ThisCART19A Bridging to alloHSCT for R/R B-ALL

NCT05679687 | Unknown Phase 1

• 1 other identifier: SZ4602
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

CAR; Refractory Acute Lymphoblastic Leukemia; Relapsed Adult ALL

Keywords

Universal CAR-T; allogeneic HCT

Outcome Measures

Primary Outcomes (2)

• ORR

  Overall response rate

  4 week

• MRD Negativity

  MRD Negativity is assessed utilizing multicolor flow cytometry to detect leukemia cells with a sensitivity of 10\^ (-4).

  4 week

Secondary Outcomes (8)

• CR

  2 year

• CRi

  2 year

• CRh

  2 year

• BFBM

  2 year

• PR

  2 year

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Drug: Treatment

Interventions

Treatment DRUG

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.

Treatment

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign a documented IRB-approved ICF prior to any screening procedure.
• No gender limitation, 14 years ≤ age ≤ 65 years.
• Intention to HSCT therapy.
• 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.
• Life expectancy ≥ 8 weeks at the time of enrollment.
• Eastern Cooperative Oncology Group performance status score of 0 or 1.
• Adequate bone marrow, renal, hepatic, pulmonary and cardiac function:
• Adequate marrow function for lymphodepletion chemotherapy assessed by the investigator.
• Creatinine clearance \> 30 mL/min according to the Cockcroft-Gault formula;
• 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.)
• Oxygen saturation (SaO2) ≥ 92% on room air.
• Cardiac function：left ventricular ejection fraction (LVEF) ≥ 40% assessed by echocardiography.
• CD19-positive leukemia obtained from bone marrow or peripheral blood confirmed by flowcytometry or biopsy during screening.

You may not qualify if:

• Allergic to preconditioning measures.
• History of allogeneic HSCT.
• 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.)
• Severe active infection. (Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted.)
• Pulmonary embolism within 3 months prior to enrollment.
• Severe cardiovascular and cerebrovascular diseases and hereditary diseases intolerant to CAR-T therapy assessed by the investigator prior to enrollment.
• Presence of symptomatic CNS involvement (both primary and secondary) at screening confirmed by imaging;
• 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.)
• 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.)
• 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

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; 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: NA
• 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 11, 2023
• Study Start: December 1, 2022
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 11, 2023

Record last verified: 2022-12

Locations

CN (1)