Using engineered immune cells to treat relapsed or refractory B-cell cancers

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 investigates the use of CD19.CAR allogeneic NKT cells to treat patients with relapsed or refractory B-cell malignancies, including various forms of lymphoma and leukemia. The approach involves gene transfer to enhance immune cells, allowing them to target and destroy cancer cells more effectively. Patients will receive a dose of these engineered cells after undergoing a preparatory regimen with cyclophosphamide and fludarabine to reduce their own immune cells. The study will monitor patients for long-term effects over a period of 15 years.

Why it matters

Who can join: the full rules

Treatment Inclusion Criteria:

1. Diagnosis of CD19-positive B-cell lymphoma or leukemia (ALL or CLL).
2. The disease is:

   Cohort A (non-ALL patients):
   1. Relapsed or refractory after two or more lines of therapy, including a CD20 antibody, if an indolent lymphoma.
   2. Relapsed or refractory after two or more lines of therapy, including ibrutinib and venetoclax, if CLL.
   3. Relapsed or refractory after two or more lines of therapy, including a CD20 antibody and an anthracycline, and the patient is ineligible for autologous stem cell transplantation, if an aggressive or highly aggressive lymphoma.

      * Ineligibility for autologous stem cell transplantation includes non-responsive disease after salvage therapy and failure to mobilize stem cells for transplant.

   Cohort B (ALL patients)

   a. Relapsed or refractory after two or more lines of therapy, if ALL.
3. Measurable disease by current criteria (Lugano criteria for lymphomas, IWG criteria for CLL, and detectable disease for ALL).
4. Age ≥ 3 and ≤75 years.
5. Bilirubin \< 2 times (3 times if Gilbert syndrome) upper limit of normal
6. AST and ALT less than 5 times the upper limit of normal.
7. Estimated GFR ≥ 50 mL/min.
8. Pulse oximetry of ≥ 90% on room air
9. Karnofsky or Lansky score of ≥ 70.
10. Recovered from the acute toxic effects of all prior chemotherapy based on the enrolling physician's assessment (if some effects of chemotherapy are expected to last long term, patient is eligible if meeting other eligibility criteria).
11. Life expectancy of greater than 12 weeks.
12. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
13. Patients must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.

Treatment Exclusion Criteria:

1. Currently receiving any investigational agents or received any cellular therapies within the previous 6 weeks.
2. History of hypersensitivity reactions to murine protein-containing products.
3. History of grade 2 to 4 graft-versus-host disease (GVHD)
4. Pregnant or lactating.
5. Active infection with HIV or HTLV.
6. Active infection with HBV or HCV.
7. Uncontrolled active bacterial, fungal or other viral infection.

Where it's running

• Houston Methodist Hospital
  Houston, Texas, United States Recruiting
• Texas Children's Hospital
  Houston, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Carlos Ramos, MD — Baylor College of Medicine
• Study coordinator: Carlos Ramos, MD
• Email: caramos@bcm.edu
• Phone: (832) 824-4817

Similar studies

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

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• Ronde-cel versus standard CD19 CAR T‑cell therapy for relapsed or refractory large B‑cell lymphoma

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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.