Actively Recruiting
Application of the Autologous CAR T Cells (Tarcidomgen Kimleucel) in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms
Led by FamiCordTx · Updated on 2024-09-19
6
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary effectiveness of a new investigational medicinal product called FCTX-CL19-1 (Tarcidomgen Kimleucel), which contains autologous anti-CD19 CAR T cells. This phase I open-label study focuses on patients with relapsed or refractory CD19-positive B cell cancers, including acute lymphoblastic leukemia, mantle cell lymphoma, and large B-cell lymphoma. The study aims to see if this gene therapy approach is safe and can induce remission in these treatment-resistant cancers. The treatment involves a single intravenous dose of FCTX-CL19-1 administered by investigators during hospitalization. The dose ranges from 0.2 to 2 million CAR T cells per kilogram of the patient's body weight. This therapy uses the patient's own modified T cells engineered to target CD19 on malignant B cells. The study carefully monitors the safety of this administration and evaluates responses in terms of remission and treatment failures. Participants will be closely observed throughout the study, which lasts about one year on average. Researchers will assess side effects such as cytokine release syndrome and neurological events, as well as infections, cytopenia, and other adverse events. They will also monitor the participants' response to therapy, including complete or partial remission rates. Patients undergo regular clinical evaluations, lab tests, and organ function assessments to ensure safety and to measure outcomes during the study period.
CONDITIONS
Brief Title
CAR T Cells in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 to 65 years inclusive
- Diagnosis of refractory or relapsed CD19-positive B cell cancers including acute lymphoblastic leukemia, large B-cell lymphoma, or mantle cell lymphoma
- Confirmed CD19 expression on malignant cells
- ECOG performance status of 0 or 1
- Patient weight between 40 kg and 130 kg
- Adequate organ function including liver enzymes, heart ejection fraction above 50%, oxygen saturation above 93%, and kidney function
- Negative tests for HCV, HBV, HIV, and syphilis
- Negative pregnancy test for women of reproductive age at screening and before treatment
- Expected survival time of at least 12 months from screening
- Agreement to use effective contraception from consent until 6 months after therapy
- Last dose of COVID-19 vaccination at least 6 months before enrollment
- Able to provide written informed consent
- Fluent in Polish language
You will not qualify if you...
- Significant central nervous system diseases not related to cancer relapse
- Bulky or rapidly progressing disease
- Less than 3 months since allogeneic stem cell transplant or donor lymphocyte infusion
- High-dose chemotherapy within 4 weeks before scheduled cell collection
- Presence of another active cancer within 2 years before trial
- Weight below 40 kg or above 130 kg
- Active infections including SARS-CoV-2
- Latent infections with HBV, HCV, HIV, or syphilis
- Any other disease interfering with trial safety
- Allergy to penicillin, streptomycin, or amphotericin B
- Previous intolerance to cyclophosphamide or fludarabine
- Chronic systemic immunosuppression (except low-dose corticosteroids)
- Immunosuppression for graft-versus-host disease after prior transplant
- Pregnancy
- Refusal to use effective contraception during trial
- Inability to provide informed consent
- Lack of approved COVID-19 vaccination
- Not fluent in Polish
- Prior treatment with anti-CD19 CAR T therapy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (Day 0)
Participants receive one intravenous administration of the CAR T cell therapy (FCTX-CL19-1) during hospitalization.
1 administration visit (in-person)
Duration - Up to 1 year
Participants are monitored for safety and efficacy outcomes including adverse events and response to therapy for up to approximately 1 year after treatment.
Regular follow-up visits during the year (in-person)
Trial Site Locations
Total: 2 locations
1
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego - Centralny Szpital Kliniczny
Warsaw, Ul. Banacha 1a, Poland, 02-097
Actively Recruiting
2
Uniwersyteckie Centrum Kliniczne Gdańskiego Uniwersytetu Medycznego - Katedra i Klinika Hematologii i Transplantologii
Gdansk, Ul. Smoluchowskiego 17, Poland, 80-214
Actively Recruiting
Research Team
N
Natalia Żmijewska
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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