Actively Recruiting
CAR T Cells 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
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
One arm, open label study to assess the clinical use of Investigational Medicinal Product FCTX-CL19-1 (scientific name: Tarcidomgen Kimleucel) containing autologous anti-CD19 CAR T cells with a preliminary determination of the safety of intravenous IMP administration in patients diagnosed with refractory and relapsed CD19 + B cell neoplasms.
CONDITIONS
Official 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...
- Adults aged 18 to 65 years inclusive
- Diagnosed with 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
- Body weight between 40 kg and 130 kg
- Adequate organ function including liver enzymes, heart function, oxygen saturation, and kidney function
- Negative tests for hepatitis C, hepatitis B, HIV, and syphilis
- Negative pregnancy test for women of reproductive age before key procedures
- Expected survival of at least 12 months from screening
- Agreement to use effective contraception from consent until 6 months after therapy
- Last COVID-19 vaccine dose 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 unrelated to cancer relapse
- Bulky or rapidly progressing disease
- Less than 3 months since allogeneic hematopoietic stem cell transplantation or donor lymphocyte infusion
- High-dose chemotherapy within 4 weeks before planned apheresis
- Presence of another active malignancy or malignancy diagnosed within 2 years before enrollment
- Body weight below 40 kg or above 130 kg
- Active bacterial, viral, or fungal infections including COVID-19
- Latent infections with hepatitis B, hepatitis C, HIV, or syphilis
- Other medical conditions that may interfere with safety in the investigator's opinion
- Allergies to penicillin, streptomycin, or amphotericin B
- Previous intolerance to cyclophosphamide or fludarabine
- Chronic systemic immunosuppressive treatment except low-dose corticosteroids
- Immunosuppression for graft-versus-host disease after allogeneic transplant
- Pregnancy
- Not agreeing to use effective contraception during the trial or breastfeeding without stopping during the trial
- Unable to provide informed consent
- Lack of approved COVID-19 vaccination
- Not fluent in Polish language
- Previous treatment with anti-CD19 CAR T therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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