Using patients' own modified immune cells to treat certain blood cancers
Official title: 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
Run by Anhui Provincial Hospital · NCT06961669 · Data updated 2026-11-12
This study is testing a new treatment using modified immune cells to see if it can help people with certain blood cancers like multiple myeloma, leukemia, and lymphoma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years and up |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | Anhui Provincial Hospital Government |
| Drugs / interventions | chemotherapy, cyclophosphamide, fludarabine, CART |
| Locations | 1 site (Hefei) |
| Status | Recruiting |
| Started | April 16, 2025 |
| Main results expected | August 31, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | May 29, 2025 |
| Trial ID | NCT06961669 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients over 3 years old with a confirmed diagnosis of specific aggressive B-cell malignancies.
✕Probably not a fit
Patients with non-B-cell malignancies or those who do not meet the inclusion criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, single-site study involves administering intravenous autologous CD19 CAR-T cells to patients with Relapsed or Refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma. The study aims to evaluate the safety and efficacy of this innovative treatment approach, which utilizes engineered immune cells to target and destroy cancer cells. Up to 18 participants will be enrolled, and the treatment will be given as a one-time injection. The study will assess how well this therapy works and its potential side effects.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients with difficult-to-treat blood cancers.
How similar studies have gone: Other studies using CAR-T cell therapies have shown promising results, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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; 8. ECOG score: 0\~2 points; 9. As judged by the investigator, the patient has an expected survival of more than 3 months; 10. Subjects of childbearing potential agree to use a reliable and effective method of contraception (excluding contraception during the safe period) for 2 years from the time of signing the informed consent form until receiving ECAR01 cell infusion. 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; 11. Presence of active infection requiring intravenous antibiotics or hospitalization; 12. Pregnant or lactating women; 13. Other investigators believe that the subject is not suitable to participate in this clinical study because it will affect the safety and efficacy judgment of the subject, or for other reasons;
Where it's running
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The First Affiliated Hospital of University of Science and Technology of China
Hefei, China Recruiting
Study contacts
- Principal investigator: bing xing wang, M.D — The First Affiliated Hospital of University of Science and Technology of China
- Study coordinator: bing xing wang, M.D
- Email: wangxingbing@ustc.edu.cn
- Phone: 860551-62284476
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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In Vivo PICX CAR-T Therapy for Relapsed or Refractory Multiple Myeloma
A single-arm study is testing an in vivo CAR-T cell therapy (PICX Injection) to see if it is safe and can help people with relapsed or refractory multiple myeloma.
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F182112 versus standard care for relapsed or refractory multiple myeloma
This study will test whether F182112 works better than standard treatments for adults whose multiple myeloma has come back or stopped responding after prior therapies including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
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Dual-target BCMA and GPRC5D CAR-T for relapsed/refractory multiple myeloma with extramedullary disease
This will try a CAR-T cell treatment that targets both BCMA and GPRC5D for adults whose relapsed or refractory multiple myeloma has spread outside the bone marrow.
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Dual-target BCMA–CD19 CAR-T therapy for relapsed or refractory multiple myeloma with extramedullary disease
This trial will try a CAR-T treatment that targets both BCMA and CD19 for adults whose relapsed or refractory multiple myeloma has spread outside the bone marrow.
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Comparing BMS-986393 with standard treatments for relapsed multiple myeloma
This study is testing a new drug called BMS-986393 to see if it works better than standard treatments for adults with relapsed multiple myeloma who haven't responded to lenalidomide.
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Combining Purinostat Mesylate with Pomalidomide and Dexamethasone for Multiple Myeloma
This study is testing if a new combination of medications can be safely used to help people with relapsed or hard-to-treat multiple myeloma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.