IL-8 receptor–modified CAR T cells for brain metastases in adults

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

Adults with brain metastases from any primary cancer will be screened and may receive standard therapies before CAR T-cell manufacture. If eligible, their own T cells are collected, engineered to express CD70 CAR with an IL-8 receptor, and prepared for infusion after a 28-day safety observation. Standard-of-care treatments may continue as a bridge while the CAR T cells are being manufactured, with disease status reviewed by imaging before and after cellular therapy. Treatment procedures include coordination with existing brain-directed therapies and ongoing monitoring for safety and feasibility.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histological confirmation of primary cancers
* Histologic confirmation of CD70 on primary tumor, lymph node, or BM biopsy CD70-positive tumor expression confirmed by the investigational CD70 IHC assay defined as CD70 immunoreactivity in ≥ 5% of tumor cells at any staining intensity.
* At least one recurrent or progressive metastatic lesion or new metastatic lesion(s).
* KPS ≥ 70.
* 18 years or older.
* Adequate bone marrow and organ function as defined below:

  * CBC with differential with adequate bone marrow function as defined below:
  * Absolute neutrophil count (ANC) ≥ 1000 cells/mm3.
  * Platelet count ≥ 75,000 cells/mm3.
  * Hemoglobin ≥ 9 g/dl. (use of transfusion or other intervention to achieve Hgb ≥ 9 g/dl is acceptable.)
* Adequate renal function as defined below:

  * BUN ≤ 25 mg/dl
  * Creatinine ≤ 1.7 mg/dl
* Adequate hepatic function as defined below:

  * Bilirubin ≤ 2.0 mg/dl
  * ALT ≤ 5 times institutional upper limits of normal for age
  * AST ≤ 5 times institutional upper limits of normal for age
* A diagnostic contrast-enhanced brain MRI must be performed within 28 days prior to study enrollment.
* For females of childbearing potential, a negative serum pregnancy test at enrollment.
* Women of childbearing potential (WOCBP) must be willing to use an acceptable contraceptive method to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.
* Males with female partners of childbearing potential must agree to practice adequate contraceptive methods throughout the study and should avoid conceiving children for 24 weeks following the last dose of the study drug.
* Ability of the patient to understand and willingness to sign an IRB approved written informed consent document.
* Steroid dose equivalent to dexamethasone dose of ≤ 6mg daily at the time of enrollment.
* Patients treated on any other investigational therapy must discontinue that treatment prior to study entry.

Exclusion Criteria:

• Known immunosuppressive disease or human immunodeficiency virus (HIV) infection.

Rationale: The need to exclude patients with an immunosuppressive disease or human immunodeficiency virus infection is necessary because the management of potential toxicities from the study drug may involve treatment that is significantly immunosuppressive.

* Participant has ongoing toxicity ≥ grade 2 per the CTCAE version 5.0 considered clinically significant and in the opinion of the investigator, attributable to prior antineoplastic therapies.
* Participant has received any chemotherapy or other immunotherapy within 14 days prior to the first dose of study intervention.
* Severe, active co-morbidity, defined as follows:

  * Unstable angina and/or congestive heart failure requiring hospitalization.
  * Transmural myocardial infarction within the last 6 months.
  * Acute bacterial or fungal infection requiring intravenous antibiotics.
  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization.
  * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
  * Patients with an autoimmune disease requiring medical management with immunosuppressants.
  * Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.
* Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant.

Where it's running

• UF Health
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Maryam Rahman, MD — University of Florida
• Study coordinator: Taryn King, RN
• Email: Wells-BTC@ufl.edu
• Phone: 3522739000

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

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

  This trial tries CD5 CAR T-cell therapy, using either the patient's own cells or donor cells, and may bridge to stem-cell transplant for people 14–70 with relapsed or refractory T-cell lymphoma.

  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

• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

  This study is testing if a combination of golcadomide and rituximab can help patients with aggressive B-cell lymphoma get ready for CAR T-cell therapy.

  Recruiting at 7 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 6 other locations · NCT06834373

• Loncastuximab tesirine plus rituximab as bridging therapy before CAR-T for relapsed or refractory large B‑cell lymphoma

  This trial tries loncastuximab tesirine with rituximab as a bridge before commercial CD19 CAR‑T therapy for adults with relapsed or refractory large B‑cell lymphoma to see if it is safe and helps control disease before CAR‑T.

  Recruiting at 2 sites Phase 2 University of Utah · Chapel Hill, North Carolina and 1 other locations · NCT06788964

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.