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New treatment option for Relapsed or Refractory Follicular Lymphoma
Official title huCART19-IL18-eDHFR Cells in Relapsed/Refractory Follicular Lymphoma
ClinicalTrials.gov ID: NCT07343934
What this study is testing
What is huCART19-IL18-eDHFR cells?
huCART19-IL18-eDHFR cells is an investigational medicine, being studied as a potential treatment for relapsed or refractory follicular lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 1, open-label study to evaluate the feasibility, safety and preliminary efficacy of huCART19-IL18-eDHFR cells administered in patients with relapsed or refractory follicular lymphoma. This study will be initiated as a single arm study (Treatment Arm A), which will evaluate the use of huCART19-IL18-eDHFR cells without prior lymphodepletion.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed informed consent form
- Male or females age ≥ 18 years
- Diagnosis of follicular lymphoma, grades 1-3A
- Relapsed or refractory disease after at least 2 prior lines of systemic therapy as follows:
- Prior therapy must include an anti-CD20 monoclonal or bispecific antibody and an alkylating agent.
You likely can't join if
- Active hepatitis B or hepatitis C infection
- Any active, uncontrolled infection.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification (See Appendix 5).
- Clinically apparent arrhythmia or arrhythmias that are not stable on medical management within two weeks of physician-investigator confirmation of...
- Severe, active co-morbidity that, in the opinion of the physician-investigator, would preclude participation in this study.
- Active acute or chronic GVHD requiring systemic therapy.
See the full eligibility criteria
- Signed informed consent form
- Male or females age ≥ 18 years
- Diagnosis of follicular lymphoma, grades 1-3A
- Relapsed or refractory disease after at least 2 prior lines of systemic therapy as follows:
- Prior therapy must include an anti-CD20 monoclonal or bispecific antibody and an alkylating agent.
- Must have progressed within 2 years after second or higher line of therapy.
- Documentation of CD19 expression on malignant cells by flow cytometry/IHC from a CLIA certified laboratory. Results must be within 6 months of physician-investigator confirmation of eligibility and after any intervening...
- Patients with relapsed disease after prior allogeneic SCT must meet the following criteria:
- Have no active GVHD and require no immunosuppression
- Are more than 6 months from transplant at the time of physician-investigator confirmation of eligibility
- Evidence of progressive disease within 12 weeks of physician-investigator confirmation of eligibility.
- ECOG Performance Status that is either 0 or 1.
- Adequate organ function defined as:
- Serum creatinine ≤ 1.5x ULN or estimated creatinine clearance ≥ 35 mL/min and not on dialysis.
- ALT/AST ≤ 3 x ULN
- Direct bilirubin ≤ 2.0 mg/dl; for patients with Gilbert's syndrome direct bilirubin must be ≤ 3.0 mg/dl
- Left Ventricular Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA
- Must have minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air
- Active hepatitis B or hepatitis C infection
- Any active, uncontrolled infection.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification (See Appendix 5).
- Clinically apparent arrhythmia or arrhythmias that are not stable on medical management within two weeks of physician-investigator confirmation of eligibility.
- Severe, active co-morbidity that, in the opinion of the physician-investigator, would preclude participation in this study.
- Active acute or chronic GVHD requiring systemic therapy.
- Dependence on systemic steroids or immunosuppressant medications. For additional details regarding use of steroid and immunosuppressant medications, please see Section 5.3.
- Receipt of prior huCART19 or huCART19-IL18 therapy.
- Active treatment with trimethoprim, methotrexate, or other antifolate chemotherapy, or anticipated use of these drugs during the active treatment phase of the study. For additional details regarding these restrictions...
- Active CNS involvement. Patients with a history of CNS involvement that was successfully treated are eligible. A CNS evaluation is only required for eligibility if a subject is experiencing signs/symptoms of CNS...
- Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen.
- Known allergy to trimethoprim or Bactrim (TMP-SMX).
- History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
- Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg daily of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
- Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods, as described in Protocol Section 4.3.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.