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An open label multicenter phase II study to investigate the efficacy, safety and tolerability of the Obe-cel in patients with minimal residual disease (MRD) of Philadelphia negative (Ph neg) B-precursor acute lymphoblastic leukaemia (B-ALL)
EU CTIS ID: 2025-524169-26-00
What this study is testing
To evaluate the impact of Obe-cel on event free survival at 12 months.
- Therapeutic exploratory (Phase II)
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
- Ph-negative CD19 positive B-precursor ALL patients in CR1 with molecular failure defined as MRD of 10-4 or greater after induction II of front-line therapy
- Cardiac function of LVEF > 30% ejection fraction on cardiac ultrasound
- Negative HIV, negative Hep B (HbsAg) and Hep C virus (anti-HCV), HTLV-1, HTLV-2, syphilis test
- Negative pregnancy test in women of childbearing potential
- Pancreatic function: Serum lipase ≤ 1.5 x ULN; For serum lipase > ULN - >1.5 x ULN and ≤ 3 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis.
- Woman of childbearing potential willing to use 2 highly effective methods of contraception while receiving study treatment and for an additional 3 months after the last dose of study treatment (Pearl-Index <1%). Male who has a female partner of childbearing potential willing to use 2 highly effective forms of contraception while receiving study treatment and for at least an additional 3 months after the last dose of study treatment (Pearl-Index <1%). Effective Contraception is defined as: abstinence; a hormonal contraceptive method (birth control pills, intrauterine spiral, vaginal ring, contraceptive patches, depot implants or injections) in combination with barrier methods (condoms, cervical cap, diaphragm with spermicides); Vasectomy in patients or male partners Women of childbearing potential are defined as mature women without hysterectomie or surgical sterilization or women without menopause. Menopause means without without menstruation for natural reasons for one year.
You likely can't join if
- Systemic chemotherapy prior to study treatment (except for induction I + II of front-line therapy within GMALL standards)
- Prior or ongoing second malignancy with the following exceptions: Malignancy treated with curative intent and with no known active disease present for 2 years before enrollment, no ongoing therapy and felt to be at low risk for recurrence by the treating physician; carcinoma in situ of breast or cervix cancer; non-melanoma skin cancer; breast or prostate cancer on hormonal maintenance therapy
- Current clinically relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome or psychosis), a prior history of such CNS pathology is not an exclusion criterium
- Current active relevant autoimmune disease
- Presence of active or uncontrolled fungal, bacterial, viral, or other infections requiring systemic antimicrobials for management
- Treatment with any investigational product within four weeks prior to study inclusion
See the full eligibility criteria
Who can join
- Ph-negative CD19 positive B-precursor ALL patients in CR1 with molecular failure defined as MRD of 10-4 or greater after induction II of front-line therapy
- Cardiac function of LVEF > 30% ejection fraction on cardiac ultrasound
- Negative HIV, negative Hep B (HbsAg) and Hep C virus (anti-HCV), HTLV-1, HTLV-2, syphilis test
- Negative pregnancy test in women of childbearing potential
- Pancreatic function: Serum lipase ≤ 1.5 x ULN; For serum lipase > ULN - >1.5 x ULN and ≤ 3 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis.
- Woman of childbearing potential willing to use 2 highly effective methods of contraception while receiving study treatment and for an additional 3 months after the last dose of study treatment (Pearl-Index <1%). Male who has a female partner of childbearing potential willing to use 2 highly effective forms of contraception while receiving study treatment and for at least an additional 3 months after the last dose of study treatment (Pearl-Index <1%). Effective Contraception is defined as: abstinence; a hormonal contraceptive method (birth control pills, intrauterine spiral, vaginal ring, contraceptive patches, depot implants or injections) in combination with barrier methods (condoms, cervical cap, diaphragm with spermicides); Vasectomy in patients or male partners Women of childbearing potential are defined as mature women without hysterectomie or surgical sterilization or women without menopause. Menopause means without without menstruation for natural reasons for one year.
- Ability to understand and willingness to sign a written informed consent
- Signed and dated written informed consent is available
- Participation in the registry of the German Multicenter Study Group for Adult ALL
- Molecular marker for evaluation of MRD based on individual rearrangements of either IG, TR- or KMT2A-fusion genes measured by an assay with a sensitivity of at least 10-4 being assessed in the central GMALL MRD reference laboratory in Kiel
- ECOG-Performance Status < 2
- Age ≥ 55 ≤ 75 years
- Renal function: GFR of ≥ 30 ml/min Creatinine Clearance measured by the Croft-Gault Equation
- Hepatic function: Serum alanine aminotransferase or aspartate aminotransferase <6 x ULN, total bilirubin < 3 x ULN
What rules you out
- Systemic chemotherapy prior to study treatment (except for induction I + II of front-line therapy within GMALL standards)
- Prior or ongoing second malignancy with the following exceptions: Malignancy treated with curative intent and with no known active disease present for 2 years before enrollment, no ongoing therapy and felt to be at low risk for recurrence by the treating physician; carcinoma in situ of breast or cervix cancer; non-melanoma skin cancer; breast or prostate cancer on hormonal maintenance therapy
- Current clinically relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome or psychosis), a prior history of such CNS pathology is not an exclusion criterium
- Current active relevant autoimmune disease
- Presence of active or uncontrolled fungal, bacterial, viral, or other infections requiring systemic antimicrobials for management
- Treatment with any investigational product within four weeks prior to study inclusion
- Ongoing treatment with a TKI due to presence of targetable lesions such as ABL-class translocations in Ph-like ALL.
- History of or existing hypersensitivity against the active substance or excipients of the IMP, or any drug or its ingredients that is scheduled to be given during study participation
- Existing clinical contraindications against compounds of the lymphodepleting chemotherapy regimen
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, 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.