CD19 CAR-T therapy for B-cell non-Hodgkin's lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of CD19 CAR-T cell therapy in patients with B-cell non-Hodgkin's lymphoma. It is a single-arm, open-label study conducted at a single center, enrolling 36 patients who have CD19+ non-Hodgkin's lymphoma and are unwilling to undergo standard chemotherapy. Participants will receive preconditioning regimens before the CAR-T cell therapy, and the primary focus is on assessing dose-related safety outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age no less than 18, no gender limit;
2. Newly diagnosed high-risk Large B-cell Lymphoma, which was defined by the following criteria: (1) DLBCL not otherwise specified with an IPI score ≥3 at diagnosis, (2) high grade B-cell lymphoma (HGBL) with gene rearrangement of MYC and BCL2 and/or BCL6, (3) HGBL not otherwise specified;
3. Confirmed CD19 and CD20 postive expressions in lymphoma cells
4. ECOG score 0-2;
5. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
6. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
7. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
8. Estimated survival time ≥ 3 months;
9. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Central nervous system involvement by lymphoma；History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
4. Active infection of hepatitis B virus or hepatitis C virus;
5. Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
6. Insufficient amplification capacity in response to CD3/CD28 co-stimulus signal (\<5 times) ;
7. Other uncontrolled diseases that were not suitable for this trial;
8. Patients with HIV infection;
9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Where it's running

• The First Affiliated Hospital，College of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: He Huang, PhD
• Email: hehuangyu@126.com
• Phone: 86-13605714822

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• Academic anti-CD19 CAR-T for relapsed or refractory large B‑cell lymphoma

  This project tests whether a locally manufactured anti‑CD19 CAR‑T cell therapy works and is safe for adults whose large B‑cell lymphoma has relapsed or not responded to prior treatment.

  Recruiting N.N. Alexandrov National Cancer Centre · Lyasny, Minsk Oblast · NCT07524816

• Adding CLS-015 to anti-CD19 CAR-T therapy for large B‑cell lymphoma during lymphodepletion

  This trial tests whether giving CLS-015 (an enzyme that breaks down NETs) alongside anti‑CD19 CAR‑T therapy helps adults with large B‑cell lymphoma who have stable or progressing disease at the time of lymphodepletion.

  Recruiting Phase 1 Tel-Aviv Sourasky Medical Center · Tel Aviv · NCT07361224

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

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  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing and 2 other locations · NCT07022964

• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

  This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.

  Recruiting at 11 sites Phase 2 National Cancer Institute (NCI) · Duarte, California and 10 other locations · NCT07003295

• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

  This study is testing a new CAR T-cell therapy for people with T-cell lymphomas that haven't responded to regular treatments to see if it is safe and effective.

  Recruiting at 4 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06925464

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.