| CTRI Number |
CTRI/2025/01/079364 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cell and Gene Therapy] |
| Study Design |
Other |
|
Public Title of Study
|
To study how safe and efficacious a type of CAR-T therapy works in patients with recurring blood cancer (relapsed/refractory Multiple Myeloma) |
|
Scientific Title of Study
|
Phase I/II study of BCMA directed humanised CAR-T cell therapy (hBCMA) in
patients with relapsed/refractory Multiple myeloma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IACT/2024/001 |
Protocol Number |
| Protocol Version 1.1 dated 25/10/2024 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manju Sengar |
| Designation |
Professor, Department of Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Room No 81, Adult Hematolymphoid Unit, Main Building, Tata Memorial Centre
Dr E Borges Road
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177211 |
| Fax |
|
| Email |
manju.sengar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Sengar |
| Designation |
Professor, Department of Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Room No 81, Adult Hematolymphoid Unit, Main Building, Tata Memorial Centre
Dr E Borges Road
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177211 |
| Fax |
|
| Email |
manju.sengar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju Sengar |
| Designation |
Professor, Department of Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Room No 81, Adult Hematolymphoid Unit, Main Building, Tata Memorial Centre
Dr E Borges Road
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177211 |
| Fax |
|
| Email |
manju.sengar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Hospital Faridabad, Mata Amritanandamayi Marg, Sector 88, Faridabad, Haryana, India, 121002 |
| Amrita Hospital Kochi, Ponekkara, AIMS P.O, Kochi, Kerala, India - 682 041 |
| Deenanath Mangeshkar Hospital and Research center, Near Mhatre Bridge, Erandawane, Pune, Maharashtra India 411004 |
| Immunoadoptive Cell Therapy Private Limited (ImmunoACT)
R-977, TTC Industrial Area, MIDC, Rabale, Navi Mumbai - India 400701 |
| SMBT Institute of Medical Science and Research Center, Nandi Hills, Dhamangaon- Ghoti, Tal- Igatpuri, Nashik, Maharashtra- 422403. India Nashik |
| Tata Memorial Hospital, Room No 81, Adult Hematolymphoid Unit, Dr E Borges Road, Parel, Mumbai India - 400012 |
|
|
Primary Sponsor
|
| Name |
Immunoadoptive Cell Therapy Private Limited (ImmunoACT) |
| Address |
1st Floor, Plot no R-977, TTC Industrial Area, MIDC Rabale Navi Mumbai, 400701, Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prashant Mehta |
Amrita Hospital Faridabad |
Room 7005, Department of Hematology/Medical Oncology and BMT, Mata Amritanandamayi Marg, Sector 88, Faridabad, Haryana 121002
Faridabad
HARYANA |
9013590847
prashantm@fbd.amrita.edu |
| Dr Neeraj Sidharthan |
Amrita Hospital Kochi |
Room No 5, 4th floor, G block, Department of clinical Haematology, Transplant and Cellular Therapy, Ponekkara, AIMS P.O, Kochi, Kerala, India - 682 041
Ernakulam
KERALA |
994604764
neerajsidharthan@aims.amrita.edu |
| Dr Sameer Melinkeri |
Deenanath Mangeshkar Hospital & Research Center |
Room No 7, Department of Clinical Hematology, Near Mhatre Bridge, Erandawane, Pune, Maharashtra 411004
Mumbai
MAHARASHTRA |
02040151000
docmelinkeri@yahoo.com |
| Dr Girish Badarkhe |
SMBT Institute of Medical Sciences and Research centre |
OPD- 17 Room No 3, Department of Hemato-oncology and BMT, Nandi Hills,
Dhamangaon- Ghoti,
Tal- Igatpuri, Nashik,
Maharashtra- 422403.
Nashik
Nashik
MAHARASHTRA |
9902993531
haemgiri@gmail.com |
| Dr Manju Sengar |
Tata Memorial Centre, Department of Medical Oncology |
Room No 81, Adult Hematolymphoid Unit, Main Building, Tata Memorial Hospital, Dr. E Borges Road
Parel
Mumbai-400012
Mumbai
MAHARASHTRA |
22-24177211
manju.sengar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Clinical Studies (Apollo Hospital, Chennai) |
Approved |
| Institutional Ethics Committee, Amrita Hospital Faridabad |
Submittted/Under Review |
| Institutional Ethics Committee, Amrita Hospital Kochi |
Submittted/Under Review |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital |
Approved |
| Institutional Ethics Committee, SMBT |
Approved |
| Institutional Ethics Committee, Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C900||Multiple myeloma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
hBCMA CAR-T cell |
The investigational drug product is hBCMA is BCMA targeted Chimeric Antigen
Receptor (CAR) T cells for cancer treatment. It is a cell and gene therapy product.
hBCMA cells are BCMA-directed genetically modified autologous T-cell for
relapsed/refractory Multiple Myeloma. The intervention will be administered via IV on a single day. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age - 18 years and above
2. ECOG 0-2
3. Subjects with diagnosis of multiple myeloma who have received at least two lines of therapy or double refractory to immunomodulatory drug (IMiD) and proteasome inhibitor (PI) combination or refractory to last line of treatment.
4. Measurable Disease defined by at least one of the criteria
a. Serum M-protein greater or equal to 1.0 g/dL
b. Urine M-protein greater or equal to 200 mg/24 h
c. Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL
(100 mg/L) provided serum FLC ratio is abnormal
d. A biopsy-proven evaluable plasmacytoma
e. Bone marrow plasma cells ≥ 10% of total bone marrow cells
5. All sexually active WCBP and all sexually active male subjects must agree to use
effective methods of birth control throughout the study.
6. Recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.
7. Ability and willingness to adhere to the study visit schedule and all protocol requirements.
8. Written informed consent. |
|
| ExclusionCriteria |
| Details |
1 Subjects who received the following treatments will be excluded
a. Any therapy that is targeted to B-cell maturation antigen (BCMA)
b. Ongoing treatment with chronic immunosuppressants since 2 weeks (eg cyclosporine or systemic steroids at any dose)
c. Previous history of an allogeneic bone marrow transplantation or treatment with any gene therapy-based therapeutic for cancer
Any prior systemic therapy for MM within 14 days prior to scheduled protocol required leukapheresis
2. LVEF less than 50 percent
3. Subjects with a history of class III or IV congestive heart failure (CHF) or severe non ischemic cardiomyopathy, history of stroke, unstable angina, myocardial infarction, or
ventricular arrhythmia within the previous 6 months
4. Subjects with known active, or prior history of central nervous system (CNS) involvement
5. Subjects with plasma cell leukaemia
6. Subjects with solitary plasmacytomas without other evidence of measurable disease
7. Subjects with second malignancies in addition to myeloma if the second malignancy has required therapy in the last 3 years or is not in complete remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or incidental histologic finding of prostate cancer (T1a or T1b using the TNM tumour, nodes, metastasis clinical staging system) or prostate cancer that is
curative
8. Inadequate hepatic function defined by AST and ALT greater than 5 times the upper limit of normal (ULN) and direct bilirubin greater than 2 times ULN
9. Inadequate renal function defined by CrCl less than or equal to 30 ml/min using Cockcroft-Gault equation
10. International ratio (INR) or partial thromboplastin time (PTT) greater than three times ULN, unless on a stable dose of anticoagulant for a thromboembolic event, or history of grade 2 or more hemorrhage within 30 days
11. Evidence of human immunodeficiency virus (HIV) infection
12. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV)
13. Seropositive for and with active viral infection with hepatitis C virus (HCV)
14. Pregnant or lactating women
15. Significant comorbidities or disease which in the judgement of the Investigator would place the subject at undue risk or interfere with the study
16. Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis
17. History of cerebrovascular accident or seizures in last 6 months
18. Patient with history of auto-immune disorders to be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Phase I
Safety
The MTD is the highest dose that causes DLTs in greater than or equal to 2 of 6 subjects. For a dose level to be declared the MTD at least 5 evaluable subject must be enrolled with no DLTs reported or 6 evaluable subjects if 1 subject experiences a DLT.
Phase II
Overall Response Rate
Percentage of subjects who achieved a PR or better
according to IMWG Uniform Response Criteria for Multiple Myeloma. |
Phase I
Safety
DLT will be assessed within 21 days post administration
of hBCMA CAR
Phase II
Overall Response Rate: 3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Phase I
hBCMA persistence and quantification |
Day -1, Day7, Day14, Day 21, Day28, month 3, month 6, month 9, month 12. This will be done only till two sequential tests are negative. |
| Phase I & II: Overall Survival |
5 years : (Time from the first infusion to time of death due to any cause) |
| Phase I & II: Progression Free Survival |
5 years (Time from the first infusion to first documentation of
progressive disease (PD), or death due to any cause, whichever occurs first)
|
| Phase I: Overall Response Rate |
Month 3 |
| Phase I & II: Duration of Response |
5 year Follow up period:(Time from first documentation of response of PR or better to first documentation of response to disease progression or death from any cause, whichever occurs first)
|
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Multiple Myeloma is difficult to treat disease. It is incurable with current available treatment
options. Also, most of these options are beyond the reach of our population due to their
availability and affordability.
Anti-BCMA CAR-T cell therapy is a proven effective option which is not available in India. The
treatment cost of the approved CART therapies in USA is exorbitant and ranges from
$419,500 to $465,000. Thus, there is an urgent need to develop an indigenous, cost-effective
CAR T-cell therapy for Myeloma in India.
This is a phase I/II study BCMA-directed humanized CAR-T cell therapy in patients with
relapsed/refractory Multiple myeloma. The primary aim of the Phase I part of the study is to
assess the safety of hBCMA and the Phase II study will assess the efficacy of hBCMA. In
Phase I a 3 + 3 dose escalation model will be utilized to establish safety. In Phase II a total of
39 patients will be enrolled at the dose level that has already been established, to assess the
efficacy. |