Using modified T cells to treat relapsed lymphoma

Phase I Study of Relapsed CD30 Expressing Lymphoma Treated With CD30 CAR T Cells (RELY-30)

This study is testing if specially modified T cells can help people with relapsed Hodgkin's and Non-Hodgkin lymphoma fight their cancer more effectively after chemotherapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 12 Years to 75 Years
• Sex: All
• Sponsor: Baylor College of Medicine (Academic / other)
• Drugs / interventions: chemotherapy, prednisone, CAR T
• Locations: 2 sites (Houston, Texas and 1 other locations)
• Trial ID: NCT02917083 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of genetically modified T cells, known as CD30.CAR T cells, in treating patients with relapsed or refractory Hodgkin's and Non-Hodgkin lymphoma. The study involves collecting blood from participants to extract T cells, which are then activated and modified to target cancer cells expressing the CD30 antigen. The trial follows a dose escalation approach, starting with lower doses of the modified T cells and increasing as safety is established. The goal is to determine if these modified cells can more effectively kill lymphoma cells after chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are patients aged 12 to 75 with relapsed or refractory Hodgkin's or Non-Hodgkin lymphoma that is CD30 positive.

Not a fit: Patients with tumors that do not express CD30 or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new, more effective treatment option for patients with relapsed lymphoma.

How similar studies have performed: Previous studies using CAR T-cell therapy have shown promising results in treating various types of lymphoma, indicating potential success for this approach.

Eligibility criteria

PROCUREMENT Inclusion Criteria:

1. Diagnosis of relapsed/refractory HL or NHL.
2. CD30 positive tumor as assayed in a CLIA certified pathology laboratory (result can be pending at this time)
3. Hgb ≥ 7.0 (may be a transfused value)
4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
5. Karnofsky or Lansky score of \> 60%

TREATMENT Inclusion Criteria:

1. Diagnosis of relapsed/refractory HL or NHL.
2. CD30-positive tumor as assayed in a CLIA certified pathology laboratory.
3. Age 16 to 75 for the first three patients on a dose level; thereafter, if no DLT, patients aged 12 to 75 can be treated on that dose level.
4. Bilirubin 1.5 times or less than the upper limit of normal.
5. AST 3 times or less than the upper limit of normal.
6. Estimated GFR \> 70 mL/min.
7. Pulse oximetry of \> 90% on room air
8. EKG shows no significant arrhythmias
9. Karnofsky or Lansky score of \> 60%.
10. Available autologous T cells with greater than or equal to 15% expression of CD30CAR determined by flow-cytometry.
11. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.
12. Adequate pulmonary function with FEV1, FVC and DLCO (or DLCO/VA, as clinically appropriate) greater than or equal to 50% of expected corrected for hemoglobin.
13. 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.
14. Informed consent explained to, understood by and signed by patient or guardian.

PROCUREMENT Exclusion Criteria:

1. Active infection with HIV or HTLV (can be pending at this time).
2. Active bacterial, fungal or viral infection.

TREATMENT Exclusion Criteria:

1. Currently receiving any investigational agents or received any tumor vaccines within the previous six weeks.
2. Received anti-CD30 antibody-based therapy within the previous 4 weeks.
3. Subjects with rapidly progressive disease, defined as kinetic failure to previous chemotherapy.
4. Bulky disease (defined as a 10 cm or greater mass or mediastinal disease with a transverse diameter exceeding 33% of the transthoracic diameter).
5. History of hypersensitivity reactions to murine protein-containing products.
6. Pregnant or lactating.
7. Tumor in a location where enlargement could cause airway obstruction.
8. Current use of systemic corticosteroids at a dose equivalent to 0.5 mg/kg/day of prednisone or higher.
9. Active hemorrhagic cystitis.
10. Active bacterial, viral or fungal infection.
11. Symptomatic cardiac disease (NYHA Class III or IV disease).

Where this trial is running

Houston, Texas and 1 other locations

• Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
• Texas Children's Hospital — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Carlos A Ramos, MD — Baylor College of Medicine
• Study coordinator: Carlos A Ramos, MD

Conditions Hodgkin's Lymphoma; Non-Hodgkin Lymphoma; chimeric antigen receptors; immunotherapy; CAR T-cells; lymphoma