Acute Lymphoblastic Leukemia, AdultPhase 1/2NCT03676504
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
A Phase 1/2 study testing CD19.CAR T Cells, Fludarabine and Cyclophosphamide in people with Acute Lymphoblastic Leukemia, Adult and Acute Lymphoblastic Leukemia, Pediatric, run by University Hospital Heidelberg at 2 sites in Germany.
Trial summary
Adult patients with r/r acute lymphoblastic leukemia (ALL) (stratum I), r/r Non-Hodgkin's lymphoma (NHL) including chronic lymphocytic leukaemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or mantle cell lymphoma (MCL) (stratum II) as well as paediatric patients with r/r ALL (stratum III)… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Adult, Acute Lymphoblastic Leukemia, Pediatric, Chronic Lymphocytic Leukemia
- What is being tested?
- CD19.CAR T Cells, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesGermany
- Study dates
- 7 Sep 2018to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stratum I/II (Adults):
- Confirmed CD19+ ALL, CLL, DLBCL, FL or MCL in patients ≥ 18 years
- ALL (Ph+ and Ph-): Confirmed CD19+ ALL by cytology and flow cytometry (FACS) AND
- Relapsed or refractory disease (including "molecular relapse" with minimal residual disease (MRD) levels > 10^-3 at two occasions > 2 weeks apart) with confirmed CD19 expression on malignant cells in relapse
- Any relapse after allogeneic stem cell transplantation (alloSCT) (≥ 6 months from alloSCT at time of CAR T cell infusion) OR
- Any relapse failing to achieve an MRD level of < 10^-3 after ≥ 2 lines of treatment OR
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- Primary refractory as defined by not achieving a complete remission (CR) after ≥ 2 lines of treatment
- CLL/NHL: Confirmed CD19+ CLL/NHL (including CLL, DLBCL, FL or MCL) with
- CLL in need of treatment with:
- Early relapse (within 2 years) after end of chemoimmunotherapy or chemoimmunotherapy refractoriness plus failure or intolerance of both Bruton's tyrosine kinase Inhibitor (BTKi) and B-cell lymphoma 2 inhibitors (BCL-2i) OR
- Relapse after alloSCT, ineligible for or refractory to standard interventions (donor lymphocyte infusions (DLI), CD20 antibodies, chemoimmunotherapy)
- DLBCL with:
- Refractoriness to a 2nd or later line of chemoimmunotherapy OR
- Relapse after autologous stem cell transplantation (autoSCT) plus ineligibility for alloSCT (including refractoriness to one line of salvage chemoimmunotherapy) OR
- Relapse after alloSCT
- FL in need of treatment with:
- Relapse <2 years after chemoimmunotherapy AND ineligibility for or failure of autologous stem cell transplantation (autoSCT) AND ineligibility for or failure of idelalisib OR
- Relapse after alloSCT, ineligible for or refractory to standard interventions (DLI, CD20 antibodies, chemoimmunotherapy)
- MCL with:
- Relapse after standard first-line therapy AND ineligibility for or failure to BTKi salvage therapy OR
- Relapse after alloSCT AND ineligibility for or failure to BTKi salvage therapy
- Measurable disease/MRD at time of enrollment
- Life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at the time of screening
- Adequate organ function:
- Renal function defined as: serum creatinine of ≤ 2 x ULN or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m^2
- Liver function defined as:
- ALT ≤ 5 times the ULN for the respective age
- Bilirubin ≤ 2.0 mg/dl with the exception of patients with hyperbilirubinemia explained by Gilbert-Meulengracht syndrome (may be included if total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) or extrahepatic disease (e.g. chronic hemolytic anemia)
- minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation > 90% on room air
- Hemodynamic stability and left ventricular ejection fraction (LVEF) ≥ 40% as confirmed by echocardiogram
- Absolute neutrophil count (ANC) ≥ 500/mm3
- Absolute lymphocyte count (ALC) ≥ 100/mm3
- Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants must agree to use highly effective methods of contraception for one year following CD19.CAR T cell therapy
- Ability to understand the nature of the trial and the trial related procedures
- Written informed consent must be obtained prior to any screening procedures
- Stratum III (Children and Adolescents with ALL):
- Age of > 3 years until < 18 years at the time of screening
- CD19+ ALL (Ph+ and Ph-) confirmed by cytology and flow cytometry (FACS) AND
- Relapsed or refractory disease (including "molecular relapse" with polymerase chain reaction (PCR) MRD > 10^-3 at two occasions > 2 weeks apart) with confirmed CD19 expression on malignant cells in relapse
- Any relapse after alloSCT (≥ 6 months from alloSCT at time of CAR T cell infusion) OR
- Any relapse failing to achieve an MRD level of < 10^-3 after ≥ 2 lines of treatment OR
- Primary refractory as defined by not achieving a CR after ≥ 2 lines of treatment
- Measurable disease/MRD at time of enrollment
- Life expectancy ≥ 12 weeks
- ECOG performance status ≤ 2 (age ≥ 16 years) or Lansky performance status ≥ 50 (age < 16 years) at the time of screening
- Adequate organ function:
- Renal function defined as serum creatinine-clearance ≥ 30 mL/min/1.73 m^2
- Liver function defined as:
- ALT ≤ 5 times the ULN for the respective age
- Bilirubin ≤ 2.0 mg/dl with the exception of patients with hyperbilirubinemia explained by Gilbert-Meulengracht syndrome or extrahepatic disease (e.g. chronic hemolytic anemia)
- minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation > 90% on room air
- Hemodynamic stability and LVEF ≥ 40% or shortening fraction > 29% as confirmed by echocardiogram
- ANC) ≥ 500/mm3
- ALC ≥ 100/mm3
- Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and postpubertal male participants must agree to use highly effective methods of contraception for one year following CD19.CAR T cell therapy
- Written informed consent of the study patient and/or the legal representative must be obtained prior to any screening procedures
Who cannot join
- Stratum I/II (Adults):
- The following medications are excluded:
- Immunosuppressive medication with the exception of ≤ 30 mg prednisolone/d or equivalent at the time of CAR T cell transfusion
- Bridging/maintenance therapy including chemo- and immunotherapy must be stopped ≥ 2 weeks prior to leukapheresis, but can be continued between leukapheresis and lymphodepletion
- Intrathecal chemotherapy is possible at any time, but not during lymphodepletion until 14 days after CD19.CAR T cell transfusion
- Any DLI must be completed > 6 weeks prior to CD19.CAR T cell infusion
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- Florid/acute or chronic Graft-versus-Host disease (GvHD)
- Uncontrolled active hepatitis B or C
- HIV-positivity
- Uncontrolled acute life-threatening bacterial, viral or fungal infection
- Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure New York Heart Association (NYHA) III-IV, uncontrolled diabetes mellitus, uncontrolled hyperlipidemia)
- Unstable angina and/or myocardial infarction within 3 months prior to screening
- Any previous or concurrent malignancy.
- The following exceptions do NOT constitute exclusion criteria:
- Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)
- In situ carcinoma of the cervix or breast, treated curatively without evidence of recurrence ≥ 3 years prior to the study
- CLL or FL transformed into an aggressive B cell lymphoma
- A primary malignancy which is in complete remission for ≥ 5 years
- Pregnant or nursing (lactating) women
- Intolerance to the excipients of the cell product
- Active central nervous System (CNS) involvement in ALL patient at the time of screening is not an exclusion criterion, but patients with CNS 3 status at clinical screening (d-14) are not eligible for CD19.CAR T cell transfusion
- Participation in another clinical trial at the time of screening
- Stratum III (Children and Adolescents with ALL):
- The following medications are excluded:
- immunosuppressive medication with the exception of < 0.5 mg/d*kg body weight (BW) prednisolone-equivalent at the time of CD19.CAR T cell transfusion
- Bridging/Maintenance therapy including chemo- and immunotherapy must be stopped ≥ 2 weeks prior to leukapheresis, but can be continued between leukapheresis and lymphodepletion
- Intrathecal chemotherapy is possible at any time, but not during lymphodepletion until 14 days after CD19.CAR T cell transfusion
- Any DLI must be completed > 6 weeks prior to CD19.CAR T cell infusion
- Florid/acute or chronic GvHD
- Uncontrolled active hepatitis B or C
- HIV-positivity
- Uncontrolled acute life-threatening bacterial, viral or fungal infection
- Severe concomitant disease (e.g. any life-limiting genetic disorder). Patients with Down Syndrome will not be excluded.
- Any previous or concurrent malignancy.
- The following exceptions do not constitute exclusion criteria:
- Lymphoblastic lymphoma transformed into a CD19+ acute lymphoblastic leukemia
- A primary malignancy which is in complete remission for ≥ 5 years
- Pregnant or nursing (lactating) women
- Intolerance to the excipients of the cell product
- Active CNS involvement at the time of screening is not an exclusion criterion, but patients with CNS 3 status at clinical screening (d-14) are not eligible for CD19.CAR T cell transfusion
- Participation in another clinical trial at the time of screening
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Heidelberg
Heidelberg
Prof. Dr. Michael Schmitt, +49-6221-566614, michael.schmitt@med.uni-heidelberg.de
- Recruiting
University Hospital Heidelberg
Heidelberg
Prof. Dr. Michael Schmitt, +49-6221-566614, michael.schmitt@med.uni-heidelberg.de
Prof. Dr. Michael Schmitt
About this study
Official title: Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Lymphocytes Transduced by RV-SFG.CD19.CD28.4-1BBzeta Retroviral Vector - a Unicenter Phase I/II Clinical Trial
Adult patients with r/r acute lymphoblastic leukemia (ALL) (stratum I), r/r Non-Hodgkin's lymphoma (NHL) including chronic lymphocytic leukaemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or mantle cell lymphoma (MCL) (stratum II) as well as paediatric patients with r/r ALL (stratum III) will be treated with autologous T-lymphocytes transduced by the third-generation RV-SFG.CD19.CD28.4-1BBzeta retroviral vector. The main purpose of this study is to evaluate safety and feasibility of escalating CD19.CAR T cell doses (0,1-20×20^7 transduced cells/m^2) after lymphodepletion with fludarabine and cyclophosphamide.
- Conditions
- Acute Lymphoblastic Leukemia, Adult, Acute Lymphoblastic Leukemia, Pediatric, Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma
- Being tested
- CD19.CAR T Cells, Fludarabine, Cyclophosphamide
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19.CAR T CellsBiological
Dose Level 1: 1×10^6 transduced cells/m^2; Dose Level 2: 5×10^6 transduced cells/m^2; Dose Level 3: 20×10^6 transduced cells/m^2; Dose Level 4: 5x10^7 transduced cells/m^2; Dose Level 5: 10x10^7 transduced cells/m^2; Dose Level 6: 20x10^7 transduced cells/m^2
FludarabineDrug
3 days of fludarabine 30 mg/m^2/day
CyclophosphamideDrug
3 days of cyclophosphamide 500 mg/m^2/day
| Study group | Role | What they receive |
|---|---|---|
| Stratum I | Experimental | Adult patients with relapsed or refractory ALL Receives: Biological: CD19.CAR T Cells; Drug: Fludarabine; Drug: Cyclophosphamide |
| Stratum II | Experimental | Adult patients with relapsed or refractory CLL, DLBCL, FL or MCL Receives: Biological: CD19.CAR T Cells; Drug: Fludarabine; Drug: Cyclophosphamide |
| Stratum III | Experimental | Pediatric patients with relapsed or refractory ALL Receives: Biological: CD19.CAR T Cells; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of CD19.CAR T cell administration assessing grade and frequency of toxicities including cytokine release syndrome (CRS) and neurotoxicity according to Common Toxicity Criteria for Adverse Events (CTCAE)
Measured: Up to 90 days after CD19.CAR T cell administration
Feasibility of CD19.CAR T cell manufacturing assessing the number of transduced T cells
Measured: Within 45 days prior to CD19.CAR T cell administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start7 Sep 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia, AdultStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Michael Schmitt, University Hospital Heidelberg
- Investigators
- Prof. Dr. Michael Schmitt, Principal investigator, University Hospital Heidelberg, Department VProf. Dr. Andreas Kulozik, Principal investigator, University Hospital Heidelberg, University Medical Center for Children and Adolescents
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676504
- Sponsor's protocol ID
- HD-CAR-1
- Status last verified
- Jul 2024
- First submitted
- 7 Sep 2018
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yousefian S, Schubert ML, Minafra AR, Derigs P, Grassle S, Horne A, Demel UM, Liebaert J, Rothemeier C, Pupp F, Hopken UE, Kronke J, Busse A, Keller U, Schmitt A, Hubschmann D, Muller-Tidow C, Dreger P, Schmitt M, Haas S. A distinct CAR-T cell phenotype mediates therapeutic response at limited doses. Nat Commun. 2026 Jul 29;17(1):7589. doi: 10.1038/s41467-026-76068-4.
PubMed 42527400Derigs P, Schubert ML, Dreger P, Schmitt A, Yousefian S, Haas S, Rothemeier C, Neuber B, Huckelhoven-Krauss A, Bruggemann M, Bernhard H, Kobbe G, Lindemann A, Rummel M, Michels B, Korell F, Ho AD, Muller-Tidow C, Schmitt M. Third-generation anti-CD19 CAR T cells for relapsed/refractory chronic lymphocytic leukemia: a phase 1/2 study. Leukemia. 2024 Nov;38(11):2419-2428. doi: 10.1038/s41375-024-02392-7. Epub 2024 Aug 27.
PubMed 39192036Schubert ML, Schmitt A, Huckelhoven-Krauss A, Neuber B, Kunz A, Waldhoff P, Vonficht D, Yousefian S, Jopp-Saile L, Wang L, Korell F, Keib A, Michels B, Haas D, Sauer T, Derigs P, Kulozik A, Kunz J, Pavel P, Laier S, Wuchter P, Schmier J, Bug G, Lang F, Gokbuget N, Casper J, Gorner M, Finke J, Neubauer A, Ringhoffer M, Wolleschak D, Bruggemann M, Haas S, Ho AD, Muller-Tidow C, Dreger P, Schmitt M. Treatment of adult ALL patients with third-generation CD19-directed CAR T cells: results of a pivotal trial. J Hematol Oncol. 2023 Jul 22;16(1):79. doi: 10.1186/s13045-023-01470-0.
PubMed 37481608Schubert ML, Schmitt A, Sellner L, Neuber B, Kunz J, Wuchter P, Kunz A, Gern U, Michels B, Hofmann S, Huckelhoven-Krauss A, Kulozik A, Ho AD, Muller-Tidow C, Dreger P, Schmitt M. Treatment of patients with relapsed or refractory CD19+ lymphoid disease with T lymphocytes transduced by RV-SFG.CD19.CD28.4-1BBzeta retroviral vector: a unicentre phase I/II clinical trial protocol. BMJ Open. 2019 May 19;9(5):e026644. doi: 10.1136/bmjopen-2018-026644.
PubMed 31110096
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Lymphocytes Transduced by RV-SFG.CD19.CD28.4-1BBzeta Retroviral Vector - a Unicenter Phase I/II Clinical Trial
- ClinicalTrials.gov ID
- NCT03676504
- Acronym / sponsor ID
- HD-CAR-1
- Conditions
- Acute Lymphoblastic Leukemia, Adult, Acute Lymphoblastic Leukemia, Pediatric, Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adult patients with r/r acute lymphoblastic leukemia (ALL) (stratum I), r/r Non-Hodgkin's lymphoma (NHL) including chronic lymphocytic leukaemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or mantle cell lymphoma (MCL) (stratum II) as well as paediatric patients with r/r ALL (stratum III) will be treated with autologous T-lymphocytes transduced by the third-generation RV-SFG.CD19.CD28.4-1BBzeta retroviral vector. The main purpose of this study is to evaluate safety and feasibility of escalating CD19.CAR T cell doses (0,1-20×20^7 transduced cells/m^2) after lymphodepletion with fludarabine and cyclophosphamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stratum I | Experimental | Biological: CD19.CAR T Cells, Drug: Fludarabine, Drug: CyclophosphamideAdult patients with relapsed or refractory ALL |
| Stratum II | Experimental | Biological: CD19.CAR T Cells, Drug: Fludarabine, Drug: CyclophosphamideAdult patients with relapsed or refractory CLL, DLBCL, FL or MCL |
| Stratum III | Experimental | Biological: CD19.CAR T Cells, Drug: Fludarabine, Drug: CyclophosphamidePediatric patients with relapsed or refractory ALL |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (57 listed)
- Confirmed CD19+ ALL, CLL, DLBCL, FL or MCL in patients ≥ 18 years
- ALL (Ph+ and Ph-): Confirmed CD19+ ALL by cytology and flow cytometry (FACS) AND
- Relapsed or refractory disease (including "molecular relapse" with minimal residual disease (MRD) levels > 10^-3 at two occasions > 2 weeks apart) with confirmed CD19 expression on malignant cells in relapse
- CLL/NHL: Confirmed CD19+ CLL/NHL (including CLL, DLBCL, FL or MCL) with
- Measurable disease/MRD at time of enrollment
Key exclusion criteria (41 listed)
- The following medications are excluded:
- Intrathecal chemotherapy is possible at any time, but not during lymphodepletion until 14 days after CD19.CAR T cell transfusion
- Any DLI must be completed > 6 weeks prior to CD19.CAR T cell infusion
- Florid/acute or chronic Graft-versus-Host disease (GvHD)
- Uncontrolled active hepatitis B or C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD19.CAR T CellsDose Level 1: 1×10^6 transduced cells/m^2; Dose Level 2: 5×10^6 transduced cells/m^2; Dose Level 3: 20×10^6 transduced cells/m^2; Dose Level 4: 5x10^7 transduced cells/m^2; Dose Level 5: 10x10^7 transduced cells/m^2; Dose Level 6: 20x10^7 transduced cells/m^2 | Biological | Stratum I, Stratum II, Stratum III |
| Fludarabine3 days of fludarabine 30 mg/m^2/day | Drug | Stratum I, Stratum II, Stratum III |
| Cyclophosphamide3 days of cyclophosphamide 500 mg/m^2/day | Drug | Stratum I, Stratum II, Stratum III |
Primary outcome
Safety of CD19.CAR T cell administration assessing grade and frequency of toxicities including cytokine release syndrome (CRS) and neurotoxicity according to Common Toxicity Criteria for Adverse Events (CTCAE)
Time frame: Up to 90 days after CD19.CAR T cell administration
Feasibility of CD19.CAR T cell manufacturing assessing the number of transduced T cells
Time frame: Within 45 days prior to CD19.CAR T cell administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Derived from this study: PubMed 42527400Yousefian S, Schubert ML, Minafra AR, Derigs P, Grassle S, Horne A, Demel UM, Liebaert J, Rothemeier C, Pupp F, Hopken UE, Kronke J, Busse A, Keller U, Schmitt A, Hubschmann D, Muller-Tidow C, Dreger P, Schmitt M, Haas S. A distinct CAR-T cell phenotype mediates therapeutic response at limited doses. Nat Commun. 2026 Jul 29;17(1):7589. doi: 10.1038/s41467-026-76068-4.
- Derived from this study: PubMed 39192036Derigs P, Schubert ML, Dreger P, Schmitt A, Yousefian S, Haas S, Rothemeier C, Neuber B, Huckelhoven-Krauss A, Bruggemann M, Bernhard H, Kobbe G, Lindemann A, Rummel M, Michels B, Korell F, Ho AD, Muller-Tidow C, Schmitt M. Third-generation anti-CD19 CAR T cells for relapsed/refractory chronic lymphocytic leukemia: a phase 1/2 study. Leukemia. 2024 Nov;38(11):2419-2428. doi: 10.1038/s41375-024-02392-7. Epub 2024 Aug 27.
- Derived from this study: PubMed 37481608Schubert ML, Schmitt A, Huckelhoven-Krauss A, Neuber B, Kunz A, Waldhoff P, Vonficht D, Yousefian S, Jopp-Saile L, Wang L, Korell F, Keib A, Michels B, Haas D, Sauer T, Derigs P, Kulozik A, Kunz J, Pavel P, Laier S, Wuchter P, Schmier J, Bug G, Lang F, Gokbuget N, Casper J, Gorner M, Finke J, Neubauer A, Ringhoffer M, Wolleschak D, Bruggemann M, Haas S, Ho AD, Muller-Tidow C, Dreger P, Schmitt M. Treatment of adult ALL patients with third-generation CD19-directed CAR T cells: results of a pivotal trial. J Hematol Oncol. 2023 Jul 22;16(1):79. doi: 10.1186/s13045-023-01470-0.
- Derived from this study: PubMed 31110096Schubert ML, Schmitt A, Sellner L, Neuber B, Kunz J, Wuchter P, Kunz A, Gern U, Michels B, Hofmann S, Huckelhoven-Krauss A, Kulozik A, Ho AD, Muller-Tidow C, Dreger P, Schmitt M. Treatment of patients with relapsed or refractory CD19+ lymphoid disease with T lymphocytes transduced by RV-SFG.CD19.CD28.4-1BBzeta retroviral vector: a unicentre phase I/II clinical trial protocol. BMJ Open. 2019 May 19;9(5):e026644. doi: 10.1136/bmjopen-2018-026644.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Dr. Michael Schmitt principal investigator
University Hospital Heidelberg, Department V
Prof. Dr. Andreas Kulozik principal investigator
University Hospital Heidelberg, University Medical Center for Children and Adolescents
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD19.CAR T Cells, Fludarabine and Cyclophosphamide in people with Acute Lymphoblastic Leukemia, Adult and Acute Lymphoblastic Leukemia, Pediatric, run by University Hospital Heidelberg at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 57 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. Michael Schmitt (+49-6221-566614, michael.schmitt@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of CD19.CAR T cell administration assessing grade and frequency of toxicities including cytokine release syndrome (CRS) and neurotoxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) (time frame: Up to 90 days after CD19.CAR T cell administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03676504, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.