UCAR-T for CD19+ Refractory/Relapsed B Hematologic Malignancies

NCT05015972 | Withdrawn Early Phase 1

• 1 other identifier: CTA30X
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, open-label, single-center prospective study to determinethe safety and efficacy of CTA30X UCAR-T cells in patients diagnosed with CD19+ refractory/relapsed B Hematologic Malignancies

Conditions

B-cell Lymphoma

Keywords

UCAR-T; allogeneic; CD19; B-ALL; B-NHL

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity

  CRS lasting ≥7 days G3 or ≥G4 after CTA30X infusion;

  Up to 24 weeks after CAR-T infusion

• Incidence of AE after CAR-T infusion

  Incidence of adverse events after CTA30X UCAR-T infusion

  Up to 4 weeks after the infusion of CAR-T cells

Secondary Outcomes (7)

• ORR rate

  1month, 3months after CTA30X UCAR-T infusion

• MRD-ORR

  within 3months after CTA30X UCAR-T infusion

• BOR

  within 3months after CTA30X UCAR-T infusion

• DOR

  From the onset of a tumor from the first assessment of CR or PR up to 1 year

• ORR

  6month, 12months、 18months and24months after CTA30X UCAR-T infusion

Other Outcomes (1)

• exploratory

  up to 24 months after CAR-T infusion

Study Arms (1)

CTA30X UCAR-T treatment

EXPERIMENTAL

CD19+ R/R B Hematologic Malignancies patients be treated with a single dose of CTA30X UCAR-T cells. Total dose of(5-30)\*10E6/kg cells will be administered at Day 0

Biological: CTA30X UCAR-T injection

Interventions

CTA30X UCAR-T injection BIOLOGICAL

CTA30X UCAR-T injection is an allogeneic CAR-Ttargeted CD19 . A single infusion of CART cells will be administered intravenously.

CTA30X UCAR-T treatment

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥3 and \< 70 years old, gender is not limited;
• Patients with a histologic diagnosis of CD19+ B-ALL according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
• Meet the R/R CD19+ B-ALL diagnosis, including any of the following conditions:
• A) No CR after standard chemotherapy; B) CR was induced for the first time, but the duration of CR was less than 12 months; C) R/R CD19+ B-ALL that failed after the first or repeated remedial therapy; D) 2 or more recurrences;
• Number of primary cells (primary + juvenile) in bone marrow, \> 5% (morphology) and/or \> 1% (flow cytometry);
• Philadelphia chromosomal negative (PH -) subjects;Philadelphia chromosomal positive (pH +) subjects who either cannot tolerate or do not respond to either of the TKI treatments;
• Age ≥18 years old and \< 70 years old, regardless of gender;
• According to the 2016 WHO classification criteria for lymphocytic tumors, the histological diagnosis included: DLBCL (NOS);Subjects with follicular lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma transformation, and PMBCL and high-grade B-cell lymphoma;
• Relapsed or refractory B-NHL (meets one of the following conditions) :
• A) Subjects have no remission or recurrence after receiving second-line chemotherapy regimen or above; B) primary drug resistance; C) Subjects relapse after autologous hematopoietic stem cell transplantation;
• According to Lugano 2014 criteria, there should be at least one evaluable tumor focus;
• Common standards for ALL and NHL:
• Serum total bilirubin ≤51 umol/L, serum ALT and AST ≤ 3 times of the upper limit of the normal range, serum creatinine ≤176.8 umol /L;
• Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
• Subjects have no active pulmonary infection, and oxygen saturation of suction finger vein is ≥92%;

You may not qualify if:

• Extramedullary lesions, except those with effectively controlled CNSL (CNS-1);(All patients only)
• A lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/lymphoma, was diagnosed according to WHO classification;(All patients only)
• having a genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome;(All patients only)
• Extranodal intracranial lesions (tumor cells in CSF and/or intracranial lymphoma shown on MRI);(For patients with NHL only)
• subjects with extensive gastrointestinal lymphoma invasion;(For patients with NHL only)
• Subjects received radiotherapy, chemotherapy and monoclonal antibody treatment within 1 week before screening;
• Have a history of allergy to any one ingredient in cell products;
• Prior use of any CAR T cell product or other genetically modified T cell therapy
• Subjects with cardiac dysfunction grade III or IV according to the New York Heart Association (NYHA) cardiac function classification standards;
• Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris or other clinically serious heart disease within 12 months of enrollment;
• Severe primary or secondary hypertension of grade 3 or higher (WHO Hypertension Guidelines, 1999);
• Patients with prolonged QT interval indicated by ECG and previous severe heart disease such as severe arrhythmia;
• Previous history of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.
• Severe active infection (except simple urinary tract infection and bacterial pharyngitis);
• Subject has a history of other primary cancers except for:

Sponsors & Collaborators

• 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China: lead
• Nanjing Bioheng Biotech Co., Ltd.: collaborator

Study Sites (1)

No.212 Daguan Road, Xishan District

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: August 23, 2021
• Study Start: August 20, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

CN (1)