NCT05168748WithdrawnPhase 1
CD19- and CD22-directed CAR-T Cell Therapy in Patients With Acute Lymphoblastic Leukemia
Phase I, Open Label, Multicenter, Dose Escalation and Expansion Study of IMJ995 in Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 21 Dec 2022
Reason given: Sponsor's decision
Brief summary (registry, in English)
This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous chimeric antigen receptor (CAR) T cells targeting both CD19 and CD22, manufactured with T-Charge(TM) process. CAR-T cells will be investigated as single agent in pediatric and adult acute lymphoblastic leukemia (ALL).
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 3 Nov 2021
- Start date
- 24 Jan 2023
- Primary completion date
- 13 Aug 2026
- Lead sponsor
- Novartis Pharmaceuticals
- NCT number
- NCT05168748
- EudraCT number
- 2021-000677-89
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Allogeneic HCT within 12 weeks prior to screening.
- Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome.
Other illness
- Presence of isolated extra-medullary disease, testicular involvement or bulky disease
- History of active neurological auto immune or inflammatory disorders
- Other protocol-defined inclusion/exclusion criteria may apply.
Other
- Patients with Burkitt's lymphoma/leukemia
Who the study is looking for
- All patients:
- Evidence of CD19 and/or CD22 cell surface expression on B-ALL blasts in bone marrow or peripheral blood by flow cytometry at time of relapse or prior to study entry.
- Pediatric, adolescent and young adult ALL patients:
- 1 - 29 years of age at the time of informed consent form (ICF) signature.
- Relapsed or refractory CD19+ and/or CD22+ ALL after 3 or more lines of treatment OR after allogeneic HCT.
- Must have received a CD19-directed CAR-T treatment (with or without blinatumomab), unless prior loss of CD19 cell surface expression occurred or have not been eligible for CD19 directed CAR-T treatment.
- Lansky (age < 16 years), Karnofsky (age 16-25 years) performance status ≥ 60%. ECOG (age >25 years) performance status that is either 0 or 1 at screening.
- Adult ALL patients aged ≥30 years:
- ≥30 years of age at the time of informed consent form (ICF) signature.
- Refractory or relapsed CD19+ and/or CD22+ ALL including at least one of the following:
- After allogeneic HCT
- After 2 or more lines of treatment, including blinatumomab and/or inotuzumab
- Primary refractory disease (defined as failure to achieve a CR at the end of at least 1 induction chemotherapy)
- First relapse occurring within 12 months from first remission
- ECOG performance status that is either 0 or 1 at screening.
Age in the registry: 1 year to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.