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The PACMAN-Hu19 trial: a phase I/II study with locally produced CD19-targeted CAR T-cell therapy
EU CTIS ID: 2023-507597-40-00
What this study is testing
To determine the incidence of DLT within 28 days after CAR T-cel infusion (huCAR19), which will result in the recommended phase 2 dose (RP2D)
- 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
- 1-45 years of age
- Additional inclusion criteria phase I part of the study: The first three patients in the phase 1 part of the study must be aged 12-45 years, thereafter patients of any age between 1-45 years can be recruited once surrogate endpoint of B-cell Aplasia is reached in ≥60% patients in previous or current dose level.
- Patients with relapsed or refractory CD19+ hematological malignancies (a.o. B-NHL and B-cell precursor)
- Measurable disease (at least one measurable lesion or at least 0.1% of blast in bone marrow)
- Patients must have exhausted or are ineligible for all registered therapeutic options with curative potential.
- Adequate performance score
You likely can't join if
- Patients with symptomatic CNS involvement will be excluded. After resolution and control of symptoms, patients can be rescreened.
- Concurrent malignancy requiring treatment of having been treated <3 months before screening except for curatively treated basal cell carcinoma of the skin
- Pregnant women
- Patients unable to participate in the study according to investigator judgement
- Patients not willing or unable to adhere to protocol guidelines or follow-up.
- Treatment with allogeneic stem cell transplantation <12 weeks from screening or DLI <4 weeks from screening or active GVHD requiring systemic treatment. Cutaneous GVHD requiring only topical steroids is allowed.
See the full eligibility criteria
- 1-45 years of age
- Additional inclusion criteria phase I part of the study: The first three patients in the phase 1 part of the study must be aged 12-45 years, thereafter patients of any age between 1-45 years can be recruited once surrogate endpoint of B-cell Aplasia is reached in ≥60% patients in previous or current dose level.
- Patients with relapsed or refractory CD19+ hematological malignancies (a.o. B-NHL and B-cell precursor)
- Measurable disease (at least one measurable lesion or at least 0.1% of blast in bone marrow)
- Patients must have exhausted or are ineligible for all registered therapeutic options with curative potential.
- Adequate performance score
- Patients from childbearing potential must be willing and able to use highly effective methods of birth control from first chemotherapy infusion through 12 months after administering the last study treatment
- Patients must be willing to abstain from breast feeding through 12 months after administering the last study treatment.
- Patients must agree to refrain from donating blood or organs following treatment with huCAR19 T-cells.
- Written informed consent per local law and regulations.
- Patients with symptomatic CNS involvement will be excluded. After resolution and control of symptoms, patients can be rescreened.
- Concurrent malignancy requiring treatment of having been treated <3 months before screening except for curatively treated basal cell carcinoma of the skin
- Pregnant women
- Patients unable to participate in the study according to investigator judgement
- Patients not willing or unable to adhere to protocol guidelines or follow-up.
- Treatment with allogeneic stem cell transplantation <12 weeks from screening or DLI <4 weeks from screening or active GVHD requiring systemic treatment. Cutaneous GVHD requiring only topical steroids is allowed.
- Hypersensitivity to the active substance
- Active uncontrolled or life-threatening infections
- Infection with HTLV-1, HTLV-2, HIV-1, HIV-2, hepatitis B (HbsAg positive) or hepatitis C (anti-HCV positive). Chronic controlled hepatitis B or C infection with undetectable viral load or controlled HIV infection with viral load <50 IU/ml and CD4+ T-cell count >200/ml may be considered when antiviral prophylaxis or therapy can be administered.
- Absolute neutrophil count <0.5x10E9/L unless caused by underlying disease
- Platelet count <25x10E9/L unless caused by underlying disease
- Bilirubin and/or transaminases ≤ 2.5 x ULN, unless caused by underlying disease.
- Renal insufficiency
- Inadequate pulmonary function defined as baseline oxygen saturation <92%, if not caused by underlying disease.
- Inadequate cardiac function
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, 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.