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A Phase 1/2 Study of UCART22 in B-cell Acute Lymphoblastic Leukemia (BALLI-01)
EU CTIS ID: 2022-502305-15-00
What this study is testing
For the Phase 1 Dose-escalation: -To assess the safety and tolerability of UCART22 administered to subjects with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) -To determine the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of UCART22 in patients with R/R B-ALL For the Phase 1 Sub-study FCA: -To assess the safety and tolerability of UCART22 following FCA with weight-based dosing of CLLS52 in subjects with R/R B-ALL For the Phase 2 Part 1: Lymphodepleting Optimization (CLLS52) -To determine the lowest effective dose of CLLS52 as part of the FCA LD regimen followed by the RP2D of UCART22 For the Phase 2 Part 2: UCART22 Dose-Expansion: -To evaluate the efficacy of UCART22 (following FCA) in CD22+ R/R B-ALL
- Phase I and Phase II (Integrated)- First administration to humans
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
- Age: Phase 1 and Phase 2 Part 1: Subject aged ≥ 15 years and ≤50 years; Phase 2 Part 2: Subject aged ≥12 years and ≤50 years
- Diagnosis and Prior Therapy: Phase 1: Diagnosed with R/R B-ALL; prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen. There must be no available alternative curative therapies and patients must be ineligible for allogeneic HSCT, have refused HSCT, recurred after HSCT, or have active disease that prohibits HSCT at the time of enrollment. Phase 2: Diagnosed with R/R B-ALL; Prior anti-ALL therapy must include at least one standard chemotherapy regimen and at least one salvage regimen, subjects should have received prior autologous anti-CD19 CAR T-cell therapy (unless subjects were not able to receive prior autologous anti-CD19 CAR T cell therapy for any reason or documented as CD19-negative R/R B-ALL; in the opinion of the investigator, the intended outcome is to bridge allo-HSCT.
- Disease burden: Phase 1: Subjects must have measurable or evaluable disease in the BM of at least 0.01% blasts or non-CNS extramedullary disease at the time of enrollment; Phase 1 Sub-study and Phase 2: Subjects must have measurable or evaluable disease in the BM of at least 5% blasts at the time of enrollment
- CD22 Expression: Phase 1: At least 70% of B-ALL blast cells expressing CD22 by flow cytometry performed as per standard practice; Phase 2: At least 70% of B-ALL blast cells must express CD22 by flow cytometry performed as per standard practice for the main cohort A. Subjects with CD22+ cells, but < 70% B-ALL blast cells expressing CD22 are eligible to be enrolled in the exploratory Cohort B
- ECOG performance status 0 or 1 for subjects ≥ 18 years; Lansky/Karnofsky score ≥ 70 for subjects < 18 years
- Adequate organ function, including renal and hepatic function based on the last assessment performed within the Screening Period.
You likely can't join if
- Subject is pregnant or breastfeeding;
- Burkitt cell leukemia;
- More than 1 allogeneic HSCT received;
- Prior autologous CAR T-cell therapy or investigational cell therapy within 90 days prior to enrollment; or prior allogeneic CAR T-cell therapy at any time prior to enrollment
- Prior CD22 -directed CAR T-cell therapy;
- Phase 1: Prior monoclonal and/or bispecific antibody within 30 days or 5 half-lives (whichever is longer) prior to enrollment; Phase 2: Prior monoclonal and/or bispecific antibody within 14 days or 5 half-lives (whichever is longer) prior to enrollment
See the full eligibility criteria
- Age: Phase 1 and Phase 2 Part 1: Subject aged ≥ 15 years and ≤50 years; Phase 2 Part 2: Subject aged ≥12 years and ≤50 years
- Diagnosis and Prior Therapy: Phase 1: Diagnosed with R/R B-ALL; prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen. There must be no available alternative curative therapies and patients must be ineligible for allogeneic HSCT, have refused HSCT, recurred after HSCT, or have active disease that prohibits HSCT at the time of enrollment. Phase 2: Diagnosed with R/R B-ALL; Prior anti-ALL therapy must include at least one standard chemotherapy regimen and at least one salvage regimen, subjects should have received prior autologous anti-CD19 CAR T-cell therapy (unless subjects were not able to receive prior autologous anti-CD19 CAR T cell therapy for any reason or documented as CD19-negative R/R B-ALL; in the opinion of the investigator, the intended outcome is to bridge allo-HSCT.
- Disease burden: Phase 1: Subjects must have measurable or evaluable disease in the BM of at least 0.01% blasts or non-CNS extramedullary disease at the time of enrollment; Phase 1 Sub-study and Phase 2: Subjects must have measurable or evaluable disease in the BM of at least 5% blasts at the time of enrollment
- CD22 Expression: Phase 1: At least 70% of B-ALL blast cells expressing CD22 by flow cytometry performed as per standard practice; Phase 2: At least 70% of B-ALL blast cells must express CD22 by flow cytometry performed as per standard practice for the main cohort A. Subjects with CD22+ cells, but < 70% B-ALL blast cells expressing CD22 are eligible to be enrolled in the exploratory Cohort B
- ECOG performance status 0 or 1 for subjects ≥ 18 years; Lansky/Karnofsky score ≥ 70 for subjects < 18 years
- Adequate organ function, including renal and hepatic function based on the last assessment performed within the Screening Period.
- Women of childbearing potential must have a negative, highly sensitive serum pregnancy test performed within 7 days. Within the timeframe of this study, female subjects of childbearing potential and their partners, as well as male subjects and their female partners of childbearing potential, must use a highly effective method of birth control from the Screening Period through 12 months after UCART22 administration prior to enrollment.
- Subject is pregnant or breastfeeding;
- Burkitt cell leukemia;
- More than 1 allogeneic HSCT received;
- Prior autologous CAR T-cell therapy or investigational cell therapy within 90 days prior to enrollment; or prior allogeneic CAR T-cell therapy at any time prior to enrollment
- Prior CD22 -directed CAR T-cell therapy;
- Phase 1: Prior monoclonal and/or bispecific antibody within 30 days or 5 half-lives (whichever is longer) prior to enrollment; Phase 2: Prior monoclonal and/or bispecific antibody within 14 days or 5 half-lives (whichever is longer) prior to enrollment
- Known history of CRS > Grade 3 or ICANS ≥ Grade 3 related to prior CD19 CAR T-cell therapy
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Canada
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, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
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.