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Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma | Clinical Trials | Clareo Health

RECRUITINGNA

Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma

An Early Exploratory Clinical Study of Enhanced Autologous CAR-T Cell Injection (ECAR01) Targeting CD19 and BCMA in Patients With Relapsed or Refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma

NCT06961669•Anhui Provincial Hospital

View on ClinicalTrials.gov

Summary

This is an open label, single-site, dose-escalation study in up to 18 participants with Relapsed or Refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART

Eligibility

Age

3 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient or his/her guardian is fully informed and agrees to participate in this clinical study and signs the informed consent form;
•2. At the time of signing the informed consent form, be over 3 years of age, regardless of gender;
•3. Patients with a confirmed diagnosis of acute B-cell leukemia/B-cell lymphoma/multiple myeloma who meet one of the following criteria:
•1. B diffuse large B-cell lymphoma (DLBCL), germinal center, or activated B-cell type; Primary cutaneous DLBCL; Primary mediastinal (thymic) large B-cell lymphoma; ALK anaplastic large B-cell lymphoma; High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement (i.e., "double or triple hit"); High-grade B-cell lymphoma; T-cell-rich B-cell lymphoma; transformed follicular lymphoma; or any aggressive B-cell lymphoma caused by indolent lymphoma; follicular lymphoma; mantle cell lymphoma; Patients with large cell transformation (Richter's Transformation) with CLL who have not achieved remission or have progressed after achieving remission after at least 1 prior line of therapy.
•2. Patients diagnosed with acute B-cell leukemia: Patients who have achieved relapse after achieving remission after prior chemotherapy; or patients who have failed to achieve remission (\<5% bone marrow blasts or persistent extramedullary or central nervous system disease) after 2 prior cycles of induction chemotherapy, or who still maintain MRD.
•3. Multiple Myeloma: Patients with confirmed diagnosis of multiple myeloma and patients with relapsed or refractory multiple myeloma according to IMWG 2016 diagnostic criteria.
•4. For patients with B-cell lymphoma, according to the recommendations for initial evaluation, staging, and response evaluation of Hodgkin and non-Hodgkin lymphoma (2014 edition), at least one measurable lesion in the baseline period, i.e., lymph node lesions with a length diameter of \> 15 mm, or an extranodal lesion with a length diameter of \> 10 mm according to PETCT or CT imaging;
•5. For patients with B-ALL, the proportion of bone marrow primitive and naïve lymphocytes in the screening period ≥5%;
•6. CD19 expression of tumor cells confirmed by flow cytometry or immunohistochemistry: the proportion of CD19 cells detected by peripheral blood flow cytometry in patients with B-ALL was ≥30%, and the proportion of CD19 cells in patients with B-cell lymphoma was positive by immunohistochemistry;
•7. Adequate function of vital organs: liver function satisfies ALT≤3×ULN, AST≤3×ULN; serum creatinine≤140μmol/L; Total bilirubin ≤ 2× ULN, and total bilirubin ≤ 3.0× ULN for patients with Gilbert syndrome; Haemodynamically stable and left ventricular ejection fraction (LVEF) ≥45% as determined by echocardiography or multichannel radionuclide angiography (MUGA); No active pulmonary infection, transcutaneous arterial oxygen saturation ≥92% in non-oxygen-based state;
+3 more criteria

Exclusion Criteria

•1. Episodes of central nervous system disease or presence of pathological changes within 6 months prior to screening, including but not limited to: stroke, stroke, aneurysm, epilepsy, convulsions, aphasia, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or mental disorder;
•2. patients with B-ALL with confirmed diagnosis of isolated extramedullary recurrence;
•3. presence of malignancies other than acute B-cell leukemia/B-cell lymphoma;
•4. Received the following anti-tumor therapies before cell collection: chemotherapy, targeted therapy, and other drug therapy within 14 days or at least 5 half-lives; Radiotherapy within 14 days;
•5. Vaccination, B-cell targeted therapy within 4 weeks prior to screening;
•6. Patient has systemic autoimmune disease or immunodeficiency;
•7. Grade 2\~4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks prior to screening;
•8. Patients with relatively serious heart disease, such as angina, myocardial infarction, heart failure and arrhythmia;
•9. History of severe allergy to drugs used in clinical studies or raw and excipient materials of experimental drugs, such as cyclophosphamide, fludarabine, DMSO, etc.;
•10. Patient has active hepatitis B, or positive HCV antibody, or HIV antibody, or syphilis;
+3 more criteria

Locations (1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, China

Key Dates

Start Date

April 16, 2025

Primary Completion Date

August 31, 2028

Completion Date

August 31, 2028

Last Updated

May 29, 2025

Enrollment

ESTIMATED participants

Conditions

Lymphoblastic LeukemiaRelapsed or Refractory Multiple Myeloma (RRMM)

Interventions

Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis

DRUG

Contacts

bing xing wang, M.D

CONTACT

860551-62284476 wangxingbing@ustc.edu.cn

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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: May 29, 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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Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma

Inclusion Criteria

Exclusion Criteria

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