BridgeMD
Treatment of patients with relapsed or refractory CD19+ lymphoid disease with T lymphocytes transduced by RV-SFG.CD19.CD28.4-BBzeta retroviral vector – A unicenter Phase I/II clinical trial [HD-CAR-1]
EU CTIS ID: 2024-516832-82-00
What this study is testing
The main purpose of the study is to evaluate the safety and feasibility of escalating doses of autologous activated peripheral blood T lymphocytes (ATLs) genetically modified to express third-generation CARs (comprising the CD28 and CD137 (4-1BB) costimulatory domain) that target the CD19 molecule in patients with refractory or relapsed CD19+ lymphoid disease such as ALL or NHL including CLL, DLBCL, FL and/or MCL.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Stratum 1-2 (Adults): Confirmed CD19+ ALL, CLL, DLBCL, FL or MCL in patients ≥ 18 years
- Stratum 3: Renal function defined as serum creatinine-clearance ≥ 30 mL/min/1.73 m²
- Stratum 3: Absolute lymphocyte count (ALC) ≥ 100/mm³
- Stratum 1-2 (Adults): Relapsed or refractory disease (including “molecular relapse” with minimal residual disease (MRD)
- Stratum 1-2 (Adults): Renal function defined as: serum creatinine of ≤ 2 x ULN or eGFR ≥ 30 mL/min/1.73 m²
- Stratum 1-2 (Adults): Absolute lymphocyte count (ALC) ≥ 100/mm³
You likely can't join if
- Stratum 1-2 (Adults): Immunosuppressive medication with the exception of ≤ 30 mg prednisolone/d or equivalent at the time of CAR TC transfusion
- Stratum 3: Uncontrolled acute life-threatening bacterial, viral or fungal infection
- Stratum 1-2 (Adults): Any donor lymphocyte infusions (DLI) must be completed > 6 weeks prior to CD19.CAR TC transfusion
- Stratum 1-2 (Adults): Florid/acute or chronic Graft-versus-Host disease (GvHD)
- Stratum 1-2 (Adults): Uncontrolled acute life-threatening bacterial, viral or fungal infection
- Stratum 1-2 (Adults): A primary malignancy which is in complete remission for ≥ 5 years
See the full eligibility criteria
- Stratum 1-2 (Adults): Confirmed CD19+ ALL, CLL, DLBCL, FL or MCL in patients ≥ 18 years
- Stratum 3: Renal function defined as serum creatinine-clearance ≥ 30 mL/min/1.73 m²
- Stratum 3: Absolute lymphocyte count (ALC) ≥ 100/mm³
- Stratum 1-2 (Adults): Relapsed or refractory disease (including “molecular relapse” with minimal residual disease (MRD)
- Stratum 1-2 (Adults): Renal function defined as: serum creatinine of ≤ 2 x ULN or eGFR ≥ 30 mL/min/1.73 m²
- Stratum 1-2 (Adults): Absolute lymphocyte count (ALC) ≥ 100/mm³
- Stratum 3: Age of > 3 years until < 18 years at the time of screening
- Stratum 3: CD19+ ALL (Ph+ and Ph-) confirmed by cytology and flow cytometry (FACS) AND Relapsed or refractory disease
- Stratum 3: Measurable disease/MRD at time of enrollment
- Stratum 3: Life expectancy ≥ 12 weeks
- Stratum 3: ECOG performance status ≤ 2 (age ≥ 16 years) or Lansky performance status ≥ 50 (age < 16 years) at the time of screening
- Stratum 1-2 (Adults): Immunosuppressive medication with the exception of ≤ 30 mg prednisolone/d or equivalent at the time of CAR TC transfusion
- Stratum 3: Uncontrolled acute life-threatening bacterial, viral or fungal infection
- Stratum 1-2 (Adults): Any donor lymphocyte infusions (DLI) must be completed > 6 weeks prior to CD19.CAR TC transfusion
- Stratum 1-2 (Adults): Florid/acute or chronic Graft-versus-Host disease (GvHD)
- Stratum 1-2 (Adults): Uncontrolled acute life-threatening bacterial, viral or fungal infection
- Stratum 1-2 (Adults): A primary malignancy which is in complete remission for ≥ 5 years
- Stratum 1-2 (Adults): Pregnant or nursing (lactating) women
- Stratum 3: immunosuppressive medication with the exception of < 0.5 mg/d*kg BW prednisolone-equivalent at the time of CD19.CAR TC transfusion
- Stratum 3: Any donor lymphocyte infusions (DLI) must be completed > 6 weeks prior to CD19.CAR TC transfusion
- Stratum 3: Florid/acute or chronic Graft-versus-Host disease (GvHD)
The study team makes the final eligibility decision.
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, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.