia

acute lymphoblastic leukemia

Summary

A study of CT-RD06 cell injection in patients with relapsed or refractory CD19+ B-cell hematological malignancy.

Description

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-cell hematological malignancy: B-ALL and B-NHL, the selections of dose levels and the number of subjects are based on clinical trials 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	CT-RD06
Clinical Study Identifier	NCT04226989
Sponsor	He Huang
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Inclusion criteria only for B-ALL
	Male or female aged 3-70 years
	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
	Ineffectively after first or multiple remedial treatments
	2 or more relapses
	The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is5% (by morphology), and/or1% (by 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 only for B-NHL
	Male or female aged 18-70 years
	Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016)
	Relapsed or refractory B-NHL (meeting one of the following conditions)
	No response or relapse after second-line or above chemotherapy regimens
	Primary drug resistance
	Relapse after auto-HSCT
	At least one assessable tumor lesion per Lugano 2014 criteria
	Common inclusion criteria for B-ALL and B-NHL
	Total bilirubin 51 umol/L, ALT and AST 3 times of upper limit of normal, creatinine 176.8 umol/L
	Echocardiogram shows left ventricular ejection fraction (LVEF) 50%
	No active infection in the lungs, blood oxygen saturation in indoor 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
	Inclusion exclusion criteria only for B-ALL
	Extramedullary lesions, except that CNSL (CNS-1) has been effectively controlled
	Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/ lymphoma per WHO Classification Criteria
	Hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
	Inclusion exclusion criteria only for B-NHL
	Extranodal lesions in the brain (tumor cells in CSF, and/or MRI shows invasion of intracranial lymphoma)
	Extensive invasion of gastrointestinal lymphoma
	Common exclusion criteria for B-ALL and B-NHL
	History of hypersensitivity to any component of cell product
	Prior treatment with any CAR T cell product or other genetically-modified T cell therapies
	Prior treatment with radiotherapy, chemotherapy or mAb 1 week prior to apheresis
	New York Heart Associate (NYHA) Class III/IV cardiac insufficiency (see Appendix 1)
	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
	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
	Autoimmune diseases requiring treatment, immunodeficiency or patients requiring immunosuppressive therapy
	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 and HIV 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
	Female pregnant or lactating, male for female fertile but unable to take medically acceptable contraception measures
	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 CT-RD06 Cell Injection in Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancy