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Trial Title: ThisCART19A Bridging to alloHSCT for R/R B-ALL

NCT ID: NCT05679687

Condition: CAR
Refractory Acute Lymphoblastic Leukemia
Relapsed Adult ALL

Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid

Conditions: Keywords:
Universal CAR-T
allogeneic HCT

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Treatment
Description: In this study, allogeneic anti-CD19 CAR T cells (ThisCART19A) infusion is used as a bridge therapy to hematopoietic stem cell transplantation to treat patients with refractory or relapsed CD19 positive B cell acute lymphoblastic leukemia. Lymphodepletion conditioning before CAR T cell infusion consists of fludarabine, CTX and VP-16.
Arm group label: Treatment

Summary: This is a phase 1, open-label study to assess the efficacy, safety and pharmacokinetics of ThisCART19A (Allogeneic Anti CD19 CAR-T) bridging to HSCT in patients with refractory or relapsed B cell acute lymphoblastic leukemia (r/r B-ALL).

Detailed description: This is a phase 1, single-center, nonrandomized, open-label, dose-escalation study to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A bridging to HSCT in patients with CD19 positive r/r B-ALL and identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile. Before initiating ThisCART19A infusion, subjects will be administered lymphodepletion chemotherapy composed of fludarabine、cyclophosphamide and VP-16. At Day 0 of the Treatment Period, subjects will receive an intravenous (IV) infusion of ThisCART19A. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of ThisCART19A will be followed up to 2 years.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Voluntarily sign a documented IRB-approved ICF prior to any screening procedure. 2. No gender limitation, 14 years ≤ age ≤ 65 years. 3. Intention to HSCT therapy. 4. Meeting the diagnostic criteria of relapsed or refractory B-ALL. Relapsed B-ALL: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR. Refractory B-ALL: Failure to achieve CR or CRi at the end of induction therapy (General refers to a 4-week regimen or a Hyper-CVAD regimen); Subjects with Ph+ disease are eligible if they are intolerant to TKI therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs. 5. Life expectancy ≥ 8 weeks at the time of enrollment. 6. Eastern Cooperative Oncology Group performance status score of 0 or 1. 7. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function: 1. Adequate marrow function for lymphodepletion chemotherapy assessed by the investigator. 2. Creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula; 3. ALT and AST ≤ 5 × ULN (the upper limit of normal), total bilirubin ≤ 2×ULN. (Subjects with Gilbert syndrome or liver involvement may be included if their total bilirubin is ≤ 3 × ULN.) 4. Oxygen saturation (SaO2) ≥ 92% on room air. 5. Cardiac function:left ventricular ejection fraction (LVEF) ≥ 40% assessed by echocardiography. 8. CD19-positive leukemia obtained from bone marrow or peripheral blood confirmed by flowcytometry or biopsy during screening. Exclusion Criteria: 1. Allergic to preconditioning measures. 2. History of allogeneic HSCT. 3. Other malignancies apart from B-cell malignancies within 5 years prior to screening. (Subjects with cured skin squamous carcinoma, basal cell carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be enrolled.) 4. Severe active infection. (Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted.) 5. Pulmonary embolism within 3 months prior to enrollment. 6. Severe cardiovascular and cerebrovascular diseases and hereditary diseases intolerant to CAR-T therapy assessed by the investigator prior to enrollment. 7. Presence of symptomatic CNS involvement (both primary and secondary) at screening confirmed by imaging; 8. Active hepatitis B virus (defined as serum HBV-DNA ≥ 2000 IU/mL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment. (Subjects 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.) 9. Vaccinated with influenza vaccine within 2 weeks prior to lymphodepletion chemotherapy. (Subjects vaccinated with SARS-COV19 vaccine or inactivated, live/non-live adjuvant vaccines can be enrolled.) 10. 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. 11. Any conditions that would, in the investigator's assessment, increase risks in patients or interfere with the outcomes of the trial.

Gender: All

Minimum age: 14 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: The First Affiliated Hospital of Soochow University

Address:
City: Suzhou
Zip: 215000
Country: China

Status: Recruiting

Contact:
Last name: Depei Wu

Phone: +86 13951102021
Email: drwudepei@163.com

Start date: December 1, 2022

Completion date: November 30, 2025

Lead sponsor:
Agency: The First Affiliated Hospital of Soochow University
Agency class: Other

Collaborator:
Agency: Fundamenta Therapeutics, Ltd.
Agency class: Industry

Source: The First Affiliated Hospital of Soochow University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05679687

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