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Autologous Bedside CD19 CAR T-cell Therapy for B-ALL | Clinical Trials | Clareo Health

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Autologous Bedside CD19 CAR T-cell Therapy for B-ALL

Clinical Study on the Safety and Efficacy of Bedside CD19 CAR T-cell Therapy for B-cell Acute Lymphoblastic Leukemia

NCT07277504•The General Hospital of Western Theater Command

Summary

The purpose of this clinical trial is to learn if autologous bedside CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat B-cell acute lymphoblastic leukemia (B-ALL) in adults. It will also learn about the safety and efficacy of the autologous bedside CD19 CAR-T cell product. The main questions it aims to answer are: 1. What adverse events occur and the incidence rate of dose-limiting toxicities (DLTs) within 28 days and CAR-T-related adverse events (AEs) after the autologous CD19 CAR-T cell infusion for B-ALL? 2. Which dose level is the optimal biological dose (OBD)? 3. What is the rate of minimal residual disease (MRD) negativity, complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), duration of response (DOR), and overall survival (OS)? Participants will: 1. Receive autologous bedside CD19 CAR T-cell therapy on Day 0. 2. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. 3. Visit the clinic at Day 7, Day 14, Day 28, then monthly for up to 12 months after CAR-T cells infusion, with continued long-term follow-up for safety and persistence.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 18 to 70 years inclusive at the time of signing informed consent.
•Documented diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Acute Lymphoblastic Leukemia (2018, Version 1) or World Health Organization (WHO) classification criteria.
•CD19 expression confirmed by flow cytometry, immunohistochemistry, or pathology on bone marrow, peripheral blood, or tissue specimens. For patients for whom current sampling is not clinically feasible, results from testing performed within 60 days prior to informed consent may be acceptable, as determined by the investigator.
•Life expectancy ≥12 weeks in the opinion of the investigator.
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
•Adequate organ function as demonstrated by the most recent assessment during the screening period, defined as:
•* Creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula)
•* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN)
•* Total bilirubin ≤1.5 × ULN (for patients with documented Gilbert's syndrome, total bilirubin ≤2.5 × ULN is acceptable)
•For women of childbearing potential (WOCBP), a negative serum pregnancy test must be documented within 7 days prior to enrollment. WOCBP and male patients with partners who are WOCBP must agree to use highly effective contraceptive methods from the screening period through 12 months after CAR-T cell infusion. Women are considered not of childbearing potential if they are postmenopausal for at least 1 year or have documented evidence of surgical sterilization or congenital infertility. Women who are pregnant or breastfeeding are excluded from this study.
+2 more criteria

Exclusion Criteria

•Active central nervous system (CNS) involvement by B-ALL, defined as CNS-2 or CNS-3 status according to standard criteria.
•History of another malignancy within 2 years prior to screening, except for adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
•Patients who previously received CAR-T cell therapy and experienced Grade ≥4 cytokine release syndrome (CRS) or neurotoxicity are specifically excluded.
•Treatment with any investigational or approved anti-B-ALL therapeutic agent within 5 half-lives prior to enrollment (excluding supportive care medications).
•Radioimmunotherapy or radiotherapy within 8 weeks prior to enrollment.
•Receipt of live attenuated vaccine within 4 weeks prior to screening.
•Current or anticipated use of systemic corticosteroids at high dose (defined as a total cumulative dose equivalent to ≥60 mg dexamethasone or equivalent corticosteroid) within 4 weeks prior to lymphodepletion chemotherapy. Physiologic replacement doses, topical, inhaled, nasal, and ophthalmic corticosteroids are permitted.
•Active acute or chronic graft-versus-host disease (GVHD) requiring systemic treatment within 4 weeks prior to CAR-T cell infusion.
•Major surgical procedure within 3 months prior to screening.
•Active CNS disorder or history of irreversible severe CNS toxicity from prior B-ALL therapy resulting in organic brain lesions or CNS dysfunction, including but not limited to seizure disorder, cerebrovascular accident, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
+32 more criteria

Locations (1)

The General Hospital of Western Theater Command

Chengdu, Sichuan, China

Key Dates

Start Date

December 1, 2025

Primary Completion Date

December 31, 2030

Completion Date

December 31, 2031

Last Updated

December 11, 2025

Enrollment

ESTIMATED participants

Conditions

B-Cell Acute Lymphoblastic Leukemia, Adult

Interventions

CD19 CAR T cells

DRUG

Contacts

Hai Yi, M.D. & Ph.D.

CONTACT

+8613699418229 yihaimail@163.com

Xiao Wang, M.D. & Ph.D.

CONTACT

xxwx@foxmail.com

CD19 Chimeric Antigen Receptor (CAR) T Cells for Adults With Recurrent or Refractory B Cell Malignancies

NCT04214886

B-Cell Acute Lymphoblastic Leukemia, AdultB-cell Lymphoma Refractory+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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