Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T

Sponsor
Calibr, a division of Scripps Research (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04488354
Collaborator
(none)
36
Enrollment
8
Locations
1
Arm
186.3
Anticipated Duration (Months)
4.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells in all clinical trials including NCT04450069, A Phase 1, Open-label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the Combination of CLBR001 and SWI019 in Patients With Relapsed/Refractory B-cell Malignancies.

Detailed Description

Patients will be enrolled following either the completion or early termination/discontinuation from Study NCT04450069 or any protocol in which patients were administered CLBR001. Patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. Patients will be followed for up to 15 years post CLBR001 infusion and will continue to be monitored for safety, immunogenicity, and efficacy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study to Evaluate the Long-Term Safety of CLBR001, A Lentiviral Based Chimeric Antigen Receptor, In Patients With B-Cell Malignancies Previously Administered CLBR001
Actual Study Start Date :
Jan 21, 2021
Anticipated Primary Completion Date :
Aug 1, 2036
Anticipated Study Completion Date :
Aug 1, 2036

Arms and Interventions

ArmIntervention/Treatment
Experimental: CLBR001 treated patients

Patients who have been administered with CLBR001

Combination Product: CLBR001 and SWI019
No study drug is administered in this study. Patients who have received CLBR001 autologous CAR-T cells will be evaluated in this trial for long-term safety and efficacy

Outcome Measures

Primary Outcome Measures

  1. Incidence and duration of new adverse events, late onset adverse events, and events of special interest [15 years]

    To measure the incidence and duration of new adverse events, late onset adverse events, and events of special interest

  2. Incidence and duration of new serious adverse events [15 years]

    To measure the incidence and duration of new serious adverse events

  3. Incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001 [15 years]

    The measure the incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001

  4. Incidence of new malignancies [15 years]

    The measure the incidence of new malignancies

Secondary Outcome Measures

  1. Overall response [15 years]

    To evaluate clinical efficacy by measuring the overall response by Response Evaluation Criteria In Lymphoma (RECIL) 2017

  2. Duration of response [15 years]

    To evaluate clinical efficacy by measuring the duration of response

  3. Progression free survival [15 years]

    To evaluate clinical efficacy by measuring progression free survival

  4. Proportion of patients undergoing stem cell transplant [15 years]

    To evaluate the proportion of patients undergoing stem cell transplant

  5. Number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens [3, 6, 9,12 and 24 months]

    To measure the number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens

  6. Detectable replication competent lentivirus (RCL) [15 years]

    To measure detectable replication competent lentivirus (RCL)

  7. Titer of anti-drug antibody (ADA) for CLBR001 and SWI019 [3, 6, 12 months]

    To evaluate immunogenicity by measuring the titer of ADA for CLBR001 and SWI019

  8. Duration of detection of ADA for CLBR001 and SWI019 [3, 6, 12 months]

    To evaluate immunogenicity by measuring the duration of detection of ADA for CLBR001 and SWI019

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All patients who received at least one CLBR001 cell dose and have either discontinued early or completed the core treatment protocol or any protocol such as a managed access protocol as applicable.

  • Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria:
  • There are no specific exclusion criteria for this study

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1City of Hope National Medical CenterDuarteCaliforniaUnited States91010
2University of California at San DiegoSan DiegoCaliforniaUnited States92093
3University of ChicagoChicagoIllinoisUnited States60637
4Masonic Cancer Center, University of MinnesotaMinneapolisMinnesotaUnited States55455
5Weill Cornell Medical College - New York Presbyterian HospitalNew YorkNew YorkUnited States10065
6Wake Forest Baptist HealthWinston-SalemNorth CarolinaUnited States27157
7Sarah Cannon Research Institute - Tennessee OncologyNashvilleTennesseeUnited States37203
8Sarah Cannon Research Institute - Texas Transplant InstituteSan AntonioTexasUnited States78229

Sponsors and Collaborators

  • Calibr, a division of Scripps Research

Investigators

  • Principal Investigator: Carolyn Mulroney, M.D., University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Calibr, a division of Scripps Research
ClinicalTrials.gov Identifier:
NCT04488354
Other Study ID Numbers:
  • CBR-sCAR19-3002
First Posted:
Jul 28, 2020
Last Update Posted:
Dec 2, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Calibr, a division of Scripps Research
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 2, 2021