ThisCART19A for B-NHL Relapsed After Auto-CAR T

NCT05691153 | Unknown Phase 1

• 1 other identifier: SZ5602
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A (allogeneic CAR-T targeting CD19) in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma.

Conditions

CAR; B Cell Lymphoma; Relapsed Non-Hodgkin Lymphoma

Keywords

Universal CAR-T

Outcome Measures

Primary Outcomes (1)

• BOR

  Best Overall Response Rate

  3 month

Secondary Outcomes (7)

• ORR

  2 year

• CR

  2 year

• TTR

  3 month

• DOR

  2 year

• EFS

  2 year

Study Arms (2)

Dose Level 1

EXPERIMENTAL

ThisCART19A，2×10\^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused）

Drug: ThisCART19A with Dose Level 1

Dose Level 2

EXPERIMENTAL

ThisCART19A，3×10\^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused）

Drug: ThisCART19A with Dose Level 2

Interventions

ThisCART19A with Dose Level 1 DRUG

ThisCART19A，2×10\^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused）, after the lymphodepletion conditioning of fludarabine, CTX and VP-16

Also known as: ThisCART19A with 2×10^6 cells/kg

Dose Level 1

ThisCART19A with Dose Level 2 DRUG

ThisCART19A，3×10\^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused）, after the lymphodepletion conditioning of fludarabine, CTX and VP-16

Also known as: ThisCART19A with 3×10^6 cells/kg

Dose Level 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign a documented IRB-approved ICF prior to any screening procedure;
• Gender not restricted, 18 years ≤ age ≤ 75 years;
• Subjects with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma;
• Life expectancy ≥ 12 weeks at the time of enrollment;
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• At least one measurable lesion to be assessed, with any nodal lesion \> 15mm in LDi (longest diameter) and any extranodal lesion \> 10mm in LDi;
• Subject has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:
• Adequate marrow function for lymphodepletion chemotherapy: 14 days before enrollment, absolute neutrophil count (ANC) ≥ 1×10\^9/L, platelet count ≥ 30×10\^9/L, hemoglobin ≥ 80 g/L without blood transfusion;
• Creatinine clearance ≥ 30 ml/min according to the Cockcroft-Gault formula, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × the upper limit of normal (ULN), total bilirubin ≤ 2×ULN (Subjects with Gilbert syndrome or liver involvement may be enrolled if their total bilirubin is ≤ 3×ULN);
• Pulmonary function: Baseline oxygen saturation (SaO2) ≥ 92% on room air;
• Cardiac function：left ventricular ejection fraction (LVEF) ≥ 40% assessed by echocardiography.
• CD19-positive lymphoma confirmed on a biopsy during screening.

You may not qualify if:

• Allergic to preconditioning measures in the trial.
• Other malignancies apart from B-cell malignancies within 5 years prior to screening. (Subjects with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited.)
• Severe active infection (Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted).
• Pulmonary embolism (PE) within 3 months prior to enrollment.
• Intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases assessed by the investigator prior to enrollment.
• Gastrointestinal involvement at risk of active bleeding.
• Massive pericardial effusion, symptomatic thoracic or abdominal effusion.
• Presence of CNS involvement (both primary and secondary) at screening confirmed by imaging or CSF testing.
• Active hepatitis B virus (serum HBV-DNA ≥ 2000 IU/mL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment. (Patients with HBV-DNA \< 2000 IU/mL can be enrolled, but should be administered antiviral drugs such as entecavir and tenofovir with relative clinical indicators monitored simultaneously during the treatment.)
• Less than 100 days after allogeneic hematopoietic stem cell transplantation.
• Vaccinated with influenza vaccine within 2 weeks prior to lymphodepletion chemotherapy. (Patients vaccinated with SARS-COV19 vaccine or inactivated; live/non-live adjuvant vaccines can be enrolled.)
• Under treatment for graft versus host disease (GvHD). (GvHD cured subjects who had stopped immunosuppressive drugs for at least 1 month can be enrolled.)
• Female subjects who are pregnant, breastfeeding or planning for pregnancy within 1 year after CAR-T cell infusion, or male subjects whose partners are planning for pregnancy within 1 year after CAR-T cell infusion;
• Any conditions that would, in the investigator's assessment, increase risks in patients or interfere with the outcomes of the trial.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• Fundamenta Therapeutics, Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jia Chen, M.D., Ph.D.

CONTACT

+86-512-67781856; drchenjia@163.com

Jun Li, Ph.D.

CONTACT

+86-18662604088; jli@ctigen.com

Study Design

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

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 19, 2023
• Study Start: December 1, 2022
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 19, 2023

Record last verified: 2022-12

Locations

CN (1)